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Trial record 12 of 28 for:    pandemrix

Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age

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ClinicalTrials.gov Identifier: NCT01310413
Recruitment Status : Completed
First Posted : March 8, 2011
Results First Posted : March 31, 2014
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Influenza A (H5N1) Virus monovalent vaccine
Biological: Saline placebo
Enrollment 842

Recruitment Details The study included a first 385-days Blinded Phase (all subjects), followed by a 385-days Unblinded Phase. In this phase, subjects who received the placebo in the Blinded Phase were offered, after completing the Blinded Phase, 2 doses of Influenza A (H5N1) Virus monovalent vaccine administered for Dose 1 within a short delay of Day 385 (Day U0).
Pre-assignment Details A total of 842 subjects were enrolled in the study in its Blinded Phase part. This number was later amended down to 838, following corrections for wrong subject number allocation and randomization errors.
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group Placebo/Influenza A (H5N1) Adjuvanted Group
Hide Arm/Group Description Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
Period Title: Day 0 to Day 385
Started 199 198 210 75 76 80 0 [1]
Completed 172 190 203 67 73 77 0 [1]
Not Completed 27 8 7 8 3 3 0
Reason Not Completed
Withdrawal by Subject             5             2             0             2             1             1             0
Lost to Follow-up             18             3             3             5             1             2             0
Migrated/moved from study area             3             3             1             1             1             0             0
Other             1             0             3             0             0             0             0
[1]
This group is only followed during the Unblinded Phase of the study, from Days U0 to U385.
Period Title: From Day U0 to Day U385
Started 0 [1] 0 [1] 0 [1] 0 [2] 0 [2] 0 [2] 155 [3]
Completed 0 [1] 0 [1] 0 [1] 0 [2] 0 [2] 0 [2] 152 [3]
Not Completed 0 0 0 0 0 0 3
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             0             1
Lost to Follow-up             0             0             0             0             0             0             2
[1]
Subjects from this group were not included in Day U0 to Day U42 analysis as per study protocol.
[2]
Eligible subjects who provided consent were included in Placebo/Influenza A (H5N1) Adjuvanted Group.
[3]
Upto Day U42
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group Total
Hide Arm/Group Description Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). Total of all reporting groups
Overall Number of Baseline Participants 199 198 210 75 76 80 838
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 199 participants 198 participants 210 participants 75 participants 76 participants 80 participants 838 participants
21.7  (8.17) 70.5  (21.71) 160.8  (28.21) 22.6  (8.17) 65.2  (20.2) 156.0  (31.29) 84.9  (61.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 199 participants 198 participants 210 participants 75 participants 76 participants 80 participants 838 participants
Female
92
  46.2%
90
  45.5%
103
  49.0%
39
  52.0%
35
  46.1%
42
  52.5%
401
  47.9%
Male
107
  53.8%
108
  54.5%
107
  51.0%
36
  48.0%
41
  53.9%
38
  47.5%
437
  52.1%
1.Primary Outcome
Title Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
Hide Description A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.
Time Frame At Day 42.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 175 185 203 64 71 76
Measure Type: Number
Unit of Measure: Subject
175 184 201 0 0 1
2.Secondary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
Hide Description HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.
Time Frame At Days 0 and 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 182 184 204 67 71 76
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
A/INDO, Day 0 [N=182;184;204;67;71;76]
5.3
(5.1 to 5.5)
5.6
(5.3 to 5.9)
5.7
(5.4 to 6.1)
5.3
(5.0 to 5.7)
5.6
(5.1 to 6.0)
5.4
(5.1 to 5.8)
A/INDO, Day 21 [N=179;184;204;67;70;76]
38.7
(33.9 to 44.2)
44.6
(39.2 to 50.9)
35.3
(31.7 to 39.5)
5.2
(5.0 to 5.4)
5.4
(5.0 to 5.7)
5.4
(5.1 to 5.7)
3.Secondary Outcome
Title Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
Hide Description A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.
Time Frame At Days 0 and 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 182 184 204 67 71 76
Measure Type: Number
Unit of Measure: Subject
A/INDO, Day 0 [N=182;184;204;67;71;76] 1 2 1 0 0 0
A/INDO, Day 21 [N=179;184;204;67;70;76] 105 110 108 0 1 0
4.Secondary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Hide Description

A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.

As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

Time Frame At Days 21 and 42
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Hide Analysis Population Description
Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 179 185 204 67 71 76
Measure Type: Number
Unit of Measure: Subject
A/INDO, Day 21 [N=179;183;204;67;70;76] 103 107 105 0 0 0
A/INDO, Day 42 [N=175;184;203;64;71;76] 175 183 201 0 0 1
5.Secondary Outcome
Title Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Hide Description GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.
Time Frame At Days 21 and 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 179 185 204 67 71 76
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
A/INDO, Day 21 [N=179;183;204;67;70;76]
7.3
(6.4 to 8.4)
8.0
(7.0 to 9.1)
6.2
(5.5 to 6.9)
1.0
(0.9 to 1.0)
1.0
(0.9 to 1.0)
1.0
(0.9 to 1.1)
A/INDO, Day 42 [N=175;184;203;64;71;76]
148.5
(134.5 to 164.1)
96.9
(85.3 to 110.1)
72.4
(63.9 to 82.0)
1.0
(0.9 to 1.0)
1.0
(0.9 to 1.0)
1.1
(1.0 to 1.2)
6.Secondary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
Hide Description

HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.

Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.

Time Frame At Day 0 and Day 182.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 107 101 100 36 37 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titre
A/INDO, Day 0 [N=107;101;100;36;37;35]
5.1
(5.0 to 5.2)
5.2
(5.0 to 5.4)
5.6
(5.2 to 6.0)
5.3
(4.9 to 5.7)
5.2
(4.8 to 5.8)
5.4
(4.8 to 6.0)
A/INDO, Day 182 [N=84;89;87;29;34;31]
90.6
(78.1 to 105.0)
57.4
(50.8 to 64.9)
50.2
(43.3 to 58.2)
5.0
(5.0 to 5.0)
5.4
(4.9 to 6.0)
5.4
(4.9 to 5.9)
7.Secondary Outcome
Title Number of Subjects Seroprotected as Regards Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
Hide Description

A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.

As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

Time Frame At Day 0 and Day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 182 184 204 67 71 76
Measure Type: Number
Unit of Measure: Subject
A/INDO, Day 0 [N=182;184;204;67;71;76] 1 2 1 0 0 0
A/INDO, Day 182 [N=84;89;87;29;34;31] 80 75 63 0 0 0
8.Secondary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain
Hide Description

HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.

As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

Time Frame At Day 42.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 175 185 203 64 71 76
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
777.1
(705.6 to 855.9)
543.8
(484.9 to 609.8)
416.2
(371.5 to 466.2)
5.1
(4.9 to 5.3)
5.4
(5.0 to 5.7)
5.8
(5.3 to 6.3)
9.Secondary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Hide Description A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.
Time Frame At Day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 182, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 182 were available
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
SSubjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 84 89 87 29 34 31
Measure Type: Number
Unit of Measure: Subject
80 75 61 0 0 0
10.Secondary Outcome
Title Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Hide Description GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.
Time Frame At Day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 182, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 182 were available
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 84 89 87 29 34 31
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
17.8
(15.3 to 20.8)
11.0
(9.7 to 12.4)
8.8
(7.5 to 10.4)
1.0
(0.9 to 1.0)
1.1
(1.0 to 1.2)
1.0
(0.9 to 1.2)
11.Secondary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
Hide Description

HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.

As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

Time Frame At Day 0 and Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 182 184 204 67 71 76
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
A/INDO, Day 0 [N=182;184;204;67;71;76]
5.3
(5.1 to 5.5)
5.6
(5.3 to 5.9)
5.7
(5.4 to 6.1)
5.3
(5.0 to 5.7)
5.6
(5.1 to 6.0)
5.4
(5.1 to 5.8)
A/INDO, Day 385 [N=63;85;95;26;34;36]
65.6
(55.9 to 76.9)
32.8
(28.1 to 38.4)
21.6
(18.6 to 25.1)
5.1
(4.9 to 5.4)
5.4
(4.9 to 5.8)
5.3
(4.8 to 5.9)
12.Secondary Outcome
Title Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
Hide Description

A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.

As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

Time Frame At Day 0 and Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 182 184 204 67 71 76
Measure Type: Number
Unit of Measure: Subjects
A/INDO, Day 0 [N=182, 184,204,67,71,76] 1 2 1 0 0 0
A/INDO, Day 385 [N=63;85;95;26;34;36] 54 47 27 0 0 0
13.Secondary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Hide Description A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.
Time Frame At Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 385, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 385 were available
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 63 85 95 26 34 36
Measure Type: Number
Unit of Measure: Subjects
53 45 23 0 0 0
14.Secondary Outcome
Title Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Hide Description GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Time Frame At Day 385.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 385, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 385 were available
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 63 85 95 26 34 36
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold increase
12.1
(10.3 to 14.2)
5.5
(4.7 to 6.6)
3.6
(3.1 to 4.3)
1.0
(0.9 to 1.1)
0.9
(0.8 to 1.0)
1.0
(0.8 to 1.1)
15.Secondary Outcome
Title Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.
Hide Description MN HI antibody titers against the H5N1 A/Indonesia (A/INDO) and H5N1 A/Vietnam (A/VIET) virus strains were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:28.
Time Frame At Days 0, 42, 182 and 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Day 42, 182 and 385 ATP cohorts for immunogenicity, that is, 50 percent of the evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0, 42, 182 and 385 time points.
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 36 39 40 10 11 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
A/INDO, Day 0 [N=36;37;40;7;10;11]
14.00
(14.00 to 14.00)
15.67
(14.37 to 17.08)
15.54
(14.13 to 17.09)
15.46
(12.13 to 19.70)
14.00
(14.00 to 14.00)
14.91
(12.96 to 17.16)
A/INDO, Day 42 [N=34;37;40;6;10;11]
855.62
(597.88 to 1224.47)
657.60
(453.13 to 954.33)
380.62
(277.43 to 522.20)
14.00
(14.00 to 14.00)
14.00
(14.00 to 14.00)
14.91
(12.96 to 17.16)
A/INDO, Day 182 [N=33;39;33;10;10;9]
216.82
(162.03 to 290.14)
130.32
(107.30 to 158.26)
104.18
(86.95 to 124.82)
16.11
(11.73 to 22.13)
14.00
(14.00 to 14.00)
17.67
(12.08 to 25.86)
A/INDO, Day 385 [N=25;33;37;8;11;9]
166.64
(135.90 to 204.32)
108.59
(87.88 to 134.19)
82.26
(67.27 to 100.59)
15.27
(12.44 to 18.74)
14.91
(12.96 to 17.16)
16.33
(12.91 to 20.66)
A/VIET, Day 0 [N=36;36;40;7;10;11]
14.83
(13.89 to 15.84)
19.84
(16.82 to 23.40)
24.88
(20.75 to 29.85)
17.11
(10.47 to 27.95)
16.08
(13.05 to 19.82)
20.47
(14.82 to 28.26)
A/VIET, Day 42 [N=34;37;40;6;10;11]
68.18
(58.05 to 80.07)
71.15
(61.62 to 82.15)
65.25
(57.03 to 74.64)
17.69
(9.69 to 32.28)
19.87
(12.97 to 30.43)
28.14
(19.53 to 40.54)
A/VIET, Day 182 [N=33;39;33;10;10;9]
48.77
(36.56 to 65.06)
44.11
(36.19 to 53.77)
61.67
(51.38 to 74.01)
19.82
(12.22 to 32.14)
17.24
(13.56 to 21.90)
24.14
(14.29 to 40.78)
A/VIET, Day 385 [N=25;33;37;8;11;9]
59.83
(48.09 to 74.43)
38.62
(30.60 to 48.73)
47.73
(38.76 to 58.79)
14.00
(14.00 to 14.00)
18.07
(12.34 to 26.47)
35.42
(19.45 to 64.49)
16.Secondary Outcome
Title Number of Subjects Seropositive for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Hide Description [Not Specified]
Time Frame At Days 0 and 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Day 42 According-to-Protocol cohort for immunogenicity, that is, all evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0 and 42 time points.
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Virus Monovalent Vaccine 3-<9Y Group Influenza A (H5N1) Virus Monovalent Vaccine 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 36 37 40 7 10 11
Measure Type: Number
Unit of Measure: Subject
At Day 0 0 6 5 1 0 1
At Day 42 34 37 40 0 0 1
17.Secondary Outcome
Title Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.
Hide Description VRR for MN was defined as as the incidence rate of vaccinees with a 4-fold increase in post vaccination reciprocal titer relative to Day 0.
Time Frame At Day 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Day 42 According-to-Protocol cohort for immunogenicity, that is, all evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0 and 42 time points.
Arm/Group Title Influenza A (H5N1) Adjuvanted 6-<36M Group Influenza A (H5N1) Adjuvanted 3-<9Y Group Influenza A (H5N1) Adjuvanted 9-<18Y Group Placebo 6-<36M Group Placebo 3-<9Y Group Placebo 9-<18Y Group
Hide Arm/Group Description:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 34 37 40 6 11 11
Measure Type: Number
Unit of Measure: Subject
A/INDO [N=34;37;40;6;10;11] 34 37 39 0 0 0
A/VIET [N=34;36;40;6;10;11] 30 26 16 0 1 0
18.Secondary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms.
Hide Description Solicited local symptoms assessed were pain, redness and swelling. “Any” was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).
Time Frame During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, solely on subjects with results available/accessible.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 603 229
Measure Type: Number
Unit of Measure: Subject
Any pain 405 69
Grade 3 pain 25 4
Any redness 29 0
Grade 3 redness 1 0
Any swelling 41 1
Grade 3 swelling 1 0
19.Secondary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms.
Hide Description Solicited local symptoms assessed were pain and swelling. “Any” was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).
Time Frame During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Placebo/Placebo/ Influenza A (H5N1) Adjuvanted Group
Hide Arm/Group Description:
Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 154
Measure Type: Number
Unit of Measure: Subject
Any Pain 111
Grade 3 Pain 8
Any Redness 6
Grade 3 Redness 0
Any Swelling 5
Grade 3 Swelling 0
20.Secondary Outcome
Title Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.
Hide Description Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >= 39.0°C.
Time Frame During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, PInfluenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 294 122
Measure Type: Number
Unit of Measure: Subject
Any Drowsiness 101 29
Grade 3 Drowsiness 9 2
Related Drowsiness 81 21
Any Irritability/fussiness 128 40
Grade 3 Irritability/fussiness 10 2
Related Irritability/fussiness 111 33
Any Loss of appetite 79 29
Grade 3 Loss of appetite 8 4
Related Loss of appetite 63 20
Any Fever 59 21
Grade 3 Fever 14 5
Related Fever 41 14
21.Secondary Outcome
Title Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.
Hide Description Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >=39.0°C.
Time Frame During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Placebo/ Influenza A (H5N1) Adjuvanted Group
Hide Arm/Group Description:
Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: Subject
Any Drowsiness 23
Grade 3 Drowsiness 1
Related Drowsiness 17
Any Irritability/Fussiness 28
Grade 3 Irritability/Fussiness 1
Related Irritability/Fussiness 23
Any Loss of appetite 18
Grade 3 Loss of appetite 0
Related Loss of appetite 13
Any Fever 4
Grade 3 Fever 2
Related Fever 3
22.Secondary Outcome
Title Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.
Hide Description Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C.
Time Frame During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 309 107
Measure Type: Number
Unit of Measure: Subject
Any fatigue 89 19
Grade 3 fatigue 4 2
Related fatigue 77 16
Any gastrointestinal symptoms 43 18
Grade 3 gastrointestinal symptoms 4 2
Related gastrointestinal symptoms 27 11
Any headache 100 18
Grade 3 headache 8 3
Related headache 87 15
Any joint pain 50 9
Grade 3 joint pain 2 0
Related joint pain 43 8
Any muscle aches 123 17
Grade 3 muscle aches 7 1
Related muscle aches 114 14
Any shivering 25 7
Grade 3 shivering 2 1
Related shivering 19 5
Any sweating 25 4
Grade 3 sweating 2 0
Related sweating 22 1
Any fever 19 3
Grade 3 fever 5 1
Related fever 13 2
23.Secondary Outcome
Title Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.
Hide Description Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C.
Time Frame During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Placebo/Influenza A (H5N1) Adjuvanted Group
Hide Arm/Group Description:
Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: Subject
Any Fatigue 18
Grade 3 Fatigue 1
Related Fatigue 13
Any Gastrointestinal 7
Grade 3 Gastrointestinal 0
Related Gastrointestinal 5
Any Headache 24
Grade 3 Headache 1
Related Headache 20
Any Increased Sweating 5
Grade 3 Increased Sweating 0
Related Increased Sweating 3
Any Joint Pain 14
Grade 3 Joint Pain 0
Related Joint Pain 12
Any Muscle Aches 34
Grade 3 Muscle Aches 0
Related Muscle Aches 28
Any Shivering (Chills) 7
Grade 3 Shivering (Chills) 2
Related Shivering (Chills) 4
Any Fever 1
Grade 3 Fever 0
Related Fever 0
24.Secondary Outcome
Title Number of Subjects With Medically-attended Adverse Events (MAEs)
Hide Description MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.
Time Frame From Day 0 up to Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 607 231
Measure Type: Number
Unit of Measure: Subject
189 77
25.Secondary Outcome
Title Number of Subjects With Medically-attended Adverse Events (MAEs)
Hide Description MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.
Time Frame From Day U0 up to Day U385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Placebo/ Influenza A (H5N1) Adjuvanted Group
Hide Arm/Group Description:
Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 155
Measure Type: Number
Unit of Measure: Subject
36
26.Secondary Outcome
Title Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. “Any pIMD” was defined as at least one pIMD experienced by the study subject.
Time Frame From Day 0 up to Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 607 231
Measure Type: Number
Unit of Measure: Subject
1 1
27.Secondary Outcome
Title Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. “Any pIMD” was defined as at least one pIMD experienced by the study subject.
Time Frame From Day U0 to Day U385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Placebo/ Influenza A (H5N1) Adjuvanted Group
Hide Arm/Group Description:
Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 155
Measure Type: Number
Unit of Measure: Subject
0
28.Secondary Outcome
Title Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies
Hide Description [Not Specified]
Time Frame From Day 0 up to Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 607 231
Measure Type: Number
Unit of Measure: Subject
Subject(s) with any pregnancy 2 0
Subject(s) with related pregnancy 0 0
Spontaneous abortion 1 0
Healthy live birth 1 0
29.Secondary Outcome
Title Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies
Hide Description [Not Specified]
Time Frame From Day U0 to Day U385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Placebo/ Influenza A (H5N1) Adjuvanted Group
Hide Arm/Group Description:
Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 155
Measure Type: Number
Unit of Measure: Subject
0
30.Secondary Outcome
Title Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALAT) and Aspartate Aminotransferase (ASAT)
Hide Description Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame From Day 0 up to Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 606 231
Measure Type: Number
Unit of Measure: Subject
ALAT, PRE Unknown [N=606,231] 15 4
ALAT, PRE Below [N=606,231] 0 0
ALAT, PRE Normal [N=606,231] 586 221
ALAT, PRE Above [N=606,231] 5 6
ALAT, Day 42 Unknown [N=583,220] 17 4
ALAT, Day 42 Below [N=583,220] 0 0
ALAT, Day 42 Normal [N=583,220] 562 212
ALAT, Day 42 Above [N=583,220] 4 4
ALAT, Day 182 Unknown [N=304,110] 6 0
ALAT, Day 182 Below [N=304,110] 0 0
ALAT, Day 182 Normal [N=304,110] 289 110
ALAT, Day 182 Above [N=304,110] 9 0
ALAT, Day 385 Unknown [N=251,104] 5 0
ALAT, Day 385 Below [N=251,104] 0 0
ALAT, Day 385 Normal [N=251,104] 245 100
ALAT, Day 385 Above [N=251,104] 1 4
ASAT, PRE Unknown [N=606,231] 15 4
ASAT, PRE Below [N=606,231] 0 0
ASAT, PRE Normal [N=606,231] 577 219
ASAT, PRE Above [N=606,231] 14 8
ASAT, Day 42 Unknown [N=583,220] 19 4
ASAT, Day 42 Below [N=583,220] 0 0
ASAT, Day 42 Normal [N=583,220] 552 208
ASAT, Day 42 Above [N=583,220] 12 8
ASAT, Day 182 Unknown [N=304,110] 8 0
ASAT, Day 182 Below [N=304,110] 0 0
ASAT, Day 182 Normal [N=304,110] 284 108
ASAT, Day 182 Above [N=304,110] 12 2
ASAT, Day 385 Unknown [N=251,104] 7 0
ASAT, Day 385 Below [N=251,104] 0 0
ASAT, Day 385 Normal [N=251,104] 240 100
ASAT, Day 385 Above [N=251,104] 4 4
31.Secondary Outcome
Title Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Total Bilirubin (T-BIL) and Bilirubin Conjugated/Direct (BIL-C/D)
Hide Description Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame From Day 0 up to Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 606 231
Measure Type: Number
Unit of Measure: Subject
T-BIL, PRE Unknown [N=606,231] 15 4
T-BIL, PRE Below [N=606,231] 0 0
T-BIL, PRE Normal [N=606,231] 587 224
T-BIL, PRE Above [N=606,231] 4 3
T-BIL, Day 42 Unknown [N=583,220] 16 4
T-BIL, Day 42 Below [N=583,220] 0 0
T-BIL, Day 42 Normal [N=583,220] 558 214
T-BIL, Day 42 Above [N=583,220] 9 2
T-BIL, Day 182 Unknown [N=304,110] 6 0
T-BIL, Day 182 Below [N=304,110] 0 0
T-BIL, Day 182 Normal [N=304,110] 296 110
T-BIL, Day 182 Above [N=304,110] 2 0
T-BIL, Day 385 Unknown [N=251,104] 7 1
T-BIL, Day 385 Below [N=251,104] 0 0
T-BIL, Day 385 Normal [N=251,104] 240 102
T-BIL, Day 385 Above [N=251,104] 4 1
BIL-C/D, PRE Unknown [N=606,231] 15 4
BIL-C/D, PRE Below [N=606,231] 0 0
BIL-C/D, PRE Normal [N=606,231] 591 226
BIL-C/D, PRE Above [N=606,231] 0 1
BIL-C/D, Day 42 Unknown [N=583,220] 16 4
BIL-C/D, Day 42 Below [N=583,220] 0 0
BIL-C/D, Day 42 Normal [N=583,220] 558 214
BIL-C/D, Day 42 Above [N=583,220] 9 2
BIL-C/D, Day 182 Unknown [N=304,110] 7 0
BIL-C/D, Day 182 Below [N=304,110] 0 0
BIL-C/D, Day 182 Normal [N=304,110] 297 110
BIL-C/D, Day 182 Above [N=304,110] 0 0
BIL-C/D, Day 385 Unknown [N=251,104] 8 1
BIL-C/D, Day 385 Below [N=251,104] 0 0
BIL-C/D, Day 385 Normal [N=251,104] 240 103
BIL-C/D, Day 385 Above [N=251,104] 3 0
32.Secondary Outcome
Title Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN)
Hide Description Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame From Day 0 up to Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&amp;lt;12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&amp;gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 607 231
Measure Type: Number
Unit of Measure: Subject
CREA, PRE Unknown [N=606,231] 15 4
CREA, PRE Below [N=606, 231] 142 61
CREA, PRE Within [N=606, 231] 447 165
CREA, PRE Above [N=606, 231] 2 1
CREA, Day 42 Unknown [N=583,220] 17 4
CREA, Day 42 Below [N=583,220] 130 48
CREA, Day 42 Within [N=583,220] 432 166
CREA, Day 42 Above [N=583,220] 4 2
CREA, Day 182 Unknown [N=304,110] 6 1
CREA, Day 182 Below [N=304,110] 66 26
CREA, Day 182 Within [N=304,110] 231 83
CREA, Day 182 Above [N=304,110] 1 0
CREA, Day 385 Unknown [N=251,104] 6 0
CREA, Day 385 Below [N=251,104] 51 24
CREA, Day 385 Within [N=251,104] 191 80
CREA, Day 385 Above [N=251,104] 3 0
BUN, PRE Unknown [N=606,231] 15 4
BUN, PRE Below [N=606,231] 13 4
BUN, PRE Within [N=606,231] 553 218
BUN, PRE Above [N=606,231] 25 5
BUN, Day 42 Unknown [N=583,220] 17 4
BUN, Day 42 Below [N=583,220] 11 3
BUN, Day 42 Within [N=583,220] 531 209
BUN, Day 42 Above [N=583,220] 24 4
BUN, Day 182 Unknown [N=304,110] 6 0
BUN, Day 182 Below [N=304,110] 8 2
BUN, Day 182 Within [N=304,110] 281 105
BUN, Day 182 Above [N=304,110] 9 3
BUN, Day 385 Unknown [N=251,104] 7 0
BUN, Day 385 Below [N=251,104] 3 2
BUN, Day 385 Within [N=251,104] 237 100
BUN, Day 385 Above [N=251,104] 4 2
33.Secondary Outcome
Title Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Basophils (BAS) and Eosinophils (EOS)
Hide Description Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame From Day 0 up to Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 607 231
Measure Type: Number
Unit of Measure: Subject
BAS, PRE Unknown [N=606,231] 29 12
BAS, PRE Below [N=606,231] 0 0
BAS, PRE Within [N=606,231] 576 219
BAS, PRE Above [N=606,231] 1 0
BAS, Day 42 Unknown [N=583,220] 34 13
BAS, Day 42 Below [N=583,220] 0 0
BAS, Day 42 Within [N=583,220] 549 207
BAS, Day 42 Above [N=583,220] 0 0
BAS, Day 182 Unknown [N=304,110] 17 2
BAS, Day 182 Below [N=304,110] 0 0
BAS, Day 182 Within [N=304,110] 287 108
BAS, Day 182 Above [N=304,110] 0 0
BAS, Day 385 Unknown [N=251,104] 6 3
BAS, Day 385 Below [N=251,104] 0 0
BAS, Day 385 Within [N=251,104] 245 101
BAS, Day 385 Above [N=251,104] 0 0
EOS, PRE Unknown [N=606,231] 29 12
EOS, PRE Below [N=606,231] 68 19
EOS, PRE Within [N=606,231] 473 187
EOS, PRE Above [N=606,231] 36 13
EOS, Day 42 Unknown [N=583,220] 34 13
EOS, Day 42 Below [N=583,220] 49 15
EOS, Day 42 Within [N=583,220] 452 175
EOS, Day 42 Above [N=583,220] 48 17
EOS, Day 182 Unknown [N=304,110] 17 2
EOS, Day 182 Below [N=304,110] 33 11
EOS, Day 182 Within [N=304,110] 237 85
EOS, Day 182 Above [N=304,110] 17 12
EOS, Day 385 Unknown [N=251,104] 6 3
EOS, Day 385 Below [N=251,104] 32 17
EOS, Day 385 Within [N=251,104] 198 77
EOS, Day 385 Above [N=251,104] 15 7
34.Secondary Outcome
Title Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Haematocrit (Hcr) and Haemoglobin (Hgb)
Hide Description Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame From Day 0 up to Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&amp;lt;12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&amp;gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 607 231
Measure Type: Number
Unit of Measure: Subject
Hcr, PRE Unknown [N=606,231] 26 10
Hcr, PRE Below [N=606,231] 53 21
Hcr, PRE Within [N=606,231] 480 181
Hcr, PRE Above [N=606,231] 47 19
Hcr, Day 42 Unknown [N=583,220] 19 7
Hcr, Day 42 Below [N=583,220] 45 13
Hcr, Day 42 Within [N=583,220] 477 178
Hcr, Day 42 Above [N=583,220] 42 22
Hcr, Day 182 Unknown [N=304,110] 12 2
Hcr, Day 182 Below [N=304,110] 38 7
Hcr, Day 182 Within [N=304,110] 238 91
Hcr, Day 182 Above [N=304,110] 16 10
Hcr, Day 385 Unknown [N=251,104] 5 3
Hcr, Day 385 Below [N=251,104] 18 12
Hcr, Day 385 Within [N=251,104] 215 85
Hcr, Day 385 Above [N=251,104] 13 4
Hgb, PRE Unknown [N=606,231] 26 10
Hgb, PRE Below [N=606,231] 61 26
Hgb, PRE Within [N=606,231] 497 182
Hgb, PRE Above [N=606,231] 22 13
Hgb, Day 42 Unknown [N=583,220] 19 8
Hgb, Day 42 Below [N=583,220] 69 19
Hgb, Day 42 Within [N=583,220] 476 185
Hgb, Day 42 Above [N=583,220] 19 8
Hgb, Day 182 Unknown [N=304,110] 11 2
Hgb, Day 182 Below [N=304,110] 42 16
Hgb, Day 182 Within [N=304,110] 241 89
Hgb, Day 182 Above [N=304,110] 10 3
Hgb, Day 385 Unknown [N=251,104] 5 3
Hbg, Day 385 Below [N=251,104] 27 15
Hbg, Day 385 Within [N=251,104] 210 84
Hbg, Day 385 Above [N=251,104] 9 2
35.Secondary Outcome
Title Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Neutrophils (NEU) and Platelets (PLA)
Hide Description Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame From Day 0 up to Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 607 231
Measure Type: Number
Unit of Measure: Subject
NEU, PRE Unknown [N=606,231] 29 12
NEU, PRE Below [N=606,231] 26 10
NEU, PRE Within [N=606,231] 534 202
NEU, PRE Above [N=606,231] 17 7
NEU, Day 42 Unknown [N=583,220] 34 13
NEU, Day 42 Below [N=583,220] 29 8
NEU, Day 42 Within [N=583,220] 505 189
NEU, Day 42 Above [N=583,220] 15 10
NEU, Day 182 Unknown [N=304,110] 17 2
NEU, Day 182 Below [N=304,110] 14 3
NEU, Day 182 Within [N=304,110] 266 105
NEU, Day 182 Above [N=304,110] 7 0
NEU, Day 385 Unknown [N=251,104] 6 3
NEU, Day 385 Below [N=251,104] 12 3
NEU, Day 385 Within [N=251,104] 227 96
NEU, Day 385 Above [N=251,104] 6 2
PLA, PRE Unknown [N=606,231] 35 17
PLA, PRE Below [N=606,231] 3 0
PLA, PRE Within [N=606,231] 518 187
PLA, PRE Above [N=606,231] 50 27
PLA, Day 42 Unknown [N=583,220] 32 12
PLA, Day 42 Below [N=583,220] 1 0
PLA, Day 42 Within [N=583,220] 500 184
PLA, Day 42 Above [N=583,220] 50 24
PLA, Day 182 Unknown [N=304,110] 20 5
PLA, Day 182 Below [N=304,110] 0 0
PLA, Day 182 Within [N=304,110] 260 96
PLA, Day 182 Above [N=304,110] 24 9
PLA, Day 385 Unknown [N=251,104] 8 8
PLA, Day 385 Below [N=251,104] 1 0
PLA, Day 385 Within [N=251,104] 234 94
PLA, Day 385 Above [N=251,104] 8 2
36.Secondary Outcome
Title Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Lymphocytes (LYM) and Monocytes (MON)
Hide Description Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame From Day 0 up to Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 607 231
Measure Type: Number
Unit of Measure: Subject
LYM, PRE Unknown [N=606,231] 29 12
LYM, PRE Below [N=606,231] 7 1
LYM, PRE Within [N=606,231] 441 161
LYM, PRE Above [N=606,231] 129 57
LYM, Day 42 Unknown [N=583,220] 34 13
LYM, Day 42 Below [N=583,220] 6 2
LYM, Day 42 Within [N=583,220] 446 162
LYM, Day 42 Above [N=583,220] 97 43
LYM, Day 182 Unknown [N=304,110] 17 2
LYM, Day 182 Below [N=304,110] 0 1
LYM, Day 182 Within [N=304,110] 235 93
LYM, Day 182 Above [N=304,110] 52 14
LYM, Day 385 Unknown [N=251,104] 6 3
LYM, Day 385 Below [N=251,104] 0 0
LYM, Day 385 Within [N=251,104] 223 86
LYM, Day 385 Above [N=251,104] 22 15
MON, PRE Unknown [N=606,231] 29 12
MON, PRE Below [N=606,231] 94 46
MON, PRE Within [N=606,231] 480 170
MON, PRE Above [N=606,231] 3 3
MON, Day 42 Unknown [N=583,220] 34 13
MON, Day 42 Below [N=583,220] 110 37
MON, Day 42 Within [N=583,220] 434 167
MON, Day 42 Above [N=583,220] 5 3
MON, Day 182 Unknown [N=304,110] 17 2
MON, Day 182 Below [N=304,110] 61 20
MON, Day 182 Within [N=304,110] 221 88
MON, Day 182 Above [N=304,110] 5 0
MON, Day 385 Unknown [N=251,104] 6 3
MON, Day 385 Below [N=251,104] 31 18
MON, Day 385 Within [N=251,104] 211 83
MON, Day 385 Above [N=251,104] 3 0
37.Secondary Outcome
Title Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Red and White Blood Cells (RBC and WBC)
Hide Description Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame From Day 0 up to Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 607 231
Measure Type: Number
Unit of Measure: Subject
RBC, PRE Unknown [N=606,231] 26 10
RBC, PRE Below [N=606,231] 25 4
RBC, PRE Within [N=606,231] 504 198
RBC, PRE Above [N=606,231] 51 19
RBC, Day 42 Unknown [N=583,220] 19 8
RBC, Day 42 Below [N=583,220] 21 6
RBC, Day 42 Within [N=583,220] 496 189
RBC, Day 42 Above [N=583,220] 47 17
RBC, Day 182 Unknown [N=304,110] 11 2
RBC, Day 182 Below [N=304,110] 13 5
RBC, Day 182 Within [N=304,110] 266 93
RBC, Day 182 Above [N=304,110] 14 10
RBC, Day 385 Unknown [N=251,104] 5 3
RBC, Day 385 Below [N=251,104] 8 2
RBC, Day 385 Within [N=251,104] 214 90
RBC, Day 385 Above [N=251,104] 24 9
WBC, PRE Unknown [N=606,231] 29 12
WBC, PRE Below [N=606,231] 27 9
WBC, PRE Within [N=606,231] 543 207
WBC, PRE Above [N=606,231] 7 3
WBC, Day 42 Unknown [N=583,220] 34 13
WBC, Day 42 Below [N=583,220] 38 8
WBC, Day 42 Within [N=583,220] 508 198
WBC, Day 42 Above [N=583,220] 3 1
WBC, Day 182 Unknown [N=304,110] 17 2
WBC, Day 182 Below [N=304,110] 21 7
WBC, Day 182 Within [N=304,110] 264 101
WBC, Day 182 Above [N=304,110] 2 0
WBC, Day 385 Unknown [N=251,104] 6 3
WBC, Day 385 Below [N=251,104] 15 6
WBC, Day 385 Within [N=251,104] 230 94
WBC, Day 385 Above [N=251,104] 0 1
38.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Hide Description An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame During the 21-day (Days 0-20) post-vaccination period following Dose 1 of vaccine/placebo
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, PInfluenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 607 231
Measure Type: Number
Unit of Measure: Subject
153 63
39.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Hide Description An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame During the 21-day (Days 21-41) post-vaccination period following Dose 2 of vaccine/placebo
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and PInfluenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 593 224
Measure Type: Number
Unit of Measure: Subject
135 54
40.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Hide Description An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame During the 42-day (Days 0-41) post-vaccination period following Dose 1 of vaccine/placebo
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 607 231
Measure Type: Number
Unit of Measure: Subject
243 97
41.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs)
Hide Description A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time Frame From Day 0 up to Day 385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group
Hide Arm/Group Description:
This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Overall Number of Participants Analyzed 607 231
Measure Type: Number
Unit of Measure: Subject
8 4
42.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Hide Description An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame During the 21-day (Days U0-U20) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group
Hide Arm/Group Description:
Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 155
Measure Type: Number
Unit of Measure: Subject
21
43.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Hide Description An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame During the 21-day (Days U21-U41) post-vaccination period following Dose 2 of Influenza A (H5N1) Virus monovalent vaccine
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Placebo/Influenza A (H5N1) Adjuvanted Group
Hide Arm/Group Description:
Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 155
Measure Type: Number
Unit of Measure: Subject
27
44.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Hide Description An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.
Time Frame During the 42-day (Days U0-U41) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group
Hide Arm/Group Description:
Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 155
Measure Type: Number
Unit of Measure: Subject
41
45.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs)
Hide Description A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time Frame From Day U0 up to Day U385
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Placebo/Influenza A (H5N1) Adjuvanted Group
Hide Arm/Group Description:
Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 155
Measure Type: Number
Unit of Measure: Subject
2
Time Frame Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration.
Adverse Event Reporting Description For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
 
Arm/Group Title Influenza A (H5N1) Adjuvanted Group Placebo Group Placebo/Influenza A (H5N1) Adjuvanted Group
Hide Arm/Group Description This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3≤9Y and Influenza A (H5N1) adjuvanted 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm). Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6≤36M, Placebo 3≤9Y or Placebo 9≤18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6≤36M, Placebo 3≤9Y and Placebo 9≤18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
All-Cause Mortality
Influenza A (H5N1) Adjuvanted Group Placebo Group Placebo/Influenza A (H5N1) Adjuvanted Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Influenza A (H5N1) Adjuvanted Group Placebo Group Placebo/Influenza A (H5N1) Adjuvanted Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/607 (1.32%)      4/231 (1.73%)      2/155 (1.29%)    
Blood and lymphatic system disorders       
Lymphadenitis * 1 [1]  0/607 (0.00%)  1/231 (0.43%)  0/155 (0.00%)  0
Gastrointestinal disorders       
Inguinal hernia * 1 [1]  1/607 (0.16%)  0/231 (0.00%)  0/155 (0.00%)  0
Infections and infestations       
Infectious mononucleosis * 1 [1]  2/607 (0.33%)  0/231 (0.00%)  0/155 (0.00%)  0
Influenza * 1 [1]  1/607 (0.16%)  0/231 (0.00%)  0/155 (0.00%)  0
Pneumonia * 1 [1]  1/607 (0.16%)  0/231 (0.00%)  0/155 (0.00%)  0
Upper respiratory tract infection * 1 [1]  1/607 (0.16%)  0/231 (0.00%)  0/155 (0.00%)  0
Scarlet fever * 1 [2]  0/607 (0.00%)  0/231 (0.00%)  1/155 (0.65%) 
Injury, poisoning and procedural complications       
Skeletal injury * 1 [1]  1/607 (0.16%)  0/231 (0.00%)  0/155 (0.00%)  0
Wound * 1 [1]  0/607 (0.00%)  0/231 (0.00%)  1/155 (0.65%) 
Metabolism and nutrition disorders       
Dehydration * 1 [1]  1/607 (0.16%)  0/231 (0.00%)  0/155 (0.00%)  0
Type 1 diabetes mellitus * 1 [1]  0/607 (0.00%)  1/231 (0.43%)  0/155 (0.00%)  0
Nervous system disorders       
Febrile convulsion * 1 [1]  1/607 (0.16%)  0/231 (0.00%)  0/155 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous * 1 [1]  1/607 (0.16%)  0/231 (0.00%)  0/155 (0.00%)  0
Psychiatric disorders       
Suicidal ideation * 1 [1]  0/607 (0.00%)  1/231 (0.43%)  0/155 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma * 1 [1]  0/607 (0.00%)  1/231 (0.43%)  0/155 (0.00%)  0
Bronchial hyperreactivity * 1 [3]  1/607 (0.16%)  0/231 (0.00%)  0/155 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[1]
SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
[2]
SAE assesed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
[3]
SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group..
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Influenza A (H5N1) Adjuvanted Group Placebo Group Placebo/Influenza A (H5N1) Adjuvanted Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   502/607 (82.70%)      189/231 (81.82%)      124/155 (80.00%)    
Gastrointestinal disorders       
Diarrhoea * 1 [1]  13/607 (2.14%)  12/231 (5.19%)  3/155 (1.94%) 
General disorders       
Pain  1 [2]  405/603 (67.16%)  69/229 (30.13%)  111/154 (72.08%) 
Swelling  1 [2]  41/603 (6.80%)  1/229 (0.44%)  5/154 (3.25%) 
Drowsiness  1 [3]  101/294 (34.35%)  29/122 (23.77%)  23/79 (29.11%) 
Irritability/fussiness  1 [3]  128/294 (43.54%)  40/122 (32.79%)  28/79 (35.44%) 
Loss of appetite  1 [3]  79/294 (26.87%)  29/122 (23.77%)  18/79 (22.78%) 
Fever (axillary temperature >= 38.0°C)  1 [3]  59/294 (20.07%)  21/122 (17.21%)  4/79 (5.06%) 
Fatigue  1 [4]  89/309 (28.80%)  19/107 (17.76%)  18/75 (24.00%) 
Gastrointestinal disorders  1 [4]  43/309 (13.92%)  18/107 (16.82%)  7/75 (9.33%) 
Headache  1 [4]  100/309 (32.36%)  18/107 (16.82%)  24/75 (32.00%) 
Joint pain at other location  1 [4]  50/309 (16.18%)  9/107 (8.41%)  14/75 (18.67%) 
Muscle aches  1 [4]  123/309 (39.81%)  17/107 (15.89%)  34/75 (45.33%) 
Shivering  1 [4]  25/309 (8.09%)  7/107 (6.54%)  7/75 (9.33%) 
Sweating  1 [4]  25/309 (8.09%)  4/107 (3.74%)  5/75 (6.67%) 
Fever (axillary temperature >= 38.0°C)  1 [4]  19/309 (6.15%)  3/107 (2.80%)  1/75 (1.33%) 
Infections and infestations       
Nasopharyngitis * 1 [1]  29/607 (4.78%)  18/231 (7.79%)  10/155 (6.45%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1 [1]  36/607 (5.93%)  17/231 (7.36%)  9/155 (5.81%) 
Rhinorrhoea * 1 [1]  27/607 (4.45%)  13/231 (5.63%)  3/155 (1.94%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[1]
AE assesed within the 42-day post-vaccination period following the first vaccination during Day 0 - Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
[2]
AE assesed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
[3]
AE assesed in children less than 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
[4]
AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01310413     History of Changes
Other Study ID Numbers: 114464
First Submitted: February 24, 2011
First Posted: March 8, 2011
Results First Submitted: January 9, 2014
Results First Posted: March 31, 2014
Last Update Posted: October 22, 2018