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Trial record 28 of 28 for:    pandemrix AND influenza vaccine

Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged ≥18 Years

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: NCT00719043
Recruitment Status : Completed
First Posted : July 21, 2008
Results First Posted : February 7, 2014
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: A/turkey H5N1 vaccine
Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)
Biological: Placebo
Enrollment 841
Recruitment Details Study duration was of approximately 909 days for all subjects.
Pre-assignment Details  
Arm/Group Title A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group
Hide Arm/Group Description Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Period Title: Overall Study
Started 120 121 119 119 122 120 120
Completed 88 [1] 96 [1] 99 [1] 96 [1] 95 [1] 86 [1] 92 [1]
Not Completed 32 25 20 23 27 34 28
Reason Not Completed
Adverse Event             5             1             2             2             1             4             4
Lost to Follow-up             14             10             8             9             10             9             9
Protocol Violation             0             0             0             0             0             1             0
Other             1             0             1             2             0             2             1
Withdrawal by Subject             12             14             9             10             16             18             14
[1]
Up to Day 909
Arm/Group Title A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group Total
Hide Arm/Group Description Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 120 121 119 119 122 120 120 841
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 121 participants 119 participants 119 participants 122 participants 120 participants 120 participants 841 participants
49.8  (18.01) 49.6  (17.93) 50.7  (17.67) 49.2  (17.75) 50.3  (17.77) 50.1  (18.92) 50.0  (18.03) 49.95  (17.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 121 participants 119 participants 119 participants 122 participants 120 participants 120 participants 841 participants
Female
80
  66.7%
73
  60.3%
69
  58.0%
70
  58.8%
68
  55.7%
70
  58.3%
75
  62.5%
505
  60.0%
Male
40
  33.3%
48
  39.7%
50
  42.0%
49
  41.2%
54
  44.3%
50
  41.7%
45
  37.5%
336
  40.0%
1.Primary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame At Day 559
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 83 87 80 72
Measure Type: Number
Unit of Measure: Subjects
71 81 73 65
2.Primary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group
Time Frame At Day 192
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 99
Measure Type: Number
Unit of Measure: Subjects
44
3.Primary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
Hide Description HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame At Days 549 and 559
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 83 88 81 72
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/turkey, Day 549 (N=83,88,81,72)
11.1
(8.8 to 14.1)
8.3
(7.0 to 9.7)
9.2
(7.6 to 11.2)
11.4
(9.1 to 14.4)
A/turkey, Day 559 (N= 83,88,81,72)
356.7
(265.9 to 478.5)
266.4
(202.2 to 351.2)
446.6
(336.0 to 593.7)
343.9
(254.2 to 465.3)
4.Primary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
Hide Description HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time Frame At Days 182 and 192
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 100
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/turkey strain, Day 182 (N=100)
10.8
(8.4 to 13.9)
A/turkey strain, Day 192 (N=99)
43.5
(32.6 to 58.0)
5.Primary Outcome
Title Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Hide Description A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame At Days 549 and 559
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 88 87 81 72
Measure Type: Number
Unit of Measure: Subjects
A/turkey, Day 549 (N=83,88,81,72) 15 8 10 13
A/turkey, Day 559 (N= 83,87,80,72) 79 83 77 69
6.Primary Outcome
Title Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Hide Description A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time Frame At Days 182 and 192
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: Subjects
A/turkey strain, Day 182 (N=100) 24
A/turkey strain, Day 192 (N=99) 64
7.Primary Outcome
Title Number of Subjects With Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any was defined as an occurrence of the specified solicited local symptom regardless of its intensity.
Time Frame Within the 7-day (Days 0-6) post vaccination periods
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 120 121 119 119 122 120 120
Measure Type: Number
Unit of Measure: Subjects
Any Pain 98 100 101 93 102 90 95
Any Redness 8 4 12 9 14 4 8
Any Swelling 6 7 15 4 16 9 11
8.Primary Outcome
Title Number of Subjects With Solicited General Symptoms
Hide Description Solicited general symptoms assessed were fatigue, headache, joint pain at other locations (joint pain), muscle aches, shivering, sweating and fever. Any was defined as an occurrence of the specified solicited general symptom, irrespective of its intensity or relationship to vaccination. Any fever was defined as oral temperature higher than or equal to (≥) 38.0 degrees Celsius (°C).
Time Frame Within the 7-day (Days 0-6) post vaccination periods
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 120 121 119 119 122 120 120
Measure Type: Number
Unit of Measure: Subjects
Any Fatigue 45 50 47 44 42 39 47
Any Headache 44 50 42 44 44 35 47
Any Joint pain 33 37 36 26 28 16 30
Any Muscle aches 54 52 59 49 48 42 55
Any Shivering 12 18 16 8 20 10 18
Any Sweating 15 20 15 11 14 10 11
Any Fever 2 5 6 3 8 2 2
9.Primary Outcome
Title Number of Subjects With Medically-attended Adverse Events (MAEs)
Hide Description MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).
Time Frame From Day 0 to Day 909
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 120 121 119 119 122 120 120
Measure Type: Number
Unit of Measure: Subjects
68 66 77 75 62 63 70
10.Primary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any occurrence of an unsolicited AE in a subject, regardless of intensity grade or relation to vaccination.
Time Frame Within the 43-day (Days 0-42) post-vaccination periods
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 120 121 119 119 122 120 120
Measure Type: Number
Unit of Measure: Subjects
70 72 78 68 67 68 75
11.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as an occurrence of an SAE, regardless its relationship to vaccination.
Time Frame From Day 0 to Day 909
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 120 121 119 119 122 120 120
Measure Type: Number
Unit of Measure: Subjects
12 14 11 9 11 15 12
12.Secondary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time Frame At Day 192
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 99
Measure Type: Number
Unit of Measure: Subjects
44
13.Secondary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain.
Hide Description HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time Frame At Days 182 and 192
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 95 92
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/turkey, Day 182 (N=95,92)
17.6
(13.1 to 23.6)
12.2
(9.7 to 15.4)
A/turkey, Day 192 (N=94,86)
308.4
(231.1 to 411.5)
374.4
(297.9 to 470.5)
14.Secondary Outcome
Title Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Hide Description A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time Frame At Days 182 and 192
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 95 92
Measure Type: Number
Unit of Measure: Subjects
A/turkey, Day 182 (N=95,92) 30 25
A/turkey, Day 192 (N=94,86) 89 85
15.Secondary Outcome
Title Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Hide Description A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time Frame At Day 224
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Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 89 86 98
Measure Type: Number
Unit of Measure: Subjects
82 82 60
16.Secondary Outcome
Title Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Hide Description A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame At Day 591
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 82 88 80 71
Measure Type: Number
Unit of Measure: Subjects
77 83 75 67
17.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
Hide Description GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time Frame At Days 192 and 224
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 94 86 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold increase
A/turkey, Day 192 (N=94,86,99)
17.8
(12.0 to 26.2)
30.2
(22.2 to 41.2)
4.0
(2.9 to 5.5)
A/turkey, Day 224 (N=89,86,98)
11.2
(7.8 to 16.3)
17.2
(12.9 to 23.0)
4.2
(3.0 to 5.7)
18.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
Hide Description GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 549. This outcome measure solely concerns subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time Frame At Day 559
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 83 88 80 72 81
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold increase
A/turkey, Day 559 (N=83,87,80,72,81)
32.0
(21.9 to 46.8)
32.0
(23.4 to 43.7)
48.1
(34.6 to 66.9)
30.1
(21.0 to 43.0)
19.5
(13.4 to 28.4)
A/turkey, Day 591 (N=82,88,80,71,81)
26.7
(18.4 to 38.7)
29.1
(21.3 to 39.9)
35.2
(25.4 to 48.8)
22.0
(15.8 to 30.7)
14.8
(10.4 to 21.2)
19.Secondary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame At Day 591
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 82 88 80 71
Measure Type: Number
Unit of Measure: Subjects
69 80 70 61
20.Secondary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time Frame At Day 224
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 89 86 98
Measure Type: Number
Unit of Measure: Subjects
64 75 42
21.Secondary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
Hide Description HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time Frame At Days 0, 182,192, 224, 549 and 729
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 95 92
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/turkey, Day 0 (N= 95,92)
9.2
(7.4 to 11.4)
6.6
(5.7 to 7.7)
A/turkey, Day 182 (N=95,92)
17.6
(13.1 to 23.6)
12.2
(9.7 to 15.4)
A/turkey, Day 192 (N=94,86)
308.4
(231.1 to 411.5)
374.4
(297.9 to 470.5)
A/turkey, Day 224 (N=93,91)
195.0
(146.7 to 259.1)
213.7
(170.7 to 267.5)
A/turkey, Day 549 (N=84,81)
32.7
(24.4 to 43.6)
28.7
(22.6 to 36.5)
A/turkey, Day 729 (N=78,78)
41.8
(32.1 to 54.4)
31.2
(24.8 to 39.2)
22.Secondary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
Hide Description HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame At Days 0, 182, 549, 559, 591 and 729
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
Arm/Group Title Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 90 96 99 89
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/turkey, Day 0 (N=90,96,99,89)
8.0
(6.6 to 9.8)
7.1
(6.0 to 8.3)
6.6
(5.7 to 7.6)
6.9
(5.9 to 8.0)
A/turkey, Day 182 (N=90,96,99,89)
13.5
(10.3 to 17.8)
10.8
(8.4 to 13.9)
12.8
(10.0 to 16.4)
13.7
(10.6 to 17.7)
A/turkey, Day 549 (N=83,86,81,72)
11.1
(8.8 to 14.1)
8.4
(7.1 to 9.9)
9.2
(7.6 to 11.2)
11.4
(9.1 to 14.4)
A/turkey, Day 559 (N=83,85,80,72)
356.7
(265.9 to 478.5)
266.4
(202.2 to 350.9)
446.6
(336.0 to 593.7)
343.9
(254.2 to 465.3)
A/turkey, Day 591 (N=82,86,80,71)
300.3
(225.6 to 399.7)
242.4
(182.8 to 321.5)
326.9
(241.6 to 442.2)
254.4
(188.5 to 343.3)
A/turkey, Day 729 (N=81,83,79,70)
119.2
(95.3 to 149.0)
96.6
(75.1 to 124.2)
134.8
(106.4 to 170.9)
105.6
(84.1 to 132.6)
23.Secondary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
Hide Description HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time Frame At Days 0, 182, 192, 224, 549, 559, 591 and 729
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
Arm/Group Title Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/turkey, Day 0 (N=99)
8.0
(6.6 to 9.7)
A/turkey, Day 182 (N=99)
10.6
(8.2 to 13.6)
A/turkey, Day 192 (N=98)
43.4
(32.5 to 58.0)
A/turkey, Day 224 (N=98)
43.7
(32.1 to 59.5)
A/turkey, Day 549 (N=81)
15.6
(12.0 to 20.2)
A/turkey, Day 559 (N=80)
314.4
(229.5 to 430.8)
A/turkey, Day 591 (N=80)
236.2
(172.3 to 323.8)
A/turkey, Day 729 (N=80)
98.1
(76.4 to 125.9)
24.Secondary Outcome
Title Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain.
Hide Description A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time Frame At Days 0, 182,192, 224, 549 and 729
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 95 92
Measure Type: Number
Unit of Measure: Subjects
A/turkey, Day 0 (N= 95,92) 16 7
A/turkey, Day 182 (N=95,92) 30 25
A/turkey, Day 192 (N=94,86) 89 85
A/turkey, Day 224 (N=93,91) 86 87
A/turkey, Day 549 (N=84,81) 42 40
A/turkey, Day 729 (N=78,78) 47 49
25.Secondary Outcome
Title Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain
Hide Description A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time Frame At Days 0, 182, 549, 559, 591 and 729
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
Arm/Group Title Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 90 96 99 89
Measure Type: Number
Unit of Measure: Subjects
A/turkey, Day 0 (N=90,96,99,89) 11 8 8 6
A/turkey, Day 182 (N=90,96,99,89) 25 20 28 31
A/turkey, Day 549 (N=83,86,81,72) 15 8 10 13
A/turkey, Day 559 (N=83,85,80,72) 79 81 77 69
A/turkey, Day 591 (N=82,86,80,71) 77 82 75 67
A/turkey, Day 729 (N=81,83,79,70) 75 73 71 66
26.Secondary Outcome
Title Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain
Hide Description A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time Frame At Days 0, 182, 192, 224, 549, 559, 591 and 729
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
Arm/Group Title Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 99
Measure Type: Number
Unit of Measure: Subjects
A/turkey, Day 0 (N=99) 8
A/turkey, Day 182 (N=99) 23
A/turkey, Day 192 (N=98) 63
A/turkey, Day 224 (N=98) 59
A/turkey, Day 549 (N=81) 21
A/turkey, Day 559 (N=80) 76
A/turkey, Day 591 (N=80) 73
A/turkey, Day 729 (N=80) 70
27.Secondary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.
Hide Description HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time Frame At Days 0, 10, 42, 182 and 549
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 95 92
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/Indo, Day 0 (N=95,92)
6.7
(5.7 to 7.9)
5.9
(5.4 to 6.5)
A/Indo, Day 10 (N=95,92)
32.3
(23.5 to 44.4)
30.7
(23.4 to 40.4)
A/Indo, Day 42 (N=93,88)
44.1
(32.4 to 59.9)
44.8
(34.7 to 57.9)
A/Indo, Day 182 (N=95,92)
22.4
(16.7 to 30.0)
15.7
(12.3 to 20.0)
A/Indo, Day 549 (N=84,81)
24.0
(17.3 to 33.2)
22.7
(17.6 to 29.4)
28.Secondary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.
Hide Description HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time Frame At Days 0, 10, 42, 182, 549 and 559
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
Arm/Group Title Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 90 96 99 89 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/Indo, Day 0 (N=90,96,99,89,99)
5.9
(5.4 to 6.5)
5.7
(5.3 to 6.2)
5.7
(5.1 to 6.3)
5.6
(5.1 to 6.1)
5.9
(5.3 to 6.5)
A/Indo, Day 10 (N=89,95,98,87,97)
27.0
(19.4 to 37.6)
17.2
(13.2 to 22.3)
31.7
(24.2 to 41.4)
26.2
(19.2 to 35.8)
6.3
(5.6 to 7.1)
A/Indo, Day 42 (N=87,94,96,87,97)
37.5
(27.9 to 50.4)
27.3
(21.0 to 35.4)
45.7
(35.0 to 59.7)
36.6
(27.1 to 49.5)
6.2
(5.5 to 7.0)
A/Indo, Day 182 (N=90,96,99,89,99)
16.4
(12.5 to 21.6)
13.7
(10.8 to 17.5)
17.8
(14.0 to 22.6)
16.2
(12.5 to 21.1)
6.7
(5.8 to 7.7)
A/Indo, Day 549 (N=83,86,81,72,81)
8.1
(6.6 to 10.0)
7.9
(6.7 to 9.4)
7.8
(6.5 to 9.3)
9.2
(7.4 to 11.3)
6.2
(5.5 to 6.9)
A/Indo, Day 559 (N=83,85,81,72,80)
304.3
(232.4 to 398.5)
231.9
(177.1 to 303.5)
376.6
(285.2 to 497.2)
289.2
(215.8 to 387.7)
113.1
(82.4 to 155.3)
29.Secondary Outcome
Title Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.
Hide Description A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time Frame At Day 0, Day 10, Day 42, Day 182 and Day 549
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 95 92 99
Measure Type: Number
Unit of Measure: Subjects
A/Indo, Day 0 (N=95,92) 6 6.7 2
A/Indo, Day 10 (N=95,92) 50 32.3 4
A/Indo, Day 42 (N=93,88) 57 44.1 3
A/Indo, Day 182 (N=95,92) 42 22.4 9
A/Indo, Day 549 (N=84,81) 38 24.0 2
30.Secondary Outcome
Title Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.
Hide Description A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time Frame At Day 0, Day 10, Day 42, Day 182, Day 549, and Day 559
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
Arm/Group Title Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 90 96 99 89 99
Measure Type: Number
Unit of Measure: Subjects
A/Indo, Day 0 (N=90,96,99,89,99) 1 0 3 2 2
A/Indo, Day 10 (N=89,95,98,87,97) 41 36 56 44 4
A/Indo, Day 42 (N=87,94,96,87,97) 50 51 68 53 3
A/Indo, Day 182 (N=90,96,99,89,99) 28 29 35 32 9
A/Indo, Day 549 (N=83,86,81,72,81) 9 9 7 11 2
A/Indo, Day 559 (N=83,85,81,72,80) 79 80 77 68 68
31.Secondary Outcome
Title Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.
Hide Description

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 0.

This outcome measure only concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

Time Frame At Days 10 and 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group
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Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 95 92 89 97 98 87
Measure Type: Number
Unit of Measure: Subjects
A/Indo, Day 10 (N=95,92,89,97,98,87) 42 50 38 33 52 40
A/Indo, Day 42 (N=93,88,87,96,96,87) 50 61 49 51 64 51
32.Secondary Outcome
Title Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. This outcome measure only concerns the Naïve Placebo-A/turkey H5N1-Formulation 3 Group, for whom the pre-vaccination time point corresponds to the Day 192 time point.
Time Frame At Days 192 and 224
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Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
Arm/Group Title Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description:
Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: Subjects
A/Indo, Day 192 8
A/Indo, Day 224 3
Time Frame Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0–42) post vaccination periods.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Hide Arm/Group Description Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
All-Cause Mortality
A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/120 (10.00%)   14/121 (11.57%)   11/119 (9.24%)   9/119 (7.56%)   11/122 (9.02%)   15/120 (12.50%)   12/120 (10.00%) 
Blood and lymphatic system disorders               
Lymphadenitis * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Cardiac disorders               
Bradycardia * 1  0/120 (0.00%)  0/121 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Coronary artery disease * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  1/119 (0.84%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Angina pectoris * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Arteriosclerosis coronary artery * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Atrial fibrillation * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Cardiac failure congestive * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Coronary artery occlusion * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  0/120 (0.00%) 
Endocarditis noninfective * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Mitral valve disease * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Myocardial infarction * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  1/119 (0.84%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Gastrointestinal disorders               
Pancreatitis * 1  0/120 (0.00%)  0/121 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  1/120 (0.83%) 
Colitis * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Dyspepsia * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Gastrointestinal haemorrhage * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Haemorrhoids * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Pancreatic mass * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Pancreatic pseudocyst * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Small intestinal obstruction * 1  0/120 (0.00%)  0/121 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Small intestinal perforation * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
General disorders               
Chest discomfort * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Mass * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Pain * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  0/120 (0.00%) 
Hepatobiliary disorders               
Cholecystitis * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Cholecystitis acute * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Immune system disorders               
Anaphylactic shock * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Infections and infestations               
Pneumonia * 1  1/120 (0.83%)  1/121 (0.83%)  1/119 (0.84%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Appendicitis * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  1/119 (0.84%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Bronchitis * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  1/120 (0.83%) 
Cellulitis gangrenous * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  1/119 (0.84%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Gastroenteritis salmonella * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Meningitis viral * 1  0/120 (0.00%)  0/121 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Post procedural infection * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Septic shock * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Staphylococcal infection * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Urinary tract infection * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Uterine infection * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  0/120 (0.00%) 
Injury, poisoning and procedural complications               
Ankle fracture * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  0/120 (0.00%) 
Head injury * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Lower limb fracture * 1  0/120 (0.00%)  0/121 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Lumbar vertebral fracture * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Multiple fractures * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Overdose * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Patella fracture * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Post procedural complication * 1  0/120 (0.00%)  0/121 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Postoperative ileus * 1  0/120 (0.00%)  0/121 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Subdural haematoma * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Metabolism and nutrition disorders               
Dehydration * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Hypoglycaemia * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Musculoskeletal and connective tissue disorders               
Exostosis * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Intervertebral disc disorder * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Intervertebral disc protrusion * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  0/120 (0.00%) 
Iron deficiency anaemia * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Musculoskeletal pain * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  1/119 (0.84%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Osteoarthritis * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Breast cancer * 1  1/120 (0.83%)  1/121 (0.83%)  1/119 (0.84%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Bladder transitional cell carcinoma recurrent * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  1/119 (0.84%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Breast cancer in situ * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  0/120 (0.00%) 
Breast cancer recurrent * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  0/120 (0.00%) 
Lung adenocarcinoma * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  1/119 (0.84%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Lung adenocarcinoma metastatic * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Lymphoma * 1  0/120 (0.00%)  0/121 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Malignant melanoma * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  0/120 (0.00%) 
Myelodysplastic syndrome * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Non-small cell lung cancer * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Ovarian adenoma * 1  0/120 (0.00%)  0/121 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Parathyroid tumour benign * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Prostate cancer * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Squamous cell carcinoma * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Testis cancer * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Thyroid cancer * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Nervous system disorders               
Cerebrovascular accident * 1  2/120 (1.67%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  0/120 (0.00%) 
Loss of consciousness * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Syncope * 1  1/120 (0.83%)  0/121 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Amnesia * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Carotid artery stenosis * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Presyncope * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Pregnancy, puerperium and perinatal conditions               
Abortion spontaneous * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Abortion spontaneous incomplete * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  0/120 (0.00%) 
Psychiatric disorders               
Bipolar disorder * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  1/119 (0.84%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Completed suicide * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Delirium * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Drug abuse * 1  0/120 (0.00%)  1/121 (0.83%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Renal and urinary disorders               
Nephrolithiasis * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  2/122 (1.64%)  0/120 (0.00%)  0/120 (0.00%) 
Urinary retention * 1  0/120 (0.00%)  0/121 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Reproductive system and breast disorders               
Endometriosis * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Ovarian cyst * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Pelvic pain * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Respiratory failure * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Acute respiratory failure * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  1/120 (0.83%) 
Chronic obstructive pulmonary disease * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  1/119 (0.84%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Pulmonary embolism * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Vascular disorders               
Arteriosclerosis * 1  1/120 (0.83%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  0/120 (0.00%)  0/120 (0.00%) 
Deep vein thrombosis * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/120 (0.00%) 
Hypertensive crisis * 1  0/120 (0.00%)  0/121 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  0/120 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Naïve Placebo-A/Turkey H5N1-Formulation 3 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   106/120 (88.33%)   109/121 (90.08%)   106/119 (89.08%)   103/119 (86.55%)   106/122 (86.89%)   101/120 (84.17%)   106/120 (88.33%) 
Gastrointestinal disorders               
Nausea * 1  2/120 (1.67%)  2/121 (1.65%)  10/119 (8.40%)  6/119 (5.04%)  3/122 (2.46%)  5/120 (4.17%)  5/120 (4.17%) 
Diarrhoea * 1  4/120 (3.33%)  4/121 (3.31%)  4/119 (3.36%)  8/119 (6.72%)  4/122 (3.28%)  5/120 (4.17%)  7/120 (5.83%) 
General disorders               
Pain  1  98/120 (81.67%)  100/121 (82.64%)  101/119 (84.87%)  93/119 (78.15%)  102/122 (83.61%)  90/120 (75.00%)  95/120 (79.17%) 
Redness  1  8/120 (6.67%)  4/121 (3.31%)  12/119 (10.08%)  9/119 (7.56%)  14/122 (11.48%)  4/120 (3.33%)  8/120 (6.67%) 
Swelling  1  6/120 (5.00%)  7/121 (5.79%)  15/119 (12.61%)  4/119 (3.36%)  16/122 (13.11%)  9/120 (7.50%)  11/120 (9.17%) 
Fatigue  1  45/120 (37.50%)  50/121 (41.32%)  47/119 (39.50%)  44/119 (36.97%)  42/122 (34.43%)  39/120 (32.50%)  47/120 (39.17%) 
Headache  1  44/120 (36.67%)  50/121 (41.32%)  47/119 (39.50%)  44/119 (36.97%)  44/122 (36.07%)  35/120 (29.17%)  47/120 (39.17%) 
Joint pain  1  33/120 (27.50%)  37/121 (30.58%)  36/119 (30.25%)  44/119 (36.97%)  42/122 (34.43%)  39/120 (32.50%)  30/120 (25.00%) 
Muscle aches  1  54/120 (45.00%)  52/121 (42.98%)  59/119 (49.58%)  49/119 (41.18%)  48/122 (39.34%)  42/120 (35.00%)  55/120 (45.83%) 
Shivering  1  12/120 (10.00%)  18/121 (14.88%)  16/119 (13.45%)  8/119 (6.72%)  20/122 (16.39%)  10/120 (8.33%)  18/120 (15.00%) 
Sweating  1  15/120 (12.50%)  20/121 (16.53%)  15/119 (12.61%)  11/119 (9.24%)  14/122 (11.48%)  10/120 (8.33%)  18/120 (15.00%) 
Fever  1  2/120 (1.67%)  5/121 (4.13%)  6/119 (5.04%)  3/119 (2.52%)  8/122 (6.56%)  2/120 (1.67%)  2/120 (1.67%) 
Infections and infestations               
Nasopharyngitis * 1  15/120 (12.50%)  9/121 (7.44%)  9/119 (7.56%)  14/119 (11.76%)  12/122 (9.84%)  11/120 (9.17%)  6/120 (5.00%) 
Upper respiratory tract infection * 1  7/120 (5.83%)  5/121 (4.13%)  6/119 (5.04%)  3/119 (2.52%)  6/122 (4.92%)  3/120 (2.50%)  5/120 (4.17%) 
Nervous system disorders               
Headache * 1  8/120 (6.67%)  11/121 (9.09%)  4/119 (3.36%)  6/119 (5.04%)  6/122 (4.92%)  10/120 (8.33%)  5/120 (4.17%) 
Respiratory, thoracic and mediastinal disorders               
Oropharyngeal pain * 1  9/120 (7.50%)  8/121 (6.61%)  9/119 (7.56%)  12/119 (10.08%)  1/122 (0.82%)  10/120 (8.33%)  11/120 (9.17%) 
Cough * 1  9/120 (7.50%)  7/121 (5.79%)  6/119 (5.04%)  5/119 (4.20%)  4/122 (3.28%)  5/120 (4.17%)  5/120 (4.17%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00719043     History of Changes
Other Study ID Numbers: 110624
First Submitted: July 18, 2008
First Posted: July 21, 2008
Results First Submitted: December 19, 2013
Results First Posted: February 7, 2014
Last Update Posted: July 9, 2018