Trial Outcomes & Findings for A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64 (NCT NCT00695669)

Results Overview

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer less than (\<) 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

312 participants

Primary outcome timeframe

At Day 14 post Dose 2

Results posted on

2018-07-31

Participant Flow

Participant milestones

Participant milestones
Measure	Influenza A (H5N1) 1 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Study STARTED	78	78	78	78
Overall Study COMPLETED	74	74	75	74
Overall Study NOT COMPLETED	4	4	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Influenza A (H5N1) 1 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Study Adverse Event	0	0	2	0
Overall Study Lost to Follow-up	4	4	1	4

Baseline Characteristics

A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Influenza A (H5N1) 1 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.	Total n=312 Participants Total of all reporting groups
Age, Continuous	40.2 Years STANDARD_DEVIATION 13.88 • n=5 Participants	39.7 Years STANDARD_DEVIATION 13.81 • n=7 Participants	40.8 Years STANDARD_DEVIATION 13.87 • n=5 Participants	40.7 Years STANDARD_DEVIATION 13.22 • n=4 Participants	40.3 Years STANDARD_DEVIATION 13.64 • n=21 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	36 Participants n=7 Participants	43 Participants n=5 Participants	48 Participants n=4 Participants	166 Participants n=21 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	42 Participants n=7 Participants	35 Participants n=5 Participants	30 Participants n=4 Participants	146 Participants n=21 Participants

PRIMARY outcome

Timeframe: At Day 14 post Dose 2

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer less than (\<) 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=65 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=69 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=74 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=75 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	63 Subjects	64 Subjects	53 Subjects	54 Subjects

PRIMARY outcome

Timeframe: At Day 0 and at Day 14 post Dose 2

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs). The Confidence Interval for this outcome was 98.75%.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=65 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=69 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=74 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=75 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 0	5.4 titers Interval 4.7 to 6.1	5.3 titers Interval 4.7 to 6.0	5.5 titers Interval 4.8 to 6.3	5.8 titers Interval 4.8 to 7.0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 14 post Dose 2	640.0 titers Interval 413.7 to 990.0	345.0 titers Interval 221.2 to 538.1	77.7 titers Interval 49.9 to 121.0	67.4 titers Interval 42.5 to 107.0

PRIMARY outcome

Timeframe: At Day 0 and at Day 14 post Dose 2

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=65 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=69 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=74 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=75 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 0	2 Subjects	1 Subjects	2 Subjects	3 Subjects
Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 14 post Dose 2	63 Subjects	64 Subjects	55 Subjects	56 Subjects

SECONDARY outcome

Timeframe: At Days 0, 21, 28, 35, 42 and 182.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=65 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 0 [N=65]	5.4 titers Interval 4.9 to 5.9	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 21 [N=64]	40.2 titers Interval 27.9 to 58.1	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 28 [N=65]	150.9 titers Interval 101.1 to 225.1	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 35 [N=65]	640.0 titers Interval 455.9 to 898.4	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 42 [N=62]	523.3 titers Interval 366.0 to 748.3	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 182 [N=65]	51.1 titers Interval 37.0 to 70.6	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 14, 21, 28, 35, 42 and 182.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=69 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 0 [N=69]	5.3 titers Interval 4.9 to 27.5	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 14 [N=68]	26.8 titers Interval 18.8 to 38.0	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 21 [N=69]	99.8 titers Interval 67.0 to 148.8	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 28 [N=69]	345.0 titers Interval 244.2 to 487.5	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 35 [N=69]	305.9 titers Interval 220.8 to 423.7	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 42 [N=68]	262.3 titers Interval 192.9 to 356.8	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 182 [N=68]	36.5 titers Interval 27.5 to 48.4	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 7, 14, 21, 28, 42 and 182.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=74 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 0 [N=74]	5.5 titers Interval 4.9 to 6.1	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 7 [N=74]	7.6 titers Interval 6.1 to 9.4	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 14 [N=73]	45.1 titers Interval 32.0 to 63.5	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 21 [N=74]	77.7 titers Interval 55.1 to 109.7	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 28 [N=72]	99.8 titers Interval 70.9 to 140.6	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 42 [N=73]	81.1 titers Interval 58.7 to 112.0	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 182 [N=71]	21.3 titers Interval 16.2 to 28.1	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 7, 14, 21, 42 and 182.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=75 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 0 [N=75]	5.8 titers Interval 5.0 to 6.7	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 7 [N=74]	10.8 titers Interval 8.0 to 14.6	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 14 [N=75]	67.4 titers Interval 47.1 to 96.6	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 21 [N=74]	76.3 titers Interval 52.6 to 110.8	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 42 [N=74]	78.9 titers Interval 55.8 to 111.5	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 182 [N=73]	28.2 titers Interval 21.0 to 37.8	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 21, 28, 35, 42 and 182.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=65 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 0 [N=65]	5.3 titers Interval 4.9 to 5.8	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 21 [N=64]	9.7 titers Interval 7.3 to 12.9	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 28 [N=65]	20.7 titers Interval 15.0 to 28.6	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 35 [N=65]	61.6 titers Interval 44.4 to 85.6	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 42 [N=62]	48.6 titers Interval 34.7 to 68.1	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 0 [N=65]	7.6 titers Interval 6.0 to 9.7	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 21 [N=64]	22.5 titers Interval 16.5 to 30.8	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 28 [N=65]	46.4 titers Interval 32.0 to 67.4	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 35 [N=65]	181.8 titers Interval 131.9 to 250.7	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 42 [N=62]	162.7 titers Interval 120.9 to 218.9	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at 182 [N=65]	25.8 titers Interval 19.1 to 35.0	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 14, 21, 28, 35, 42 and 182.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=69 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 0 [N=69]	5.4 titers Interval 5.0 to 5.9	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 14 [N=68]	9.2 titers Interval 7.2 to 11.7	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 21 [N=69]	15.1 titers Interval 11.2 to 20.3	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 28 [N=69]	29.9 titers Interval 21.8 to 40.9	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 35 [N=69]	26.5 titers Interval 19.9 to 35.2	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 42 [N=68]	23.2 titers Interval 17.4 to 30.9	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 0 [N=69]	7.1 titers Interval 5.7 to 8.9	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 14 [N=68]	17.0 titers Interval 12.0 to 24.0	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 21 [N=69]	36.4 titers Interval 25.4 to 52.1	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 28 [N=69]	83.7 titers Interval 59.2 to 118.4	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 35 [N=69]	74.9 titers Interval 54.7 to 102.5	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 42 [N=68]	68.3 titers Interval 50.5 to 92.4	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 182 [N=68]	18.5 titers Interval 14.1 to 24.4	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 7, 14, 21, 28, 42 and 182.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=74 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 0 [N=74]	5.3 titers Interval 4.9 to 5.8	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 7 [N=74]	6.4 titers Interval 5.6 to 7.4	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 14 [N=73]	13.7 titers Interval 10.4 to 17.9	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 21 [N=74]	16.1 titers Interval 12.2 to 21.2	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 28 [N=72]	15.3 titers Interval 11.6 to 20.1	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 42 [N=73]	13.4 titers Interval 10.5 to 17.1	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 0 [N=74]	7.2 titers Interval 5.9 to 8.9	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 7 [N=74]	8.7 titers Interval 6.8 to 11.2	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 14 [N=73]	27.2 titers Interval 19.9 to 37.3	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 21 [N=74]	33.5 titers Interval 23.9 to 46.7	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 28 [N=72]	34.9 titers Interval 25.2 to 48.4	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 42 [N=73]	34.7 titers Interval 24.9 to 48.4	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 182 [N=71]	13.7 titers Interval 10.6 to 17.7	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 7, 14, 21, 42 and 182.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=75 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 0 [N=75]	5.8 titers Interval 5.1 to 6.6	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 7 [N=74]	7.9 titers Interval 6.4 to 9.8	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 14 [N=75]	16.3 titers Interval 12.1 to 21.9	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 21 [N=74]	16.2 titers Interval 12.1 to 21.6	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 42 [N=74]	16.0 titers Interval 12.3 to 20.6	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 0 [N=75]	7.7 titers Interval 6.2 to 9.4	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 7 [N=74]	11.8 titers Interval 8.7 to 16.0	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 14 [N=75]	28.9 titers Interval 20.5 to 40.8	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 21 [N=74]	31.2 titers Interval 22.4 to 43.5	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 42 [N=74]	35.6 titers Interval 25.9 to 48.9	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 182 [N=73]	16.4 titers Interval 12.4 to 21.7	—	—	—

SECONDARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer \< 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=62 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=73 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=74 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. H5N1	59 Subjects	63 Subjects	57 Subjects	55 Subjects
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET	41 Subjects	35 Subjects	16 Subjects	19 Subjects
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK	52 Subjects	51 Subjects	41 Subjects	39 Subjects

SECONDARY outcome

Timeframe: At Day 182

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer \< 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=65 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=68 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=71 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=73 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. H5N1	45 Subjects	42 Subjects	29 Subjects	38 Subjects
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK	30 Subjects	22 Subjects	14 Subjects	18 Subjects

SECONDARY outcome

Timeframe: At Days 0, 42 and 182.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

The GMFR is presented as the GMT ratio between GMTs at Day 42/182 and at Day 0.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=65 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=68 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=73 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=74 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. H5N1 at Day 42 [N=62,68,73,74]	97.3 Fold increase Interval 67.1 to 141.2	49.4 Fold increase Interval 36.0 to 67.7	14.8 Fold increase Interval 10.6 to 20.5	13.5 Fold increase Interval 9.4 to 19.4
Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. H5N1 at Day 182 [N=65,68,71,73]	9.5 Fold increase Interval 6.9 to 13.2	6.9 Fold increase Interval 5.2 to 9.1	3.9 Fold increase Interval 2.9 to 5.1	4.8 Fold increase Interval 3.6 to 6.5
Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 42 [N=62,68,73,74]	9.1 Fold increase Interval 6.5 to 12.8	4.3 Fold increase Interval 3.2 to 5.7	2.5 Fold increase Interval 2.0 to 3.2	2.7 Fold increase Interval 2.2 to 3.5
Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 42 [N=62,68,73,74]	21.7 Fold increase Interval 15.1 to 31.3	9.6 Fold increase Interval 6.8 to 13.4	4.8 Fold increase Interval 3.4 to 6.6	4.6 Fold increase Interval 3.4 to 6.3
Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 182 [N=65,68,71,73]	3.4 Fold increase Interval 2.5 to 4.6	2.7 Fold increase Interval 2.0 to 3.7	1.9 Fold increase Interval 1.5 to 2.6	2.1 Fold increase Interval 1.6 to 2.8

SECONDARY outcome

Timeframe: At Days 0, 21, 28, 35, 42 and 182.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=65 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 0 [N=65]	31.8 titers Interval 24.3 to 41.4	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 21 [N=64]	85.0 titers Interval 65.0 to 111.1	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 28 [N=65]	99.8 titers Interval 78.2 to 127.3	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 35 [N=65]	142.6 titers Interval 113.7 to 178.8	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 42 [N=62]	151.3 titers Interval 120.3 to 190.3	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 0 [N=65]	26.5 titers Interval 20.1 to 35.1	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 21 [N=64]	57.5 titers Interval 43.7 to 75.6	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 28 [N=65]	139.9 titers Interval 102.5 to 191.1	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 35 [N=65]	442.6 titers Interval 343.6 to 570.3	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 42 [N=62]	377.0 titers Interval 296.1 to 480.0	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 182 [N=65]	245.5 titers Interval 186.2 to 323.5	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 14, 21, 28, 35, 42 and 182.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=69 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 0 [N=69]	34.5 titers Interval 27.7 to 42.8	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 14 [N=69]	99.4 titers Interval 80.6 to 122.5	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 21 [N=69]	104.3 titers Interval 85.4 to 127.4	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 28 [N=69]	146.9 titers Interval 119.6 to 180.4	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 35 [N=69]	142.0 titers Interval 119.1 to 169.4	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 42 [N=68]	134.5 titers Interval 109.0 to 166.0	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 0 [N=69]	24.1 titers Interval 20.0 to 29.1	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 14 [N=68]	64.9 titers Interval 49.6 to 84.9	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 21 [N=69]	107.0 titers Interval 82.0 to 139.7	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 28 [N=69]	224.0 titers Interval 183.4 to 273.4	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 35 [N=69]	221.7 titers Interval 181.9 to 270.3	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 42 [N=68]	227.8 titers Interval 187.0 to 277.6	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 182 [N=68]	230.2 titers Interval 184.2 to 287.6	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 7, 14, 21, 28, 42 and 182.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=74 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 0 [N=74]	32.9 titers Interval 26.0 to 41.6	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 7 [N=74]	42.2 titers Interval 33.5 to 53.1	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 14 [N=73]	125.5 titers Interval 96.4 to 163.3	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 21 [N=74]	133.8 titers Interval 103.1 to 173.8	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 28 [N=72]	119.4 titers Interval 93.6 to 152.3	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 42 [N=73]	114.5 titers Interval 91.2 to 143.7	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 0 [N=74]	23.4 titers Interval 18.7 to 29.4	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 7 [N=74]	25.1 titers Interval 20.3 to 31.1	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 14 [N=73]	83.6 titers Interval 61.6 to 113.5	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 21 [N=74]	105.8 titers Interval 80.0 to 140.0	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 28 [N=72]	115.5 titers Interval 87.0 to 153.4	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 42 [N=73]	146.7 titers Interval 118.3 to 182.0	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 182 [N=71]	138.7 titers Interval 105.9 to 181.8	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 7, 14, 21, 42 and 182.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=75 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 0 [N=75]	36.1 titers Interval 28.4 to 45.8	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 7 [N=74]	62.8 titers Interval 48.3 to 81.5	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 14 [N=75]	135.6 titers Interval 106.9 to 171.9	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 21 [N=74]	109.3 titers Interval 85.3 to 140.0	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at Day 42 [N=74]	93.7 titers Interval 72.3 to 121.4	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 0 [N=75]	24.3 titers Interval 19.6 to 30.1	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 7 [N=74]	36.5 titers Interval 27.8 to 47.8	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 14 [N=75]	97.2 titers Interval 74.2 to 127.3	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 21 [N=74]	97.5 titers Interval 75.3 to 126.4	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 42 [N=74]	132.1 titers Interval 103.1 to 169.3	—	—	—
Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at Day 182 [N=73]	147.3 titers Interval 112.9 to 192.3	—	—	—

SECONDARY outcome

Timeframe: At 7, 14 and 21 days after the second dose

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Subjects with a vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer \< 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=65 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=69 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=74 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=75 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at 7 days post dose 2 [N=65,69,73,74]	37 Subjects	37 Subjects	33 Subjects	11 Subjects
Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at 14 days post dose 2 [N=65,69,74,75]	54 Subjects	54 Subjects	43 Subjects	35 Subjects
Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK at 21 days post dose 2 [N=62,69,72,74]	50 Subjects	53 Subjects	40 Subjects	37 Subjects
Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at 21 days post dose 2 [N=62,69,71,74]	33 Subjects	32 Subjects	33 Subjects	33 Subjects
Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at 7 days post dose 2 [N=65,69,72,74]	28 Subjects	26 Subjects	34 Subjects	16 Subjects
Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET at 14 days post dose 2 [N=65,69,73,75]	35 Subjects	36 Subjects	33 Subjects	32 Subjects

SECONDARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Subjects with a vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer \< 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=62 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=68 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=73 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=74 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. VIET [N=62,68,72,74]	33 Subjects	34 Subjects	30 Subjects	24 Subjects
Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. TURK [N=62,68,73,74]	50 Subjects	55 Subjects	49 Subjects	44 Subjects

SECONDARY outcome

Timeframe: At Day 182

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Subjects with vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer \< 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=65 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=68 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=71 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=73 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Number of Subjects With a Vaccine Response of MN Assessed Antibodies for the Flu A/Turkey/Turkey/1/2005 (TURK) Strain of Influenza Disease.	47 Subjects	51 Subjects	45 Subjects	43 Subjects

SECONDARY outcome

Timeframe: Within the 7-day follow-up period (Days 0-6) after any vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available and had the symptom sheet completed.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=76 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=77 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=77 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Number of Subjects With Solicited Local Symptoms Any Pain	60 Subjects	64 Subjects	65 Subjects	65 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness	2 Subjects	5 Subjects	5 Subjects	4 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling	4 Subjects	5 Subjects	5 Subjects	3 Subjects

SECONDARY outcome

Timeframe: Within the 7-day follow-up period (Days 0-6) after any vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available and had the symptom sheet completed.

Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature ≥ 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=76 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=77 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=77 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Number of Subjects With Solicited General Symptoms Any Headache	30 Subjects	28 Subjects	24 Subjects	20 Subjects
Number of Subjects With Solicited General Symptoms Any Joint Pain	20 Subjects	23 Subjects	22 Subjects	11 Subjects
Number of Subjects With Solicited General Symptoms Any Muscle Aches	49 Subjects	43 Subjects	40 Subjects	40 Subjects
Number of Subjects With Solicited General Symptoms Any Shivering	10 Subjects	13 Subjects	13 Subjects	10 Subjects
Number of Subjects With Solicited General Symptoms Any Sweating	15 Subjects	11 Subjects	8 Subjects	5 Subjects
Number of Subjects With Solicited General Symptoms Any Fatigue	23 Subjects	30 Subjects	22 Subjects	27 Subjects
Number of Subjects With Solicited General Symptoms Any Fever	2 Subjects	4 Subjects	1 Subjects	1 Subjects

SECONDARY outcome

Timeframe: From Day 0 to 182

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.

A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Number of Subjects With Medically Attended Adverse Events (MAEs).	18 Subjects	19 Subjects	15 Subjects	21 Subjects

SECONDARY outcome

Timeframe: Within the 51-day follow-up period (Days 0-50) after first vaccination.

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.

An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Number of Subjects With Unsolicited Adverse Events (AEs)	34 Subjects	37 Subjects	41 Subjects	27 Subjects

SECONDARY outcome

Timeframe: From Day 0 to 182

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.

A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 1 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Number of Subjects With Any Serious Adverse Events (SAEs)	1 Subjects	0 Subjects	3 Subjects	1 Subjects

Adverse Events

Influenza A (H5N1) 1 Group

Serious events: 1 serious events

Other events: 66 other events

Deaths: 0 deaths

Influenza A (H5N1) 2 Group

Serious events: 0 serious events

Other events: 67 other events

Deaths: 0 deaths

Influenza A (H5N1) 3 Group

Serious events: 3 serious events

Other events: 68 other events

Deaths: 0 deaths

Influenza A (H5N1) 4 Group

Serious events: 1 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Influenza A (H5N1) 1 Group n=78 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 2 Group n=78 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 3 Group n=78 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Influenza A (H5N1) 4 Group n=78 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Cardiac disorders Cardiac failure congestive	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	1.3% 1/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Cellulitis	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	1.3% 1/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	1.3% 1/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Injury	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	1.3% 1/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Gastrointestinal disorders Irritable bowel syndrome	1.3% 1/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Cardiac disorders Myocardial infarction	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	1.3% 1/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Vascular disorders Phlebitis	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	1.3% 1/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Nervous system disorders Syncope	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	1.3% 1/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182. For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER