Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00976820
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
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: GSK2340274A
Biological: GSK2340273A
Enrollment 323
Recruitment Details  
Pre-assignment Details Out of the 323 subjects originally enrolled in the study, 1 subject was not included in the Total Vaccinated Cohort.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh [for children under (<) 12 months of age]. The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Period Title: Overall Study
Started 67 128 64 63
Completed 59 108 60 56
Not Completed 8 20 4 7
Reason Not Completed
Lost to Follow-up             5             16             2             3
Poor Compliance. Numerous Visits Booked             1             0             1             0
Withdrawal by Subject             2             4             1             4
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group Total
Hide Arm/Group Description Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). Total of all reporting groups
Overall Number of Baseline Participants 67 128 64 63 322
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 67 participants 128 participants 64 participants 63 participants 322 participants
53.6  (31.6) 47.4  (28.6) 50.3  (29.0) 54.4  (30.4) 50.6  (29.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 128 participants 64 participants 63 participants 322 participants
Female
27
  40.3%
58
  45.3%
33
  51.6%
30
  47.6%
148
  46.0%
Male
40
  59.7%
70
  54.7%
31
  48.4%
33
  52.4%
174
  54.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 128 participants 64 participants 63 participants 322 participants
African heritage/African American
1
   1.5%
7
   5.5%
1
   1.6%
1
   1.6%
10
   3.1%
American Indian or Alaskan native
1
   1.5%
6
   4.7%
1
   1.6%
2
   3.2%
10
   3.1%
Asian - Central/South Asian heritage
14
  20.9%
16
  12.5%
16
  25.0%
14
  22.2%
60
  18.6%
Asian - East Asian heritage
2
   3.0%
4
   3.1%
0
   0.0%
2
   3.2%
8
   2.5%
Asian - South East Asian heritage
3
   4.5%
1
   0.8%
2
   3.1%
2
   3.2%
8
   2.5%
White - Arabic/North African heritage
0
   0.0%
3
   2.3%
0
   0.0%
1
   1.6%
4
   1.2%
White - Caucasian/European heritage
46
  68.7%
86
  67.2%
44
  68.8%
38
  60.3%
214
  66.5%
Not specified
0
   0.0%
5
   3.9%
0
   0.0%
3
   4.8%
8
   2.5%
1.Primary Outcome
Title Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 63 55 58 60
Measure Type: Count of Participants
Unit of Measure: Participants
60
  95.2%
53
  96.4%
45
  77.6%
36
  60.0%
2.Primary Outcome
Title Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain – First Analysis
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 57 47 55 57
Measure Type: Count of Participants
Unit of Measure: Participants
54
  94.7%
45
  95.7%
41
  74.5%
34
  59.6%
3.Primary Outcome
Title Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain – Second Analysis
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 59 101 54 57
Measure Type: Count of Participants
Unit of Measure: Participants
56
  94.9%
98
  97.0%
41
  75.9%
34
  59.6%
4.Primary Outcome
Title Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain – First Analysis
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 43 40 46 44
Measure Type: Count of Participants
Unit of Measure: Participants
43
 100.0%
39
  97.5%
46
 100.0%
38
  86.4%
5.Primary Outcome
Title Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain – Second Analysis
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 44 84 46 44
Measure Type: Count of Participants
Unit of Measure: Participants
44
 100.0%
83
  98.8%
46
 100.0%
38
  86.4%
6.Primary Outcome
Title Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain – Preliminary Analysis
Hide Description A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame At Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort at Day 21, which included all subjects who received at least 1 study vaccination.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 66 59 61 62
Measure Type: Count of Participants
Unit of Measure: Participants
13
  19.7%
3
   5.1%
12
  19.7%
15
  24.2%
7.Primary Outcome
Title Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Hide Description A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort at Day 21, which included all subjects who received at least 1 study vaccination.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 63 56 59 60
Measure Type: Count of Participants
Unit of Measure: Participants
62
  98.4%
55
  98.2%
46
  78.0%
39
  65.0%
8.Primary Outcome
Title Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain – First Analysis
Hide Description A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame At Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 57 49 55 58
Measure Type: Count of Participants
Unit of Measure: Participants
12
  21.1%
2
   4.1%
12
  21.8%
14
  24.1%
9.Primary Outcome
Title Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain – First Analysis
Hide Description A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 57 49 55 57
Measure Type: Count of Participants
Unit of Measure: Participants
56
  98.2%
48
  98.0%
42
  76.4%
37
  64.9%
10.Primary Outcome
Title Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain – Second Analysis
Hide Description A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame At Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 59 102 54 58
Measure Type: Count of Participants
Unit of Measure: Participants
12
  20.3%
24
  23.5%
12
  22.2%
14
  24.1%
11.Primary Outcome
Title Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain – Second Analysis
Hide Description A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 59 103 54 57
Measure Type: Count of Participants
Unit of Measure: Participants
58
  98.3%
102
  99.0%
42
  77.8%
37
  64.9%
12.Primary Outcome
Title Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain – First Analysis
Hide Description A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame At Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 43 40 46 44
Measure Type: Count of Participants
Unit of Measure: Participants
8
  18.6%
1
   2.5%
9
  19.6%
9
  20.5%
13.Primary Outcome
Title Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain – First Analysis
Hide Description A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 43 42 46 44
Measure Type: Count of Participants
Unit of Measure: Participants
43
 100.0%
42
 100.0%
46
 100.0%
41
  93.2%
14.Primary Outcome
Title Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain – Second Analysis
Hide Description A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame At Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 44 84 46 44
Measure Type: Count of Participants
Unit of Measure: Participants
8
  18.2%
20
  23.8%
9
  19.6%
9
  20.5%
15.Primary Outcome
Title Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain – Second Analysis
Hide Description A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 44 87 46 44
Measure Type: Count of Participants
Unit of Measure: Participants
44
 100.0%
87
 100.0%
46
 100.0%
41
  93.2%
16.Primary Outcome
Title Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Hide Description SCF 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 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 63 55 58 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold change
38.6
(28.8 to 51.8)
39.2
(29.2 to 52.5)
14.4
(10.2 to 20.4)
7.8
(5.6 to 11.0)
17.Primary Outcome
Title Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Hide Description SCF 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 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 57 47 55 57
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold change
35.9
(26.4 to 49.0)
40.8
(29.7 to 56.2)
13.2
(9.2 to 18.8)
7.6
(5.4 to 10.6)
18.Primary Outcome
Title Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Hide Description SCF 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 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 59 101 54 57
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold change
36.2
(26.8 to 48.9)
33.6
(27.3 to 41.3)
13.8
(9.7 to 19.6)
7.6
(5.4 to 10.6)
19.Primary Outcome
Title Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Hide Description SCF 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 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 43 40 46 44
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold change
155.3
(105.7 to 228.2)
217.2
(163.9 to 287.9)
44.2
(30.6 to 63.9)
24.1
(15.9 to 36.5)
20.Primary Outcome
Title Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Hide Description SCF 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 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 44 84 46 44
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold change
157.1
(107.8 to 228.9)
151.6
(114.0 to 201.6)
44.2
(30.6 to 63.9)
24.1
(15.9 to 36.5)
21.Secondary Outcome
Title Number of Seropositive Subjects for HI Antibodies - Preliminary Analysis
Hide Description A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time Frame At Day 0 (PRE) and at Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 66 59 61 62
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/CAL/7/09, PRE Number Analyzed 66 participants 59 participants 61 participants 62 participants
17
  25.8%
4
   6.8%
13
  21.3%
15
  24.2%
Flu A/CAL/7/09, D21 Number Analyzed 63 participants 56 participants 59 participants 60 participants
63
 100.0%
56
 100.0%
57
  96.6%
56
  93.3%
22.Secondary Outcome
Title Number of Seropositive Subjects for HI Antibodies - First Analysis
Hide Description A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time Frame At Day 0 (PRE) and at Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 57 49 55 58
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/CAL/7/09, PRE Number Analyzed 57 participants 49 participants 55 participants 58 participants
15
  26.3%
3
   6.1%
13
  23.6%
14
  24.1%
Flu A/CAL/7/09, D21 Number Analyzed 57 participants 49 participants 55 participants 57 participants
57
 100.0%
49
 100.0%
53
  96.4%
54
  94.7%
23.Secondary Outcome
Title Number of Seropositive Subjects for HI Antibodies - Second Analysis
Hide Description A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time Frame At Day 0 (PRE) and at Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 59 103 54 58
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/CAL/7/09, PRE Number Analyzed 59 participants 102 participants 54 participants 58 participants
15
  25.4%
27
  26.5%
13
  24.1%
14
  24.1%
Flu A/CAL/7/09, D21 Number Analyzed 59 participants 103 participants 54 participants 57 participants
59
 100.0%
103
 100.0%
53
  98.1%
54
  94.7%
24.Secondary Outcome
Title Number of Seropositive Subjects for HI Antibodies - First Analysis
Hide Description A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time Frame At Day 0 (PRE) and at Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 43 42 46 44
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/CAL/7/09, PRE Number Analyzed 43 participants 40 participants 46 participants 44 participants
10
  23.3%
2
   5.0%
10
  21.7%
9
  20.5%
Flu A/CAL/7/09, D42 Number Analyzed 43 participants 42 participants 46 participants 44 participants
43
 100.0%
42
 100.0%
46
 100.0%
44
 100.0%
25.Secondary Outcome
Title Number of Seropositive Subjects for HI Antibodies - Second Analysis
Hide Description A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time Frame At Day 0 (PRE) and at Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 44 87 46 44
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/CAL/7/09, PRE Number Analyzed 44 participants 84 participants 46 participants 44 participants
10
  22.7%
23
  27.4%
10
  21.7%
9
  20.5%
Flu A/CAL/7/09, D42 Number Analyzed 44 participants 87 participants 46 participants 44 participants
44
 100.0%
87
 100.0%
46
 100.0%
44
 100.0%
26.Secondary Outcome
Title Number of Seropositive Subjects for HI Antibodies
Hide Description A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time Frame At Day 0 (PRE) and at Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 54 84 47 52
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/CAL/7/09, PRE Number Analyzed 54 participants 82 participants 47 participants 52 participants
13
  24.1%
18
  22.0%
13
  27.7%
12
  23.1%
Flu A/CAL/7/09, D182 Number Analyzed 54 participants 84 participants 47 participants 52 participants
54
 100.0%
84
 100.0%
45
  95.7%
50
  96.2%
27.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Hide Description Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame At Day 0 (PRE) and at Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 66 59 61 62
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/CAL/7/09, PRE Number Analyzed 66 participants 59 participants 61 participants 62 participants
10.3
(7.4 to 14.5)
6.2
(4.9 to 7.7)
9.8
(6.9 to 13.9)
10.9
(7.6 to 15.7)
Flu A/CAL/7/09, D21 Number Analyzed 63 participants 56 participants 59 participants 60 participants
387.9
(286.7 to 524.8)
253.0
(185.8 to 344.4)
141.4
(90.8 to 220.1)
82.7
(52.9 to 129.5)
28.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Hide Description Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame At Day 0 (PRE) and at Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 57 49 55 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/CAL/7/09, PRE Number Analyzed 57 participants 49 participants 55 participants 58 participants
10.8
(7.4 to 15.6)
6.1
(4.7 to 7.8)
10.5
(7.2 to 15.5)
10.9
(7.5 to 15.8)
Flu A/CAL/7/09, D21 Number Analyzed 57 participants 49 participants 55 participants 57 participants
386.4
(280.3 to 532.6)
270.1
(194.2 to 375.5)
138.4
(86.3 to 222.0)
83.4
(52.9 to 131.4)
29.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Hide Description Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame At Day 0 (PRE) and at Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 59 103 54 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/CAL/7/09, PRE Number Analyzed 59 participants 102 participants 54 participants 58 participants
10.5
(7.3 to 15.1)
10.8
(8.2 to 14.3)
10.7
(7.2 to 15.8)
10.9
(7.5 to 15.8)
Flu A/CAL/7/09, D21 Number Analyzed 59 participants 103 participants 54 participants 57 participants
379.4
(277.9 to 518.0)
377.3
(299.6 to 475.3)
147.2
(92.4 to 234.3)
83.4
(52.9 to 131.4)
30.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Hide Description Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame At Day 0 (PRE) and at Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 43 42 46 44
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/CAL/7/09, PRE Number Analyzed 43 participants 40 participants 46 participants 44 participants
9.3
(6.4 to 13.5)
5.7
(4.6 to 7.1)
9.3
(6.4 to 13.6)
9.5
(6.4 to 14.0)
Flu A/CAL/7/09, D42 Number Analyzed 43 participants 42 participants 46 participants 44 participants
1444.4
(1146.0 to 1820.6)
1238.5
(1050.2 to 1460.5)
413.5
(296.6 to 576.4)
228.0
(156.9 to 331.3)
31.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Hide Description Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame At Day 0 (PRE) and at Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 44 87 46 44
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/CAL/7/09, PRE Number Analyzed 44 participants 84 participants 46 participants 44 participants
9.2
(6.3 to 13.2)
11.1
(8.2 to 15.1)
9.3
(6.4 to 13.6)
9.5
(6.4 to 14.0)
Flu A/CAL/7/09, D42 Number Analyzed 44 participants 87 participants 46 participants 44 participants
1440.5
(1149.0 to 1805.8)
1671.6
(1471.8 to 1898.4)
413.5
(296.6 to 576.4)
228.0
(156.9 to 331.3)
32.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain
Hide Description Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame At Day 0 (PRE) and at Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 54 84 47 52
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/CAL/7/09, PRE Number Analyzed 54 participants 82 participants 47 participants 52 participants
9.6
(6.8 to 13.5)
10.0
(7.3 to 13.6)
11.9
(7.7 to 18.6)
10.6
(7.2 to 15.7)
Flu A/CAL/7/09, D182 Number Analyzed 54 participants 84 participants 47 participants 52 participants
296.2
(230.5 to 380.8)
267.9
(219.5 to 327.0)
122.7
(86.4 to 174.3)
82.8
(59.5 to 115.2)
33.Secondary Outcome
Title Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time Frame At Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 54 82 47 52
Measure Type: Count of Participants
Unit of Measure: Participants
50
  92.6%
78
  95.1%
35
  74.5%
34
  65.4%
34.Secondary Outcome
Title Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain
Hide Description A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame At Day 0 (PRE) and at Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 54 84 47 52
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/CAL/7/09, PRE Number Analyzed 54 participants 82 participants 47 participants 52 participants
10
  18.5%
16
  19.5%
12
  25.5%
12
  23.1%
Flu A/CAL/7/09, D182 Number Analyzed 54 participants 84 participants 47 participants 52 participants
53
  98.1%
84
 100.0%
43
  91.5%
43
  82.7%
35.Secondary Outcome
Title Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain
Hide Description SCF 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 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 54 82 47 52
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold change
31.0
(22.7 to 42.4)
26.6
(20.6 to 34.3)
10.3
(7.1 to 14.8)
7.8
(5.5 to 10.9)
36.Secondary Outcome
Title Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
Hide Description A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Time Frame At Day 0 (PRE) and at Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 52 84 44 55
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/Neth/602/09, PRE Number Analyzed 52 participants 84 participants 42 participants 55 participants
25
  48.1%
30
  35.7%
17
  40.5%
20
  36.4%
Flu A/Neth/602/09, D21 Number Analyzed 51 participants 82 participants 44 participants 43 participants
51
 100.0%
82
 100.0%
39
  88.6%
35
  81.4%
37.Secondary Outcome
Title Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Hide Description Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame At Day 0 (PRE) and at Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 52 84 44 55
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/Neth/602/09, PRE Number Analyzed 52 participants 84 participants 42 participants 55 participants
19.3
(11.1 to 33.5)
13.8
(9.0 to 20.9)
15.0
(8.2 to 27.2)
15.3
(8.8 to 26.6)
Flu A/Neth/602/09, D21 Number Analyzed 51 participants 82 participants 44 participants 43 participants
427.6
(244.5 to 748.0)
296.1
(181.7 to 482.7)
231.1
(111.9 to 477.3)
138.3
(63.2 to 302.7)
38.Secondary Outcome
Title Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
Hide Description A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Time Frame At Day 0 (PRE) and at Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 40 68 36 42
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/Neth/602/09, PRE Number Analyzed 40 participants 68 participants 34 participants 42 participants
18
  45.0%
26
  38.2%
13
  38.2%
13
  31.0%
Flu A/Neth/602/09, D42 Number Analyzed 34 participants 63 participants 36 participants 36 participants
34
 100.0%
63
 100.0%
35
  97.2%
33
  91.7%
39.Secondary Outcome
Title Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Hide Description Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame At Day 0 (PRE) and at Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 40 68 36 42
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/Neth/602/09, PRE Number Analyzed 40 participants 68 participants 34 participants 42 participants
16.7
(9.1 to 30.8)
15.0
(9.3 to 24.1)
12.0
(6.7 to 21.4)
13.6
(7.3 to 25.5)
Flu A/Neth/602/09, D42 Number Analyzed 34 participants 63 participants 36 participants 36 participants
1389.3
(835.5 to 2310.4)
1786.9
(1258.6 to 2537.0)
428.4
(208.7 to 879.6)
146.1
(74.3 to 287.5)
40.Secondary Outcome
Title Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations
Hide Description Vaccine responses are defined as the incidence rate of vaccinated subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Time Frame At Day 0 (PRE) and at Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 45 70 37 43
Measure Type: Count of Participants
Unit of Measure: Participants
41
  91.1%
57
  81.4%
27
  73.0%
24
  55.8%
41.Secondary Outcome
Title Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations
Hide Description Vaccine response was defined as at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09.
Time Frame At Day 0 (PRE) and at Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Arm/Group Title Arepanrix/F1 Group Arepanrix/F2 Group GSK2340273A/F1 Group GSK2340273A/F2 Group
Hide Arm/Group Description:
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 32 54 30 34
Measure Type: Count of Participants
Unit of Measure: Participants
31
  96.9%
54
 100.0%
26
  86.7%
23
  67.6%
42.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame During the 7-day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Arm/Group Title Arepanrix/F1 6M-5Y Group Arepanrix/F1 6Y-9Y Group Arepanrix/F2 6M-5Y Group Arepanrix/F2 6Y-9Y Group GSK2340273A/F1 6M-5Y Group GSK2340273A/F1 6Y-9Y Group GSK2340273A/F2 6M-5Y Group GSK2340273A/F2 6Y-9Y Group
Hide Arm/Group Description:
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 47 18 48 12 45 17 44 18
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
27
  57.4%
14
  77.8%
26
  54.2%
9
  75.0%
18
  40.0%
12
  70.6%
15
  34.1%
10
  55.6%
Grade 3 Pain
4
   8.5%
1
   5.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
Any Redness
5
  10.6%
4
  22.2%
4
   8.3%
2
  16.7%
1
   2.2%
0
   0.0%
1
   2.3%
1
   5.6%
Grade 3 Redness
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Swelling
1
   2.1%
2
  11.1%
1
   2.1%
1
   8.3%
1
   2.2%
0
   0.0%
1
   2.3%
0
   0.0%
Grade 3 Swelling
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
43.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Arm/Group Title Arepanrix/F1 6M-5Y Group Arepanrix/F1 6Y-9Y Group Arepanrix/F1 Out Group Arepanrix/F2 6M-5Y Group Arepanrix/F2 6Y-9Y Group GSK2340273A/F1 6M-5Y Group GSK2340273A/F1 6Y-9Y Group GSK2340273A/F2 6M-5Y Group GSK2340273A/F2 6Y-9Y Group
Hide Arm/Group Description:
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, out of age interval, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 47 18 1 49 12 46 17 44 18
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 47 participants 18 participants 1 participants 48 participants 12 participants 46 participants 17 participants 44 participants 18 participants
27
  57.4%
14
  77.8%
1
 100.0%
26
  54.2%
9
  75.0%
19
  41.3%
12
  70.6%
15
  34.1%
10
  55.6%
Grade 3 Pain, Dose 1 Number Analyzed 47 participants 18 participants 1 participants 48 participants 12 participants 46 participants 17 participants 44 participants 18 participants
4
   8.5%
1
   5.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
1
   5.9%
0
   0.0%
0
   0.0%
Any Redness, Dose 1 Number Analyzed 47 participants 18 participants 1 participants 48 participants 12 participants 46 participants 17 participants 44 participants 18 participants
5
  10.6%
4
  22.2%
0
   0.0%
4
   8.3%
2
  16.7%
1
   2.2%
0
   0.0%
1
   2.3%
1
   5.6%
Grade 3 Redness, Dose 1 Number Analyzed 47 participants 18 participants 1 participants 48 participants 12 participants 46 participants 17 participants 44 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 47 participants 18 participants 1 participants 48 participants 12 participants 46 participants 17 participants 44 participants 18 participants
1
   2.1%
2
  11.1%
0
   0.0%
1
   2.1%
1
   8.3%
1
   2.2%
0
   0.0%
1
   2.3%
0
   0.0%
Grade 3 Swelling, Dose 1 Number Analyzed 47 participants 18 participants 1 participants 48 participants 12 participants 46 participants 17 participants 44 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 41 participants 17 participants 0 participants 44 participants 11 participants 41 participants 17 participants 41 participants 16 participants
22
  53.7%
13
  76.5%
0
25
  56.8%
7
  63.6%
11
  26.8%
8
  47.1%
9
  22.0%
7
  43.8%
Grade 3 Pain, Dose 2 Number Analyzed 41 participants 17 participants 0 participants 44 participants 11 participants 41 participants 17 participants 41 participants 16 participants
4
   9.8%
0
   0.0%
0
1
   2.3%
2
  18.2%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
Any Redness, Dose 2 Number Analyzed 41 participants 17 participants 0 participants 44 participants 11 participants 41 participants 17 participants 41 participants 16 participants
5
  12.2%
1
   5.9%
0
3
   6.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Redness, Dose 2 Number Analyzed 41 participants 17 participants 0 participants 44 participants 11 participants 41 participants 17 participants 41 participants 16 participants
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 41 participants 17 participants 0 participants 44 participants 11 participants 41 participants 17 participants 41 participants 16 participants
1
   2.4%
1
   5.9%
0
2
   4.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Swelling, Dose 2 Number Analyzed 41 participants 17 participants 0 participants 44 participants 11 participants 41 participants 17 participants 41 participants 16 participants
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Pain, Across doses Number Analyzed 47 participants 18 participants 1 participants 49 participants 12 participants 46 participants 17 participants 44 participants 18 participants
35
  74.5%
15
  83.3%
1
 100.0%
33
  67.3%
9
  75.0%
22
  47.8%
12
  70.6%
18
  40.9%
12
  66.7%
Grade 3 Pain, Across doses Number Analyzed 47 participants 18 participants 1 participants 49 participants 12 participants 46 participants 17 participants 44 participants 18 participants
7
  14.9%
1
   5.6%
0
   0.0%
1
   2.0%
2
  16.7%
1
   2.2%
1
   5.9%
0
   0.0%
1
   5.6%
Any Redness, Across doses Number Analyzed 47 participants 18 participants 1 participants 49 participants 12 participants 46 participants 17 participants 44 participants 18 participants
7
  14.9%
4
  22.2%
0
   0.0%
6
  12.2%
2
  16.7%
1
   2.2%
0
   0.0%
1
   2.3%
1
   5.6%
Grade 3 Redness, Across doses Number Analyzed 47 participants 18 participants 1 participants 49 participants 12 participants 46 participants 17 participants 44 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Swelling, Across doses Number Analyzed 47 participants 18 participants 1 participants 49 participants 12 participants 46 participants 17 participants 44 participants 18 participants
2
   4.3%
2
  11.1%
0
   0.0%
3
   6.1%
1
   8.3%
1
   2.2%
0
   0.0%
1
   2.3%
0
   0.0%
Grade 3 Swelling, Across doses Number Analyzed 47 participants 18 participants 1 participants 49 participants 12 participants 46 participants 17 participants 44 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
44.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Arm/Group Title Arepanrix/F1 6M-35M Group Arepanrix/F1 3Y-5Y Group Arepanrix/F1 6Y-9Y Group Arepanrix/F1 Out Group Arepanrix/F2 6M-35M Group Arepanrix/F2 3Y-5Y Group Arepanrix/F2 6Y-9Y Group GSK2340273A/F1 6M-35M Group GSK2340273A/F1 3Y-5Y Group GSK2340273A/F1 6Y-9Y Group GSK2340273A/F2 6M-35M Group GSK2340273A/F2 3Y-6Y Group GSK2340273A/F2 6Y-9Y Group
Hide Arm/Group Description:
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, out of age interval, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 22 25 18 1 46 53 26 24 22 17 23 21 18
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 22 participants 25 participants 18 participants 1 participants 46 participants 52 participants 26 participants 24 participants 22 participants 17 participants 23 participants 21 participants 18 participants
12
  54.5%
15
  60.0%
14
  77.8%
1
 100.0%
20
  43.5%
34
  65.4%
22
  84.6%
10
  41.7%
9
  40.9%
12
  70.6%
8
  34.8%
7
  33.3%
10
  55.6%
Grade 3 Pain, Dose 1 Number Analyzed 22 participants 25 participants 18 participants 1 participants 46 participants 52 participants 26 participants 24 participants 22 participants 17 participants 23 participants 21 participants 18 participants
2
   9.1%
2
   8.0%
1
   5.6%
0
   0.0%
1
   2.2%
3
   5.8%
2
   7.7%
1
   4.2%
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
Any Redness, Dose 1 Number Analyzed 22 participants 25 participants 18 participants 1 participants 46 participants 52 participants 26 participants 24 participants 22 participants 17 participants 23 participants 21 participants 18 participants
2
   9.1%
3
  12.0%
4
  22.2%
0
   0.0%
4
   8.7%
4
   7.7%
2
   7.7%
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
1
   5.6%
Grade 3 Redness, Dose 1 Number Analyzed 22 participants 25 participants 18 participants 1 participants 46 participants 52 participants 26 participants 24 participants 22 participants 17 participants 23 participants 21 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 22 participants 25 participants 18 participants 1 participants 46 participants 52 participants 26 participants 24 participants 22 participants 17 participants 23 participants 21 participants 18 participants
0
   0.0%
1
   4.0%
2
  11.1%
0
   0.0%
3
   6.5%
2
   3.8%
1
   3.8%
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
0
   0.0%
Grade 3 Swelling, Dose 1 Number Analyzed 22 participants 25 participants 18 participants 1 participants 46 participants 52 participants 26 participants 24 participants 22 participants 17 participants 23 participants 21 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 21 participants 20 participants 17 participants 0 participants 41 participants 49 participants 24 participants 21 participants 20 participants 17 participants 20 participants 21 participants 16 participants
12
  57.1%
10
  50.0%
13
  76.5%
0
18
  43.9%
35
  71.4%
19
  79.2%
5
  23.8%
6
  30.0%
8
  47.1%
4
  20.0%
5
  23.8%
7
  43.8%
Grade 3 Pain, Dose 2 Number Analyzed 21 participants 20 participants 17 participants 0 participants 41 participants 49 participants 24 participants 21 participants 20 participants 17 participants 20 participants 21 participants 16 participants
3
  14.3%
1
   5.0%
0
   0.0%
0
3
   7.3%
2
   4.1%
3
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
Any Redness, Dose 2 Number Analyzed 21 participants 20 participants 17 participants 0 participants 41 participants 49 participants 24 participants 21 participants 20 participants 17 participants 20 participants 21 participants 16 participants
2
   9.5%
3
  15.0%
1
   5.9%
0
1
   2.4%
2
   4.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Redness, Dose 2 Number Analyzed 21 participants 20 participants 17 participants 0 participants 41 participants 49 participants 24 participants 21 participants 20 participants 17 participants 20 participants 21 participants 16 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 21 participants 20 participants 17 participants 0 participants 41 participants 49 participants 24 participants 21 participants 20 participants 17 participants 20 participants 21 participants 16 participants
0
   0.0%
1
   5.0%
1
   5.9%
0
1
   2.4%
3
   6.1%
2
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Swelling, Dose 2 Number Analyzed 21 participants 20 participants 17 participants 0 participants 41 participants 49 participants 24 participants 21 participants 20 participants 17 participants 20 participants 21 participants 16 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Pain, Across Doses Number Analyzed 22 participants 25 participants 18 participants 1 participants 46 participants 53 participants 26 participants 24 participants 22 participants 17 participants 23 participants 21 participants 18 participants
16
  72.7%
19
  76.0%
15
  83.3%
1
 100.0%
25
  54.3%
44
  83.0%
22
  84.6%
11
  45.8%
11
  50.0%
12
  70.6%
9
  39.1%
9
  42.9%
12
  66.7%
Grade 3 Pain, Across Doses Number Analyzed 22 participants 25 participants 18 participants 1 participants 46 participants 53 participants 26 participants 24 participants 22 participants 17 participants 23 participants 21 participants 18 participants
4
  18.2%
3
  12.0%
1
   5.6%
0
   0.0%
3
   6.5%
5
   9.4%
5
  19.2%
1
   4.2%
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
1
   5.6%
Any Redness, Across Doses Number Analyzed 22 participants 25 participants 18 participants 1 participants 46 participants 53 participants 26 participants 24 participants 22 participants 17 participants 23 participants 21 participants 18 participants
3
  13.6%
4
  16.0%
4
  22.2%
0
   0.0%
5
  10.9%
5
   9.4%
2
   7.7%
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
1
   5.6%
Grade 3 Redness, Across Doses Number Analyzed 22 participants 25 participants 18 participants 1 participants 46 participants 53 participants 26 participants 24 participants 22 participants 17 participants 23 participants 21 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Swelling, Across Doses Number Analyzed 22 participants 25 participants 18 participants 1 participants 46 participants 53 participants 26 participants 24 participants 22 participants 17 participants 23 participants 21 participants 18 participants
0
   0.0%
2
   8.0%
2
  11.1%
0
   0.0%
4
   8.7%
4
   7.5%
3
  11.5%
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
0
   0.0%
Grade 3 Swelling, Across Doses Number Analyzed 22 participants 25 participants 18 participants 1 participants 46 participants 53 participants 26 participants 24 participants 22 participants 17 participants 23 participants 21 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
45.Secondary Outcome
Title Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Hide Description Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 7-day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Arm/Group Title Arepanrix/F1 6M-5Y Group Arepanrix/F2 6M-5Y Group GSK2340273A/F1 6M-5Y Group GSK2340273A/F2 6M-5Y Group
Hide Arm/Group Description:
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 47 48 45 44
Measure Type: Count of Participants
Unit of Measure: Participants
Any Drowsiness
11
  23.4%
11
  22.9%
8
  17.8%
9
  20.5%
Grade 3 Drowsiness
2
   4.3%
1
   2.1%
0
   0.0%
0
   0.0%
Related Drowsiness
5
  10.6%
8
  16.7%
5
  11.1%
7
  15.9%
Any Irritability
22
  46.8%
18
  37.5%
14
  31.1%
8
  18.2%
Grade 3 Irritability
3
   6.4%
3
   6.3%
0
   0.0%
0
   0.0%
Related Irritability
19
  40.4%
15
  31.3%
12
  26.7%
8
  18.2%
Any Loss of appetite
16
  34.0%
17
  35.4%
6
  13.3%
9
  20.5%
Grade 3 Loss of appetite
1
   2.1%
1
   2.1%
0
   0.0%
1
   2.3%
Related Loss of appetite
9
  19.1%
12
  25.0%
3
   6.7%
8
  18.2%
Any Temperature (Axillary)
8
  17.0%
6
  12.5%
2
   4.4%
1
   2.3%
Grade 3 Temperature (Axillary)
1
   2.1%
0
   0.0%
0
   0.0%
0
   0.0%
Related Temperature (Axillary)
6
  12.8%
3
   6.3%
1
   2.2%
1
   2.3%
46.Secondary Outcome
Title Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 7-day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Arm/Group Title Arepanrix/F1 6Y-9Y Group Arepanrix/F2 6Y-9Y Group GSK2340273A/F1 6Y-9Y Group GSK2340273A/F2 6Y-9Y Group
Hide Arm/Group Description:
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Overall Number of Participants Analyzed 18 12 17 18
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
3
  16.7%
4
  33.3%
4
  23.5%
4
  22.2%
Grade 3 Fatigue
0
   0.0%
0
   0.0%
1
   5.9%
0
   0.0%
Related Fatigue
2
  11.1%
3
  25.0%
4
  23.5%
3
  16.7%
Any Gastro-intestinal symptoms
1
   5.6%
2
  16.7%
3
  17.6%
2
  11.1%
Grade 3 Gastro-intestinal symptoms
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Gastro-intestinal symptoms
0
   0.0%
1
   8.3%
3
  17.6%
0
   0.0%
Any Headache
4
  22.2%
4
  33.3%
2
  11.8%
2
  11.1%
Grade 3 Headache
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Headache
3
  16.7%
2
  16.7%
1
   5.9%
2
  11.1%
Any Joint pain at other location
0
   0.0%
0
   0.0%
2
  11.8%
1
   5.6%
Grade 3 Joint pain at other location
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Joint pain at other location
0
   0.0%
0
   0.0%