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A Dose Ranging Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' GSK1557484A Vaccine in Children 6 to Less Than 36 Months of Age

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ClinicalTrials.gov Identifier: NCT02719743
Recruitment Status : Completed
First Posted : March 25, 2016
Results First Posted : June 3, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A).
Enrollment 185
Recruitment Details  
Pre-assignment Details  
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh. Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh. Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh. Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh. Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Period Title: Overall Study
Started 38 37 38 37 35
Completed 37 34 38 36 33
Not Completed 1 3 0 1 2
Reason Not Completed
Consent withdrawal             0             2             0             1             0
Migrated/moved from study area             0             0             0             0             2
Lost to Follow-up             1             1             0             0             0
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group Total
Hide Arm/Group Description Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh. Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh. Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh. Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh. Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh. Total of all reporting groups
Overall Number of Baseline Participants 38 37 38 37 35 185
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 38 participants 37 participants 38 participants 37 participants 35 participants 185 participants
21.9  (8.0) 22.6  (8.1) 21.6  (9.2) 20.8  (8.3) 20.3  (7.8) 21.4  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 38 participants 37 participants 35 participants 185 participants
Female
17
  44.7%
14
  37.8%
16
  42.1%
23
  62.2%
18
  51.4%
88
  47.6%
Male
21
  55.3%
23
  62.2%
22
  57.9%
14
  37.8%
17
  48.6%
97
  52.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 38 participants 37 participants 35 participants 185 participants
Asian - East Asian Heritage
21
  55.3%
21
  56.8%
22
  57.9%
21
  56.8%
19
  54.3%
104
  56.2%
Asian - South East Asian Heritage
16
  42.1%
16
  43.2%
16
  42.1%
16
  43.2%
16
  45.7%
80
  43.2%
Unspecified
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.5%
1.Primary Outcome
Title Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination
Hide Description The HI antibody titres were expressed in terms of immunogenicity indices for each group. Immunogenicity index (DGMT) = If the LL of the 95% CI for GMT group ratio is less than 0.25 then DGMT =0. If the LL of the 95% CI for GMT group ratio is greater than 1 then DGMT =1.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 and 2.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 36 33 37 31 35
Mean (Full Range)
Unit of Measure: Immunogenicity Index
1
(0 to 1)
0.54
(0 to 1)
0.57
(0 to 1)
0.40
(0 to 1)
0.34
(0 to 1)
2.Primary Outcome
Title Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination
Hide Description The MN antibody titres were expressed in terms of immunogenicity indices for each group. Immunogenicity index (DGMT) = If the LL of the 95% CI for GMT group ratio is less than 0.25 then DGMT =0. If the LL of the 95% CI for GMT group ratio is greater than 1 then DGMT =1.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 & 2 and with pre & post immune result of antibody of interest.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 36 31 37 29 35
Mean (Full Range)
Unit of Measure: Immunogenicity Index
1
(0 to 1)
0.56
(0 to 1)
0.57
(0 to 1)
0.32
(0 to 1)
0.33
(0 to 1)
3.Primary Outcome
Title Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination.
Hide Description Fever index was defined as the average temperature for each vaccine group. Fever index (DR) = The average temperature measurement for each vaccine group. Fever index from Days 0-2 after each dose Any temperature < 38°C (100.4 F) was assigned a value of 0. Any temperature > 40.5°C was assigned a value of 40.5. DR correspond to 243 minus the sum of recorded temperature values for 3 days after (dose 1 and dose 2)/243.
Time Frame During the 3-day follow-up period (i.e. on the day of vaccination and 2 subsequent days) after Dose 1 and Dose 2.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 and 2.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 36 33 37 31 35
Mean (Full Range)
Unit of Measure: Degrees Celsius
0.84
(0 to 1)
0.91
(0 to 1)
0.95
(0 to 1)
0.93
(0 to 1)
0.94
(0 to 1)
4.Primary Outcome
Title Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination.
Hide Description Fever index was defined as the average temperature for each vaccine group. Fever index (DR)= The average temperature measurement for each vaccine group. Fever index from Days 0-2 after each dose Any temperature < 38°C (100.4 F) was assigned a value of 0. Any temperature > 40.5°C was assigned a value of 40.5. DR correspond to 243 minus the sum of recorded temperature values for 3 days after (dose 1 and dose 2)/243.
Time Frame During the 3-day follow-up period (i.e. on the day of vaccination and 2 subsequent days) after Dose 1 and Dose 2.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 and 2.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 36 31 37 29 35
Mean (Full Range)
Unit of Measure: Degrees Celsius
0.84
(0 to 1)
0.91
(0 to 1)
0.95
(0 to 1)
0.93
(0 to 1)
0.94
(0 to 1)
5.Primary Outcome
Title Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains.
Hide Description MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer (Day 392) to the pre-vaccination (Day 385) reciprocal HI titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Time Frame At Day 392 (relative to Day 385) post booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 34 33 37 31 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold change
Flu A/Indonesia/5/2005 H5N1 HI Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
4.9
(3.8 to 6.3)
6.6
(4.9 to 9.0)
4.2
(3.4 to 5.3)
3.6
(2.9 to 4.5)
3.4
(2.8 to 4.1)
Flu A/duck/Bangladesh/19097/2013 H5N1 HI Number Analyzed 33 participants 31 participants 33 participants 31 participants 30 participants
5.2
(3.9 to 7.0)
6.0
(4.2 to 8.5)
4.0
(3.0 to 5.2)
3.4
(2.7 to 4.2)
2.7
(2.3 to 3.3)
Flu A/Vietnam/1194/2004 H5N1 HI Number Analyzed 33 participants 31 participants 33 participants 31 participants 30 participants
5.0
(3.7 to 6.8)
6.3
(4.5 to 8.7)
3.8
(3.0 to 4.8)
3.6
(2.9 to 4.5)
2.8
(2.2 to 3.4)
Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 HI Number Analyzed 33 participants 31 participants 33 participants 31 participants 30 participants
4.5
(3.2 to 6.5)
4.9
(3.5 to 6.9)
3.1
(2.3 to 4.2)
2.9
(2.2 to 3.8)
2.4
(2.0 to 3.0)
6.Primary Outcome
Title Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains.
Hide Description MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 392) reciprocal MN titer to the pre-vaccination (Day 385) reciprocal MN titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
Time Frame At Day 392 (relative to Day 385) post booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 34 33 37 31 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold change
Flu A/Indonesia/5/2005 H5N1 MN Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
4.3
(3.3 to 5.7)
4.8
(3.4 to 6.6)
3.2
(2.3 to 4.3)
2.8
(2.0 to 3.8)
2.5
(2.0 to 3.0)
Flu A/Vietnam/1194/2004 H5N1 MN Number Analyzed 33 participants 33 participants 35 participants 31 participants 32 participants
2.9
(2.2 to 3.8)
2.9
(2.1 to 4.1)
2.9
(2.2 to 3.8)
2.6
(2.1 to 3.3)
2.4
(1.9 to 3.1)
Flu A/duck/Bangladesh/19097/2013 H5N1 MN Number Analyzed 34 participants 33 participants 37 participants 30 participants 32 participants
2.6
(1.9 to 3.5)
3.0
(2.3 to 4.1)
2.6
(2.0 to 3.2)
2.1
(1.6 to 2.8)
2.8
(2.2 to 3.5)
7.Secondary Outcome
Title Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Hide Description Seroconversion rate (SCR) was defined as the proportion of subjects who have either a pre-vaccination reciprocal HI titer less than (<) 10 and a post-vaccination reciprocal titer greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Time Frame At Days 42, 385 and 392
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 36 33 37 31 35
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/Indonesia/5/2005 H5N1 HI, Day 42 Number Analyzed 36 participants 33 participants 37 participants 31 participants 35 participants
36
 100.0%
33
 100.0%
37
 100.0%
31
 100.0%
35
 100.0%
Flu A/Indonesia/5/2005 H5N1 HI, Day 385 Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
33
  97.1%
26
  78.8%
28
  75.7%
28
  90.3%
21
  65.6%
Flu A/Indonesia/5/2005 H5N1 HI, Day 392 Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
34
 100.0%
33
 100.0%
37
 100.0%
31
 100.0%
32
 100.0%
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 Number Analyzed 30 participants 24 participants 34 participants 25 participants 30 participants
30
 100.0%
22
  91.7%
33
  97.1%
23
  92.0%
25
  83.3%
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 Number Analyzed 31 participants 29 participants 32 participants 25 participants 27 participants
7
  22.6%
6
  20.7%
7
  21.9%
5
  20.0%
6
  22.2%
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 Number Analyzed 30 participants 29 participants 35 participants 25 participants 27 participants
27
  90.0%
29
 100.0%
26
  74.3%
21
  84.0%
18
  66.7%
Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 Number Analyzed 30 participants 24 participants 34 participants 25 participants 30 participants
30
 100.0%
22
  91.7%
29
  85.3%
21
  84.0%
24
  80.0%
Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 Number Analyzed 31 participants 29 participants 32 participants 25 participants 27 participants
12
  38.7%
8
  27.6%
9
  28.1%
5
  20.0%
6
  22.2%
Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 Number Analyzed 30 participants 29 participants 35 participants 25 participants 27 participants
29
  96.7%
29
 100.0%
28
  80.0%
22
  88.0%
20
  74.1%
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 Number Analyzed 30 participants 24 participants 34 participants 25 participants 30 participants
17
  56.7%
9
  37.5%
10
  29.4%
5
  20.0%
8
  26.7%
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 Number Analyzed 31 participants 29 participants 32 participants 25 participants 27 participants
1
   3.2%
0
   0.0%
1
   3.1%
0
   0.0%
0
   0.0%
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 Number Analyzed 30 participants 29 participants 35 participants 25 participants 27 participants
18
  60.0%
15
  51.7%
16
  45.7%
9
  36.0%
6
  22.2%
8.Secondary Outcome
Title Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Hide Description Seroprotection rate (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers ≥ 40 against the tested vaccine virus The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Time Frame At Days 0, 42, 385, 392
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 36 33 37 31 35
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/Indonesia/5/2005 H5N1 HI, Day 0 Number Analyzed 36 participants 33 participants 37 participants 31 participants 35 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Flu A/Indonesia/5/2005 H5N1 HI, Day 42 Number Analyzed 36 participants 33 participants 37 participants 31 participants 35 participants
36
 100.0%
33
 100.0%
37
 100.0%
31
 100.0%
35
 100.0%
Flu A/Indonesia/5/2005 H5N1 HI, Day 385 Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
33
  97.1%
26
  78.8%
28
  75.7%
28
  90.3%
23
  71.9%
Flu A/Indonesia/5/2005 H5N1 HI, Day 392 Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
34
 100.0%
33
 100.0%
37
 100.0%
31
 100.0%
32
 100.0%
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0 Number Analyzed 33 participants 30 participants 35 participants 25 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   6.7%
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 Number Analyzed 32 participants 27 participants 36 participants 31 participants 35 participants
32
 100.0%
25
  92.6%
35
  97.2%
28
  90.3%
31
  88.6%
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 Number Analyzed 34 participants 32 participants 34 participants 31 participants 30 participants
9
  26.5%
8
  25.0%
8
  23.5%
7
  22.6%
6
  20.0%
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 Number Analyzed 33 participants 32 participants 36 participants 31 participants 32 participants
30
  90.9%
32
 100.0%
27
  75.0%
27
  87.1%
22
  68.8%
Flu A/Vietnam/1194/2004 H5N1 HI, Day 0 Number Analyzed 33 participants 30 participants 35 participants 25 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   6.7%
Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 Number Analyzed 32 participants 27 participants 36 participants 31 participants 35 participants
32
 100.0%
25
  92.6%
31
  86.1%
26
  83.9%
29
  82.9%
Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 Number Analyzed 34 participants 32 participants 34 participants 31 participants 30 participants
15
  44.1%
10
  31.3%
10
  29.4%
7
  22.6%
8
  26.7%
Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 Number Analyzed 33 participants 32 participants 36 participants 31 participants 32 participants
32
  97.0%
32
 100.0%
29
  80.6%
28
  90.3%
24
  75.0%
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0 Number Analyzed 33 participants 30 participants 35 participants 25 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 Number Analyzed 32 participants 27 participants 36 participants 31 participants 35 participants
19
  59.4%
10
  37.0%
11
  30.6%
7
  22.6%
9
  25.7%
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 Number Analyzed 34 participants 32 participants 34 participants 31 participants 30 participants
1
   2.9%
1
   3.1%
1
   2.9%
0
   0.0%
1
   3.3%
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 Number Analyzed 33 participants 32 participants 36 participants 31 participants 32 participants
20
  60.6%
18
  56.3%
16
  44.4%
10
  32.3%
8
  25.0%
9.Secondary Outcome
Title Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens
Hide Description GMTs were defined as the geometric mean antibody titres calculated on all subjects post the primary immunization (at Day 0, 42, 385) and 7 days post booster dose (at Day 392). The aggregate variables were calculated for each group. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Time Frame At Days 0, 42 and 385 (post the primary immunization), at Day 392 (7 days post booster dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 36 33 37 31 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/Indonesia/5/2005 H5N1 HI, Day 0 Number Analyzed 36 participants 33 participants 37 participants 31 participants 35 participants
5.1
(4.9 to 5.3)
5.1
(4.9 to 5.3)
5.1
(4.9 to 5.4)
5.0
(5.0 to 5.0)
5.6
(4.9 to 6.5)
Flu A/Indonesia/5/2005 H5N1 HI, Day 42 Number Analyzed 36 participants 33 participants 37 participants 31 participants 35 participants
1118.6
(884.4 to 1414.9)
858.8
(659.2 to 1118.8)
913.6
(672.6 to 1241.1)
640.0
(488.3 to 839.0)
568.4
(442.7 to 729.8)
Flu A/Indonesia/5/2005 H5N1 HI, Day 385 Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
98.1
(76.7 to 125.4)
61.5
(47.1 to 80.3)
72.1
(51.6 to 100.7)
79.1
(59.2 to 105.6)
59.6
(45.0 to 79.0)
Flu A/Indonesia/5/2005 H5N1 HI, Day 392 Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
476.2
(348.4 to 650.9)
407.6
(315.0 to 527.4)
305.4
(227.1 to 410.6)
286.2
(216.0 to 379.1)
201.0
(156.1 to 258.7)
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0 Number Analyzed 33 participants 30 participants 35 participants 25 participants 30 participants
5.3
(5.0 to 5.7)
5.4
(4.8 to 5.9)
5.3
(5.0 to 5.7)
5.0
(5.0 to 5.0)
6.1
(4.9 to 7.6)
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 Number Analyzed 32 participants 27 participants 36 participants 31 participants 35 participants
167.1
(128.4 to 217.3)
135.3
(97.6 to 187.5)
109.9
(81.2 to 148.7)
91.5
(70.2 to 119.1)
78.5
(58.5 to 105.3)
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 Number Analyzed 34 participants 32 participants 34 participants 31 participants 30 participants
23.4
(18.8 to 29.2)
20.8
(16.3 to 26.6)
17.8
(13.2 to 24.1)
20.9
(16.1 to 26.9)
19.5
(14.2 to 26.8)
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 Number Analyzed 33 participants 32 participants 36 participants 31 participants 32 participants
125.6
(89.4 to 176.5)
126.1
(95.2 to 167.0)
77.6
(54.5 to 110.4)
70.7
(52.7 to 95.0)
53.5
(38.6 to 74.2)
Flu A/Vietnam/1194/2004 H5N1 HI, Day 0 Number Analyzed 33 participants 30 participants 35 participants 25 participants 30 participants
5.3
(5.0 to 5.7)
5.0
(5.0 to 5.0)
5.1
(4.9 to 5.5)
5.1
(4.9 to 5.4)
5.8
(4.7 to 7.2)
Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 Number Analyzed 32 participants 27 participants 36 participants 31 participants 35 participants
128.9
(103.1 to 161.2)
104.7
(79.0 to 138.6)
88.9
(63.2 to 125.0)
77.2
(59.7 to 99.9)
69.0
(51.7 to 92.0)
Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 Number Analyzed 34 participants 32 participants 34 participants 31 participants 30 participants
26.0
(20.0 to 33.8)
21.5
(16.8 to 27.5)
18.4
(13.2 to 25.7)
21.3
(16.3 to 27.9)
20.6
(14.8 to 28.7)
Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 Number Analyzed 33 participants 32 participants 36 participants 31 participants 32 participants
133.9
(95.5 to 187.7)
137.5
(107.3 to 176.1)
76.2
(53.9 to 107.7)
76.5
(56.8 to 103.1)
57.8
(41.5 to 80.4)
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0 Number Analyzed 33 participants 30 participants 35 participants 25 participants 30 participants
5.3
(4.9 to 5.7)
5.0
(5.0 to 5.0)
5.1
(4.9 to 5.3)
5.2
(4.8 to 5.7)
5.3
(4.9 to 5.8)
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 Number Analyzed 32 participants 27 participants 36 participants 31 participants 35 participants
35.8
(27.9 to 46.0)
27.8
(21.1 to 36.7)
22.8
(17.2 to 30.3)
21.6
(16.7 to 27.8)
19.9
(15.4 to 25.8)
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 Number Analyzed 34 participants 32 participants 34 participants 31 participants 30 participants
9.2
(7.6 to 11.2)
8.0
(6.4 to 9.9)
7.4
(6.0 to 9.0)
7.7
(6.6 to 9.1)
7.2
(5.8 to 8.8)
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 Number Analyzed 33 participants 32 participants 36 participants 31 participants 32 participants
42.6
(29.8 to 60.8)
37.0
(27.1 to 50.6)
24.0
(17.1 to 33.6)
22.6
(16.7 to 30.5)
17.9
(13.4 to 23.9)
10.Secondary Outcome
Title Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains
Hide Description MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 42) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Time Frame At Day 42 (relative to Day 0), at Day 385 (relative to Day 0) and at Day 392 (relative to Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 36 33 37 31 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold change
Flu A/Indonesia/5/2005 H5N1 HI, Day 42 Number Analyzed 36 participants 33 participants 37 participants 31 participants 35 participants
219.5
(172.6 to 279.0)
168.2
(127.4 to 222.0)
177.7
(131.5 to 240.1)
128.0
(97.7 to 167.8)
101.0
(74.8 to 136.4)
Flu A/Indonesia/5/2005 H5N1 HI, Day 385 Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
19.2
(14.8 to 24.9)
12.0
(9.2 to 15.8)
14.0
(10.0 to 19.7)
15.8
(11.8 to 21.1)
10.5
(7.6 to 14.5)
Flu A/Indonesia/5/2005 H5N1 HI, Day 392 Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
93.3
(67.9 to 128.3)
79.8
(61.5 to 103.5)
59.4
(44.5 to 79.4)
57.2
(43.2 to 75.8)
35.3
(25.9 to 48.1)
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 Number Analyzed 32 participants 27 participants 36 participants 31 participants 35 participants
31.3
(23.5 to 41.6)
22.9
(17.2 to 30.6)
20.4
(14.9 to 28.1)
18.9
(14.0 to 25.5)
12.6
(9.0 to 17.6)
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 Number Analyzed 34 participants 32 participants 34 participants 31 participants 30 participants
4.2
(3.3 to 5.3)
3.6
(2.9 to 4.6)
3.3
(2.4 to 4.5)
3.9
(2.9 to 5.3)
3.3
(2.3 to 4.7)
Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 Number Analyzed 33 participants 32 participants 36 participants 31 participants 32 participants
23.4
(16.2 to 33.9)
22.9
(17.1 to 30.7)
14.5
(10.1 to 20.7)
13.9
(9.8 to 19.8)
9.1
(6.0 to 13.7)
Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 Number Analyzed 32 participants 27 participants 36 participants 31 participants 35 participants
24.3
(19.0 to 31.0)
20.1
(15.2 to 26.7)
16.7
(11.7 to 23.8)
15.1
(11.1 to 20.6)
11.4
(8.4 to 15.6)
Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 Number Analyzed 34 participants 32 participants 34 participants 31 participants 30 participants
4.7
(3.5 to 6.2)
4.1
(3.1 to 5.3)
3.5
(2.5 to 5.0)
3.9
(2.8 to 5.4)
3.6
(2.6 to 5.2)
Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 Number Analyzed 33 participants 32 participants 36 participants 31 participants 32 participants
25.1
(17.3 to 36.4)
27.1
(20.9 to 35.0)
14.5
(10.2 to 20.5)
14.5
(10.0 to 21.1)
10.1
(6.7 to 15.2)
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 Number Analyzed 32 participants 27 participants 36 participants 31 participants 35 participants
6.7
(5.0 to 9.0)
5.5
(4.0 to 7.4)
4.3
(3.2 to 5.8)
4.1
(3.0 to 5.6)
3.5
(2.7 to 4.6)
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 Number Analyzed 34 participants 32 participants 34 participants 31 participants 30 participants
1.7
(1.4 to 2.1)
1.5
(1.2 to 1.8)
1.4
(1.2 to 1.8)
1.5
(1.2 to 1.8)
1.3
(1.1 to 1.6)
Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 Number Analyzed 33 participants 32 participants 36 participants 31 participants 32 participants
8.1
(5.5 to 12.0)
7.1
(5.1 to 9.9)
4.7
(3.3 to 6.7)
4.2
(3.0 to 6.0)
3.2
(2.3 to 4.3)
11.Secondary Outcome
Title Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains.
Hide Description MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 385) reciprocal MN titer to the pre-vaccination (Day 0) reciprocal MN titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
Time Frame At Day 385 (relative to Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 34 32 37 30 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold change
Flu A/Indonesia/5/2005 H5N1 MN Number Analyzed 34 participants 32 participants 37 participants 29 participants 32 participants
17.5
(13.7 to 22.4)
14.8
(12.6 to 17.5)
15.3
(12.5 to 18.6)
17.8
(14.3 to 22.1)
14.2
(11.8 to 17.1)
Flu A/Vietnam/1194/2004 H5N1 MN Number Analyzed 31 participants 32 participants 35 participants 30 participants 32 participants
7.6
(5.5 to 10.3)
5.8
(4.2 to 8.1)
5.4
(4.0 to 7.4)
7.5
(5.8 to 9.8)
6.1
(4.5 to 8.3)
Flu A/duck/Bangladesh/19097/2013 H5N1 MN Number Analyzed 33 participants 32 participants 37 participants 30 participants 32 participants
7.0
(5.2 to 9.4)
5.5
(4.1 to 7.3)
5.3
(3.8 to 7.3)
6.9
(5.0 to 9.4)
4.2
(3.1 to 5.8)
12.Secondary Outcome
Title Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens
Hide Description MN antibody titers were expressed as Geometric Mean Titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
Time Frame At Days 0, 42, 385 and Day 392
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 36 33 37 31 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/Indonesia/5/2005 H5N1 MN, Day 0 Number Analyzed 36 participants 32 participants 37 participants 29 participants 35 participants
14.3
(13.7 to 14.8)
14.0
(14.0 to 14.0)
14.0
(14.0 to 14.0)
14.0
(14.0 to 14.0)
14.0
(14.0 to 14.0)
Flu A/Indonesia/5/2005 H5N1 MN, Day 42 Number Analyzed 36 participants 32 participants 37 participants 31 participants 35 participants
1498.5
(1181.7 to 1900.1)
1214.3
(921.3 to 1600.6)
1211.6
(881.3 to 1665.9)
707.1
(533.1 to 937.9)
727.4
(545.9 to 969.2)
Flu A/Indonesia/5/2005 H5N1 MN, Day 385 Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
250.3
(197.1 to 318.0)
203.6
(172.8 to 239.8)
213.8
(175.2 to 260.9)
247.2
(201.4 to 303.5)
198.5
(165.1 to 238.7)
Flu A/Indonesia/5/2005 H5N1 MN, Day 392 Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
1085.0
(767.5 to 1533.9)
969.1
(710.1 to 1322.6)
674.2
(492.3 to 923.3)
681.0
(496.3 to 934.4)
489.6
(381.7 to 628.0)
Flu A/Vietnam/1194/2004 H5N1 MN, Day 0 Number Analyzed 34 participants 32 participants 37 participants 30 participants 35 participants
14.6
(13.8 to 15.4)
14.6
(13.7 to 15.5)
14.8
(13.6 to 16.1)
14.0
(14.0 to 14.0)
15.2
(13.5 to 17.0)
Flu A/Vietnam/1194/2004 H5N1 MN, Day 42 Number Analyzed 36 participants 33 participants 37 participants 31 participants 35 participants
217.6
(187.7 to 252.2)
195.2
(156.7 to 243.1)
177.3
(147.8 to 212.7)
176.9
(139.0 to 225.2)
149.3
(117.6 to 189.6)
Flu A/Vietnam/1194/2004 H5N1 MN, Day 385 Number Analyzed 33 participants 33 participants 35 participants 31 participants 32 participants
113.0
(85.3 to 149.9)
88.0
(64.0 to 121.0)
80.7
(58.7 to 111.1)
103.6
(80.5 to 133.2)
89.0
(67.2 to 118.0)
Flu A/Vietnam/1194/2004 H5N1 MN, Day 392 Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
320.0
(259.8 to 394.1)
256.6
(212.5 to 309.9)
239.2
(202.5 to 282.7)
270.4
(237.2 to 308.3)
216.5
(179.0 to 261.8)
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 0 Number Analyzed 35 participants 32 participants 37 participants 31 participants 35 participants
14.6
(13.8 to 15.4)
14.3
(13.7 to 15.0)
14.5
(13.5 to 15.7)
14.6
(13.7 to 15.6)
15.2
(13.8 to 16.7)
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42 Number Analyzed 36 participants 33 participants 37 participants 31 participants 35 participants
179.4
(146.5 to 219.7)
161.6
(129.4 to 201.9)
147.1
(116.6 to 185.7)
161.8
(129.1 to 202.8)
140.6
(111.8 to 176.8)
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385 Number Analyzed 34 participants 33 participants 37 participants 30 participants 32 participants
102.0
(76.6 to 135.9)
79.2
(59.3 to 105.8)
76.3
(55.7 to 104.7)
100.7
(74.2 to 136.6)
63.0
(47.0 to 84.4)
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392 Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
262.5
(212.2 to 324.7)
240.9
(197.7 to 293.6)
194.8
(157.7 to 240.7)
202.2
(167.8 to 243.7)
174.5
(140.5 to 216.8)
13.Secondary Outcome
Title Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains.
Hide Description VRR for MN was defined as the incidence rate of subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to pre vaccination titers. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
Time Frame At Day 42, Day 385 (relative to Day 0), Day 392 (relative to Day 0) and D 392 (relative to Day 385)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 36 33 37 31 35
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/Indonesia/5/2005 H5N1 MN, Day 42 Number Analyzed 36 participants 32 participants 37 participants 29 participants 35 participants
36
 100.0%
31
  96.9%
37
 100.0%
29
 100.0%
35
 100.0%
Flu A/Indonesia/5/2005 H5N1 MN, Day 385 Number Analyzed 34 participants 33 participants 37 participants 29 participants 32 participants
34
 100.0%
32
  97.0%
37
 100.0%
29
 100.0%
32
 100.0%
Flu A/Indonesia/5/2005 H5N1 MN, Day 392 Number Analyzed 34 participants 33 participants 37 participants 29 participants 32 participants
34
 100.0%
32
  97.0%
37
 100.0%
29
 100.0%
32
 100.0%
Flu A/Indonesia/5/2005 H5N1 MN, D 392 Number Analyzed 34 participants 33 participants 37 participants 31 participants 32 participants
21
  61.8%
24
  72.7%
14
  37.8%
15
  48.4%
13
  40.6%
Flu A/Vietnam/1194/2004 H5N1 MN, Day 42 Number Analyzed 34 participants 32 participants 37 participants 30 participants 35 participants
34
 100.0%
31
  96.9%
36
  97.3%
29
  96.7%
32
  91.4%
Flu A/Vietnam/1194/2004 H5N1 MN, Day 385 Number Analyzed 31 participants 32 participants 35 participants 30 participants 32 participants
27
  87.1%
27
  84.4%
27
  77.1%
28
  93.3%
25
  78.1%
Flu A/Vietnam/1194/2004 H5N1 MN, Day 392 Number Analyzed 32 participants 32 participants 37 participants 30 participants 32 participants
31
  96.9%
31
  96.9%
37
 100.0%
30
 100.0%
30
  93.8%
Flu A/Vietnam/1194/2004 H5N1 MN, D 392 Number Analyzed 33 participants 33 participants 35 participants 31 participants 32 participants
10
  30.3%
10
  30.3%
10
  28.6%
7
  22.6%
6
  18.8%
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42 Number Analyzed 35 participants 32 participants 37 participants 31 participants 35 participants
34
  97.1%
31
  96.9%
35
  94.6%
31
 100.0%
32
  91.4%
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385 Number Analyzed 33 participants 32 participants 37 participants 30 participants 32 participants
28
  84.8%
27
  84.4%
29
  78.4%
25
  83.3%
23
  71.9%
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392 Number Analyzed 33 participants 32 participants 37 participants 31 participants 32 participants
33
 100.0%
32
 100.0%
36
  97.3%
31
 100.0%
30
  93.8%
Flu A/duck/Bangladesh/19097/2013 H5N1 MN, D 392 Number Analyzed 34 participants 33 participants 37 participants 30 participants 32 participants
9
  26.5%
10
  30.3%
8
  21.6%
6
  20.0%
9
  28.1%
14.Secondary Outcome
Title Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen.
Hide Description Antigen-specific CD4+/CD8+ T Cells identified as CD4/CD8+ were analysed for T cells expressing two or more of the following immune markers: CD40 Ligand, Interleukin (IL)-2, Tumor Necrosis Factor alpha (TNF-a), Interferon-gamma (IFN-g). The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells repsectively. All doubles = T cell expressing at least 2 cytokines.
Time Frame At Days 0, 42, 385 and 392
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort (CMI sub-cohort) which included all vaccinated subjects for whom data were available. The CMI sub-cohort included approximately 20 vaccinated subjects per group.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 20 19 19 18 19
Median (Inter-Quartile Range)
Unit of Measure: cells/million T cells
CD4 dble_All (Polypositives), Day 0 Number Analyzed 20 participants 19 participants 17 participants 18 participants 19 participants
55.5
(1.0 to 227.0)
42.0
(3.0 to 185.0)
43.0
(1.0 to 90.0)
89.5
(26.0 to 217.0)
74.0
(1.0 to 277.0)
CD4 dble_All (Polypositives), Day 42 Number Analyzed 18 participants 19 participants 17 participants 16 participants 16 participants
2711.0
(1669.0 to 5165.0)
1629.0
(707.0 to 4301.0)
960.0
(432.0 to 1379.0)
1337.5
(748.0 to 2793.0)
1372.5
(426.5 to 2911.5)
CD4 dble_All (Polypositives), Day 385 Number Analyzed 20 participants 18 participants 18 participants 18 participants 17 participants
1530.0
(632.5 to 2293.5)
1255.0
(560.0 to 2096.0)
1413.0
(469.0 to 1834.0)
954.0
(495.0 to 1199.0)
596.0
(373.0 to 1167.0)
CD4 dble_All (Polypositives), Day 392 Number Analyzed 20 participants 17 participants 19 participants 18 participants 17 participants
1417.0
(759.5 to 3955.5)
1129.0
(582.0 to 3221.0)
731.0
(448.0 to 1461.0)
722.5
(260.0 to 907.0)
832.0
(345.0 to 1497.0)
CD4 dble_CD40L, Day 0 Number Analyzed 20 participants 19 participants 17 participants 18 participants 19 participants
23.0
(1.0 to 56.0)
19.0
(1.0 to 52.0)
5.0
(1.0 to 60.0)
36.0
(1.0 to 85.0)
26.0
(1.0 to 133.0)
CD4 dble_CD40L, Day 42 Number Analyzed 18 participants 19 participants 17 participants 16 participants 16 participants
1671.0
(635.0 to 3256.0)
1341.0
(378.0 to 2696.0)
514.0
(229.0 to 1200.0)
516.0
(307.5 to 2031.0)
717.0
(295.5 to 1604.5)
CD4 dble_CD40L, Day 385 Number Analyzed 20 participants 18 participants 18 participants 18 participants 17 participants
1074.0
(562.5 to 2637.0)
844.0
(425.0 to 1660.0)
722.0
(323.0 to 1524.0)
315.0
(148.0 to 511.0)
588.0
(154.0 to 902.0)
CD4 dble_CD40L, Day 392 Number Analyzed 20 participants 17 participants 19 participants 18 participants 17 participants
1130.5
(801.0 to 3108.5)
986.0
(340.0 to 1802.0)
660.0
(213.0 to 1706.0)
424.0
(239.0 to 645.0)
325.0
(110.0 to 939.0)
CD4 dble_IFNγ, Day 0 Number Analyzed 20 participants 19 participants 17 participants 18 participants 19 participants
47.0
(4.0 to 391.0)
49.0
(1.0 to 352.0)
24.0
(1.0 to 118.0)
40.5
(1.0 to 681.0)
12.0
(1.0 to 259.0)
CD4 dble_IFNγ, Day 42 Number Analyzed 18 participants 19 participants 17 participants 16 participants 16 participants
803.0
(260.0 to 1627.0)
406.0
(304.0 to 1481.0)
266.0
(206.0 to 394.0)
863.5
(352.5 to 1229.5)
437.5
(158.5 to 1027.0)
CD4 dble_IFNγ, Day 385 Number Analyzed 20 participants 18 participants 18 participants 18 participants 17 participants
200.0
(80.0 to 510.0)
316.5
(70.0 to 569.0)
248.5
(56.0 to 557.0)
589.5
(216.0 to 830.0)
163.0
(62.0 to 355.0)
CD4 dble_IFNγ, Day 392 Number Analyzed 20 participants 17 participants 19 participants 18 participants 17 participants
459.5
(127.0 to 941.5)
329.0
(109.0 to 784.0)
123.0
(74.0 to 465.0)
423.5
(147.0 to 919.0)
253.0
(112.0 to 608.0)
CD4 dble_IL2, Day 0 Number Analyzed 20 participants 19 participants 17 participants 18 participants 19 participants
89.5
(1.0 to 136.5)
72.0
(27.0 to 183.0)
50.0
(1.0 to 76.0)
47.0
(3.0 to 133.0)
75.0
(1.0 to 223.0)
CD4 dble_IL2, Day 42 Number Analyzed 18 participants 19 participants 17 participants 16 participants 16 participants
3399.5
(1593.0 to 5907.0)
2438.0
(759.0 to 6212.0)
1344.0
(508.0 to 1859.0)
1448.0
(1012.5 to 2993.5)
1761.5
(577.5 to 3085.5)
CD4 dble_IL2, Day 385 Number Analyzed 20 participants 18 participants 18 participants 18 participants 17 participants
1676.5
(779.5 to 2551.5)
1394.0
(531.0 to 2151.0)
1366.5
(460.0 to 1938.0)
870.5
(458.0 to 1223.0)
621.0
(410.0 to 1556.0)
CD4 dble_IL2, Day 392 Number Analyzed 20 participants 17 participants 19 participants 18 participants 17 participants
1502.5
(864.5 to 3500.0)
1455.0
(672.0 to 3065.0)
893.0
(627.0 to 1494.0)
840.0
(192.0 to 1067.0)
882.0
(338.0 to 1181.0)
CD4 dble_TNFα, Day 0 Number Analyzed 20 participants 19 participants 17 participants 18 participants 19 participants
49.5
(1.0 to 322.0)
98.0
(1.0 to 249.0)
62.0
(1.0 to 192.0)
52.0
(23.0 to 249.0)
71.0
(29.0 to 296.0)
CD4 dble_TNFα, Day 42 Number Analyzed 18 participants 19 participants 17 participants 16 participants 16 participants
3023.0
(917.0 to 4946.0)
1970.0
(569.0 to 4382.0)
840.0
(705.0 to 1446.0)
1353.0
(723.0 to 2501.0)
1204.5
(582.5 to 2853.0)
CD4 dble_TNFα, Day 385 Number Analyzed 20 participants 18 participants 18 participants 18 participants 17 participants
1339.0
(765.0 to 2419.5)
1233.0
(696.0 to 2030.0)
1277.5
(419.0 to 1921.0)
1097.5
(547.0 to 1517.0)
678.0
(463.0 to 1251.0)
CD4 dble_TNFα, Day 392 Number Analyzed 20 participants 17 participants 19 participants 18 participants 17 participants
1743.5
(741.5 to 3863.0)
1257.0
(504.0 to 2468.0)
740.0
(394.0 to 1266.0)
726.5
(433.0 to 1315.0)
908.0
(620.0 to 1579.0)
CD8 dble_All (Polypositives), Day 0 Number Analyzed 20 participants 19 participants 17 participants 18 participants 19 participants
3.5
(1.0 to 68.5)
5.0
(1.0 to 45.0)
30.0
(1.0 to 40.0)
47.0
(1.0 to 121.0)
1.0
(1.0 to 58.0)
CD8 dble_All (Polypositives), Day 42 Number Analyzed 17 participants 19 participants 17 participants 16 participants 15 participants
48.0
(2.0 to 186.0)
63.0
(42.0 to 238.0)
45.0
(1.0 to 83.0)
125.0
(54.5 to 220.5)
128.0
(10.0 to 323.0)
CD8 dble_All (Polypositives), Day 385 Number Analyzed 20 participants 18 participants 19 participants 18 participants 17 participants
33.5
(1.0 to 108.5)
62.5
(1.0 to 147.0)
1.0
(1.0 to 107.0)
56.0
(1.0 to 194.0)
1.0
(1.0 to 79.0)
CD8 dble_All (Polypositives), Day 392 Number Analyzed 19 participants 17 participants 19 participants 18 participants 17 participants
63.0
(1.0 to 200.0)
33.0
(1.0 to 88.0)
25.0
(1.0 to 70.0)
60.5
(1.0 to 126.0)
26.0
(1.0 to 99.0)
CD8 dble_CD40L, Day 0 Number Analyzed 20 participants 19 participants 17 participants 18 participants 19 participants
1.0
(1.0 to 72.5)
1.0
(1.0 to 21.0)
1.0
(1.0 to 37.0)
46.0
(1.0 to 75.0)
1.0
(1.0 to 57.0)
CD8 dble_CD40L, Day 42 Number Analyzed 17 participants 19 participants 17 participants 16 participants 15 participants
108.0
(7.0 to 147.0)
25.0
(1.0 to 100.0)
1.0
(1.0 to 68.0)
7.5
(1.0 to 60.0)
83.0
(1.0 to 186.0)
CD8 dble_CD40L, Day 385 Number Analyzed 20 participants 18 participants 19 participants 18 participants 17 participants
88.0
(1.0 to 197.5)
70.5
(11.0 to 132.0)
53.0
(1.0 to 93.0)
4.0
(1.0 to 116.0)
1.0
(1.0 to 31.0)
CD8 dble_CD40L, Day 392 Number Analyzed 19 participants 17 participants 19 participants 18 participants 17 participants
40.0
(1.0 to 244.0)
18.0
(1.0 to 95.0)
14.0
(1.0 to 140.0)
80.0
(1.0 to 135.0)
10.0
(1.0 to 55.0)
CD8 dble_IFNγ, Day 0 Number Analyzed 20 participants 19 participants 17 participants 18 participants 19 participants
41.5
(1.0 to 148.0)
33.0
(1.0 to 64.0)
22.0
(1.0 to 53.0)
78.0
(28.0 to 166.0)
1.0
(1.0 to 138.0)
CD8 dble_IFNγ, Day 42 Number Analyzed 17 participants 19 participants 17 participants 16 participants 15 participants
32.0
(1.0 to 129.0)
77.0
(1.0 to 321.0)
67.0
(1.0 to 116.0)
191.5
(60.5 to 329.0)
131.0
(1.0 to 243.0)
CD8 dble_IFNγ, Day 385 Number Analyzed 20 participants 18 participants 19 participants 18 participants 17 participants
99.5
(2.5 to 348.0)
103.0
(1.0 to 322.0)
31.0
(1.0 to 170.0)
165.5
(64.0 to 445.0)
1.0
(1.0 to 251.0)
CD8 dble_IFNγ, Day 392 Number Analyzed 19 participants 17 participants 19 participants 18 participants 17 participants
52.0
(2.0 to 364.0)
174.0
(56.0 to 484.0)
31.0
(1.0 to 206.0)
119.0
(16.0 to 431.0)
28.0
(1.0 to 366.0)
CD8 dble_IL2, Day 0 Number Analyzed 20 participants 19 participants 17 participants 18 participants 19 participants
1.0
(1.0 to 66.0)
22.0
(1.0 to 104.0)
1.0
(1.0 to 49.0)
1.0
(1.0 to 90.0)
1.0
(1.0 to 94.0)
CD8 dble_IL2, Day 42 Number Analyzed 17 participants 19 participants 17 participants 16 participants 15 participants
1.0
(1.0 to 168.0)
48.0
(1.0 to 197.0)
53.0
(1.0 to 166.0)
65.5
(1.0 to 263.0)
1.0
(1.0 to 186.0)
CD8 dble_IL2, Day 385 Number Analyzed 20 participants 18 participants 19 participants 18 participants 17 participants
1.0
(1.0 to 125.0)
32.5
(1.0 to 218.0)
16.0
(1.0 to 111.0)
14.0
(1.0 to 117.0)
1.0
(1.0 to 94.0)
CD8 dble_IL2, Day 392 Number Analyzed 19 participants 17 participants 19 participants 18 participants 17 participants
63.0
(1.0 to 451.0)
99.0
(22.0 to 292.0)
1.0
(1.0 to 70.0)
64.0
(1.0 to 156.0)
45.0
(1.0 to 77.0)
CD8 dble_TNFα, Day 0 Number Analyzed 20 participants 19 participants 17 participants 18 participants 19 participants
120.5
(1.0 to 553.0)
103.0
(1.0 to 516.0)
34.0
(1.0 to 324.0)
163.5
(48.0 to 614.0)
116.0
(1.0 to 521.0)
CD8 dble_TNFα, Day 42 Number Analyzed 17 participants 19 participants 17 participants 16 participants 15 participants
192.0
(52.0 to 485.0)
396.0
(77.0 to 709.0)
125.0
(24.0 to 294.0)
351.5
(153.5 to 970.5)
756.0
(65.0 to 1557.0)
CD8 dble_TNFα, Day 385 Number Analyzed 20 participants 18 participants 19 participants 18 participants 17 participants
77.5
(15.0 to 477.5)
366.5
(1.0 to 559.0)
81.0
(1.0 to 204.0)
301.5
(29.0 to 641.0)
212.0
(85.0 to 411.0)
CD8 dble_TNFα, Day 392 Number Analyzed 19 participants 17 participants 19 participants 18 participants 17 participants
217.0
(36.0 to 699.0)
130.0
(1.0 to 708.0)
121.0
(26.0 to 238.0)
310.0
(68.0 to 953.0)
207.0
(47.0 to 369.0)
15.Secondary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms
Hide Description Solicited local AEs assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 38 37 38 37 35
Measure Type: Count of Participants
Unit of Measure: Participants
Pain, Any
20
  52.6%
15
  40.5%
16
  42.1%
20
  54.1%
17
  48.6%
Pain, Grade 3
2
   5.3%
1
   2.7%
1
   2.6%
1
   2.7%
2
   5.7%
Redness (mm), Any
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Redness (mm), Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Swelling (mm), Any
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.7%
0
   0.0%
Swelling (mm), Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Duration of Solicited Local Symptoms
Hide Description Duration was defined as number of days with any grade of local symptoms.
Time Frame During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 38 37 38 37 35
Median (Inter-Quartile Range)
Unit of Measure: Days
Pain, Dose 1 Number Analyzed 11 participants 10 participants 11 participants 13 participants 12 participants
3.0
(1.0 to 4.0)
2.0
(1.0 to 3.0)
1.0
(1.0 to 2.0)
1.0
(1.0 to 2.0)
1.0
(1.0 to 2.0)
Pain, Dose 2 Number Analyzed 11 participants 9 participants 10 participants 8 participants 12 participants
2.0
(1.0 to 3.0)
2.0
(1.0 to 2.0)
1.5
(1.0 to 2.0)
1.5
(1.0 to 2.0)
1.0
(1.0 to 2.5)
Pain, Dose 3 Number Analyzed 17 participants 13 participants 10 participants 10 participants 12 participants
1.0
(1.0 to 2.0)
1.0
(1.0 to 2.0)
2.0
(1.0 to 2.0)
2.0
(1.0 to 3.0)
1.5
(1.0 to 2.0)
Swelling, Dose 1 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants
3.0
(3.0 to 3.0)
17.Secondary Outcome
Title Number of Subjects Reporting Solicited General Symptoms.
Hide Description Assessed solicited general symptoms were fever (defined as temperature ≥ 38.0 degrees Celsius (°C) assessed by any route (oral, axillary, rectal)], irritability/fussiness, drowsiness and. loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 irritability/Fussiness and Drowsiness = Prevented normal activity, Grade3 Loss of appetite = Did not eat at all. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination
Time Frame During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 38 37 38 37 35
Measure Type: Count of Participants
Unit of Measure: Participants
Drowsiness, Any
25
  65.8%
18
  48.6%
13
  34.2%
17
  45.9%
16
  45.7%
Drowsiness, Grade 3
2
   5.3%
3
   8.1%
1
   2.6%
1
   2.7%
0
   0.0%
Drowsiness, Related
22
  57.9%
14
  37.8%
12
  31.6%
13
  35.1%
14
  40.0%
Irritability / Fussiness, Any
24
  63.2%
17
  45.9%
19
  50.0%
22
  59.5%
21
  60.0%
Irritability / Fussiness, Grade 3
3
   7.9%
2
   5.4%
3
   7.9%
2
   5.4%
0
   0.0%
Irritability / Fussiness, Related
22
  57.9%
14
  37.8%
17
  44.7%
16
  43.2%
19
  54.3%
Loss Of Appetite, Any
24
  63.2%
13
  35.1%
14
  36.8%
20
  54.1%
13
  37.1%
Loss Of Appetite, Grade 3
0
   0.0%
1
   2.7%
2
   5.3%
2
   5.4%
0
   0.0%
Loss Of Appetite, Related
21
  55.3%
7
  18.9%
11
  28.9%
15
  40.5%
10
  28.6%
Temperature/(Axillary) (°C), Any
24
  63.2%
17
  45.9%
14
  36.8%
14
  37.8%
10
  28.6%
Temperature/(Axillary) (°C), Grade 3
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
Temperature/(Axillary) (°C), Related
22
  57.9%
12
  32.4%
12
  31.6%
14
  37.8%
10
  28.6%
18.Secondary Outcome
Title Duration of Solicited General Symptoms.
Hide Description Duration was defined as number of days with any grade of general symptoms.
Time Frame During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 38 37 38 37 35
Median (Inter-Quartile Range)
Unit of Measure: Days
Drowsiness, Dose 1 Number Analyzed 15 participants 10 participants 7 participants 10 participants 11 participants
2.0
(1.0 to 3.0)
1.5
(1.0 to 3.0)
2.0
(1.0 to 2.0)
2.0
(1.0 to 3.0)
1.0
(1.0 to 2.0)
Drowsiness, Dose 2 Number Analyzed 15 participants 12 participants 8 participants 9 participants 6 participants
1.0
(1.0 to 2.0)
2.0
(1.0 to 2.5)
2.0
(2.0 to 3.5)
2.0
(1.0 to 2.0)
1.5
(1.0 to 2.0)
Drowsiness, Dose 3 Number Analyzed 11 participants 7 participants 5 participants 10 participants 7 participants
2.0
(1.0 to 2.0)
2.0
(2.0 to 2.0)
2.0
(2.0 to 2.0)
2.5
(1.0 to 4.0)
1.0
(1.0 to 3.0)
Irritability / fussiness, Dose 1 Number Analyzed 13 participants 9 participants 11 participants 13 participants 12 participants
2.0
(1.0 to 3.0)
2.0
(1.0 to 2.0)
1.0
(1.0 to 2.0)
2.0
(1.0 to 4.0)
2.0
(1.0 to 2.0)
Irritability / fussiness, Dose 2 Number Analyzed 17 participants 12 participants 12 participants 12 participants 16 participants
2.0
(1.0 to 3.0)
2.0
(1.0 to 3.0)
2.0
(1.0 to 4.0)
2.0
(1.0 to 4.0)
2.0
(1.0 to 3.0)
Irritability / fussiness, Dose 3 Number Analyzed 8 participants 5 participants 8 participants 10 participants 10 participants
2.0
(2.0 to 3.0)
3.0
(2.0 to 3.0)
1.0
(1.0 to 2.0)
4.0
(3.0 to 5.0)
1.5
(1.0 to 3.0)
Loss of appetite, Dose 1 Number Analyzed 12 participants 5 participants 9 participants 10 participants 8 participants
2.0
(1.0 to 2.5)
3.0
(3.0 to 3.0)
2.0
(1.0 to 3.0)
2.5
(2.0 to 5.0)
1.5
(1.0 to 2.5)
Loss of appetite, Dose 2 Number Analyzed 14 participants 7 participants 7 participants 9 participants 6 participants
2.0
(1.0 to 6.0)
2.0
(1.0 to 2.0)
3.0
(2.0 to 4.0)
2.0
(1.0 to 3.0)
2.0
(1.0 to 3.0)
Loss of appetite, Dose 3 Number Analyzed 12 participants 4 participants 4 participants 11 participants 5 participants
2.0
(1.0 to 3.5)
2.5
(1.5 to 4.5)
2.0
(1.5 to 3.0)
3.0
(2.0 to 4.0)
2.0
(1.0 to 3.0)
Temperature, Dose 1 Number Analyzed 11 participants 5 participants 3 participants 7 participants 5 participants
1.0
(1.0 to 1.0)
2.0
(1.0 to 2.0)
1.0
(1.0 to 2.0)
2.0
(1.0 to 4.0)
1.0
(1.0 to 1.0)
Temperature, Dose 2 Number Analyzed 18 participants 12 participants 9 participants 8 participants 8 participants
1.0
(1.0 to 3.0)
1.0
(1.0 to 1.5)
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.5)
1.0
(1.0 to 1.0)
Temperature, Dose 3 Number Analyzed 4 participants 4 participants 3 participants 3 participants 0 participants
1.0
(1.0 to 1.5)
2.0
(1.0 to 3.0)
1.0
(1.0 to 1.0)
3.0
(2.0 to 4.0)
19.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination.
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame During the 21-day follow-up period (Day 0-Day 20) after each vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 38 37 38 37 35
Measure Type: Count of Participants
Unit of Measure: Participants
Any
21
  55.3%
20
  54.1%
23
  60.5%
20
  54.1%
21
  60.0%
Grade 3
3
   7.9%
1
   2.7%
1
   2.6%
3
   8.1%
5
  14.3%
Related
2
   5.3%
0
   0.0%
1
   2.6%
1
   2.7%
3
   8.6%
20.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame During the 30-day (Day 385-Day 415) follow-up period after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 36 34 38 35 33
Measure Type: Count of Participants
Unit of Measure: Participants
Any
16
  44.4%
8
  23.5%
16
  42.1%
19
  54.3%
14
  42.4%
Grade 3
1
   2.8%
0
   0.0%
0
   0.0%
1
   2.9%
0
   0.0%
Related
1
   2.8%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
21.Secondary Outcome
Title Number of Subjects Reporting Medically Attended Events (MAEs)
Hide Description MAEs are adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as at least 1 MAE experienced.
Time Frame During the entire study period (Day 0 to Day 415 approximately)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 38 37 38 37 35
Measure Type: Count of Participants
Unit of Measure: Participants
Any
29
  76.3%
28
  75.7%
33
  86.8%
27
  73.0%
26
  74.3%
Related
1
   2.6%
0
   0.0%
0
   0.0%
1
   2.7%
0
   0.0%
22.Secondary Outcome
Title Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. “Any pIMD” = at least one pIMD experienced by the study subject. Related = pIMD assessed by the investigator to be causally related to the study vaccination.
Time Frame During the entire study period (Day 0 to Day 415 approximately)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 38 37 38 37 35
Measure Type: Count of Participants
Unit of Measure: Participants
Any
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
Related
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
23.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs)
Hide Description A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time Frame During the entire study period (Day 0 to Day 415 approximately)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 38 37 38 37 35
Measure Type: Count of Participants
Unit of Measure: Participants
Any
5
  13.2%
6
  16.2%
10
  26.3%
4
  10.8%
4
  11.4%
Related
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
24.Secondary Outcome
Title Number of Subjects Reporting Adverse Events of Special Interest (AESI)
Hide Description AESI are a subset of adverse events defined in the Committee for Medicinal Products for Human Use (CHMP) Risk Management Plan for Pandemic Vaccines for safety monitoring.
Time Frame During the entire study period (Day 0 to Day 415 approximately)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description:
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Number of Participants Analyzed 38 37 38 37 35
Measure Type: Count of Participants
Unit of Measure: Participants
Any
4
  10.5%
3
   8.1%
3
   7.9%
2
   5.4%
2
   5.7%
Related
1
   2.6%
0
   0.0%
1
   2.6%
1
   2.7%
0
   0.0%
Time Frame Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately).
Adverse Event Reporting Description The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
 
Arm/Group Title H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Hide Arm/Group Description Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh. Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh. Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh. Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh. Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
All-Cause Mortality
H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)      0/37 (0.00%)      0/38 (0.00%)      0/37 (0.00%)      0/35 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/38 (13.16%)      6/37 (16.22%)      10/38 (26.32%)      4/37 (10.81%)      4/35 (11.43%)    
Gastrointestinal disorders           
Abdominal hernia  1  0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Vomiting   0/38 (0.00%)  0 1/37 (2.70%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Infections and infestations           
Bacteraemia   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Bacterial infection   1/38 (2.63%)  1 1/37 (2.70%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Bronchiolitis   0/38 (0.00%)  0 1/37 (2.70%)  1 1/38 (2.63%)  1 1/37 (2.70%)  1 0/35 (0.00%)  0
Bronchitis   1/38 (2.63%)  1 1/37 (2.70%)  1 1/38 (2.63%)  1 0/37 (0.00%)  0 1/35 (2.86%)  1
Conjunctivitis   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Croup infectious   1/38 (2.63%)  1 1/37 (2.70%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Diarrhoea infectious   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Gastroenteritis   0/38 (0.00%)  0 0/37 (0.00%)  0 3/38 (7.89%)  3 1/37 (2.70%)  1 1/35 (2.86%)  1
Herpangina   1/38 (2.63%)  1 1/37 (2.70%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Influenza   1/38 (2.63%)  1 1/37 (2.70%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Nasopharyngitis   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Oral herpes   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Pneumonia   0/38 (0.00%)  0 2/37 (5.41%)  2 3/38 (7.89%)  3 1/37 (2.70%)  1 0/35 (0.00%)  0
Pneumonia respiratory syncytial viral   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Pneumonia viral   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Respiratory syncytial virus bronchiolitis   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Respiratory syncytial virus bronchitis   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Respiratory syncytial virus infection   1/38 (2.63%)  1 0/37 (0.00%)  0 2/38 (5.26%)  2 0/37 (0.00%)  0 0/35 (0.00%)  0
Scarlet fever   0/38 (0.00%)  0 0/37 (0.00%)  0 2/38 (5.26%)  2 0/37 (0.00%)  0 0/35 (0.00%)  0
Sinusitis   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Tonsillitis   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Upper respiratory tract infection   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Varicella   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Viral infection   0/38 (0.00%)  0 1/37 (2.70%)  1 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Viral rash   0/38 (0.00%)  0 1/37 (2.70%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Viral upper respiratory tract infection   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Injury, poisoning and procedural complications           
Lower limb fracture   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders           
Febrile convulsion   1/38 (2.63%)  1 1/37 (2.70%)  1 1/38 (2.63%)  3 0/37 (0.00%)  0 0/35 (0.00%)  0
Reproductive system and breast disorders           
Balanoposthitis   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Vascular disorders           
Kawasaki’s disease   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
H5N1 Formulation 1 Group H5N1 Formulation 2 Group H5N1 Formulation 3 Group H5N1 Formulation 4 Group H5N1 Formulation 5 Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/38 (94.74%)      31/37 (83.78%)      35/38 (92.11%)      35/37 (94.59%)      32/35 (91.43%)    
Blood and lymphatic system disorders           
Anaemia   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Iron deficiency anaemia   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Eye disorders           
Erythema of eyelid   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Eyelid oedema   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Periorbital oedema   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Gastrointestinal disorders           
Abdominal discomfort   0/38 (0.00%)  0 1/37 (2.70%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Abdominal pain   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Constipation   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 2/35 (5.71%)  2
Diarrhoea   2/38 (5.26%)  2 2/37 (5.41%)  2 1/38 (2.63%)  1 2/37 (5.41%)  2 3/35 (8.57%)  3
Flatulence   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Food poisoning   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Gastritis   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Gastrointestinal inflammation   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Mouth ulceration   1/38 (2.63%)  1 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 1/35 (2.86%)  1
Vomiting   3/38 (7.89%)  3 0/37 (0.00%)  0 1/38 (2.63%)  1 2/37 (5.41%)  2 3/35 (8.57%)  3
General disorders           
Feeling hot   2/38 (5.26%)  4 0/37 (0.00%)  0 3/38 (7.89%)  3 1/37 (2.70%)  1 0/35 (0.00%)  0
Influenza like illness   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Injection site erythema   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Injection site urticaria   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Pain   20/38 (52.63%)  39 15/37 (40.54%)  32 16/38 (42.11%)  31 20/37 (54.05%)  31 17/35 (48.57%)  36
Pyrexia   24/38 (63.16%)  36 17/37 (45.95%)  21 15/38 (39.47%)  16 16/37 (43.24%)  20 12/35 (34.29%)  15
Swelling   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Infections and infestations           
Acute sinusitis   0/38 (0.00%)  0 0/37 (0.00%)  0 2/38 (5.26%)  2 0/37 (0.00%)  0 0/35 (0.00%)  0
Bronchiolitis   0/38 (0.00%)  0 1/37 (2.70%)  1 1/38 (2.63%)  1 2/37 (5.41%)  2 0/35 (0.00%)  0
Bronchitis   2/38 (5.26%)  2 2/37 (5.41%)  2 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Bronchitis viral   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Candida infection   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Cellulitis   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Conjunctivitis   0/38 (0.00%)  0 2/37 (5.41%)  3 2/38 (5.26%)  2 0/37 (0.00%)  0 0/35 (0.00%)  0
Enterovirus infection   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Gastroenteritis   1/38 (2.63%)  1 2/37 (5.41%)  3 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Gastroenteritis viral   2/38 (5.26%)  2 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Hand-foot-and-mouth disease   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Hordeolum   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Impetigo   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Influenza   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Nasopharyngitis   10/38 (26.32%)  13 8/37 (21.62%)  10 10/38 (26.32%)  15 5/37 (13.51%)  6 9/35 (25.71%)  10
Oral herpes   0/38 (0.00%)  0 1/37 (2.70%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Otitis media   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Otitis media acute   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Paronychia   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Pharyngitis   3/38 (7.89%)  6 1/37 (2.70%)  1 5/38 (13.16%)  5 1/37 (2.70%)  1 3/35 (8.57%)  3
Pharyngotonsillitis   0/38 (0.00%)  0 1/37 (2.70%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Pneumonia   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Respiratory syncytial virus bronchitis   1/38 (2.63%)  1 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Roseola   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Sinusitis   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  2 0/37 (0.00%)  0 0/35 (0.00%)  0
Tonsillitis   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Upper respiratory tract infection   7/38 (18.42%)  7 8/37 (21.62%)  10 6/38 (15.79%)  6 13/37 (35.14%)  16 8/35 (22.86%)  9
Viral diarrhoea   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Viral infection   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 1/35 (2.86%)  1
Viral rash   3/38 (7.89%)  3 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Viral upper respiratory tract infection   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Injury, poisoning and procedural complications           
Arthropod bite   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Contusion   0/38 (0.00%)  0 1/37 (2.70%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Forearm fracture   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Foreign body in eye   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Head injury   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Limb injury   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Skin abrasion   0/38 (0.00%)  0 1/37 (2.70%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Investigations           
Body height below normal   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Body temperature increased   1/38 (2.63%)  1 0/37 (0.00%)  0 2/38 (5.26%)  2 1/37 (2.70%)  1 1/35 (2.86%)  1
Cardiac murmur   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Metabolism and nutrition disorders           
Decreased appetite   25/38 (65.79%)  39 13/37 (35.14%)  16 14/38 (36.84%)  20 20/37 (54.05%)  30 13/35 (37.14%)  19
Failure to thrive   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders           
Febrile convulsion   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Headache   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Somnolence   25/38 (65.79%)  42 18/37 (48.65%)  29 13/38 (34.21%)  20 17/37 (45.95%)  29 16/35 (45.71%)  24
Speech disorder developmental   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Product Issues           
Device breakage   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Psychiatric disorders           
Irritability   24/38 (63.16%)  39 17/37 (45.95%)  26 19/38 (50.00%)  31 22/37 (59.46%)  35 21/35 (60.00%)  38
Respiratory, thoracic and mediastinal disorders           
Asthma   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Bronchial hyperreactivity   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Cough   0/38 (0.00%)  0 2/37 (5.41%)  2 2/38 (5.26%)  2 3/37 (8.11%)  3 1/35 (2.86%)  2
Increased upper airway secretion   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Oropharyngeal pain   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Productive cough   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Respiration abnormal   0/38 (0.00%)  0 1/37 (2.70%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Rhinitis allergic   0/38 (0.00%)  0 0/37 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0 1/35 (2.86%)  1
Rhinorrhoea   1/38 (2.63%)  1 2/37 (5.41%)  3 5/38 (13.16%)  7 1/37 (2.70%)  3 2/35 (5.71%)  2
Skin and subcutaneous tissue disorders           
Blister   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Dermatitis allergic   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Dermatitis atopic   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Dermatitis diaper   2/38 (5.26%)  2 1/37 (2.70%)  1 1/38 (2.63%)  1 0/37 (0.00%)  0 1/35 (2.86%)  1
Eczema   1/38 (2.63%)  1 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Erythema   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Rash   0/38 (0.00%)  0 0/37 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1 1/35 (2.86%)  1
Rash generalised   0/38 (0.00%)  0