Trial Outcomes & Findings for Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults (NCT NCT00449670)

Last Updated: 2020-04-09

Results Overview

Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1206 participants

Primary outcome timeframe

Before vaccination (Day 0)

Results posted on

2020-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	H5N1 Adjuvanted Group Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Primary Phase (Study no.109630) STARTED	961	245
Primary Phase (Study no.109630) COMPLETED	947	243
Primary Phase (Study no.109630) NOT COMPLETED	14	2
Booster Phase (Study no.109873) STARTED	265	236
Booster Phase (Study no.109873) COMPLETED	265	233
Booster Phase (Study no.109873) NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	H5N1 Adjuvanted Group Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Primary Phase (Study no.109630) Serious Adverse Event	1	0
Primary Phase (Study no.109630) Non-serious adverse event	4	0
Primary Phase (Study no.109630) Withdrawal by Subject	4	1
Primary Phase (Study no.109630) Lost to Follow-up	5	1
Booster Phase (Study no.109873) Migrated/moved from study area	0	1
Booster Phase (Study no.109873) Other	0	2

Baseline Characteristics

Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	H5N1 Adjuvanted Group n=961 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group n=245 Participants Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	Total n=1206 Participants Total of all reporting groups
Age, Continuous	33.75 years STANDARD_DEVIATION 9.82 • n=93 Participants	32.95 years STANDARD_DEVIATION 9.18 • n=4 Participants	33.59 years STANDARD_DEVIATION 9.7 • n=27 Participants
Sex: Female, Male Female	495 Participants n=93 Participants	122 Participants n=4 Participants	617 Participants n=27 Participants
Sex: Female, Male Male	466 Participants n=93 Participants	123 Participants n=4 Participants	589 Participants n=27 Participants
Race/Ethnicity, Customized Race · Asian - Central/ South Asian Heritage	16 Participants n=93 Participants	6 Participants n=4 Participants	22 Participants n=27 Participants
Race/Ethnicity, Customized Race · Asian - East Asian Heritage	589 Participants n=93 Participants	145 Participants n=4 Participants	734 Participants n=27 Participants
Race/Ethnicity, Customized Race · Asian - South East Asian Heritage	355 Participants n=93 Participants	93 Participants n=4 Participants	448 Participants n=27 Participants
Race/Ethnicity, Customized Race · White - Arabic / North African Heritage	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Race · White - Caucasian / European Heritage	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: Before vaccination (Day 0)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=233 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=235 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 n=231 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 n=234 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group n=236 Participants Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004	5.6 Titers Interval 5.3 to 5.9	5.5 Titers Interval 5.2 to 5.8	5.6 Titers Interval 5.2 to 5.9	5.4 Titers Interval 5.2 to 5.7	5.6 Titers Interval 5.3 to 5.9	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005	5.1 Titers Interval 5.0 to 5.2	5 Titers Interval 5.0 to 5.1	5 Titers Interval 5.0 to 5.1	5.1 Titers Interval 5.0 to 5.1	5.0 Titers Interval 5.0 to 5.1	—

PRIMARY outcome

Timeframe: Within 21 days following 2-dose primary vaccination (at Day 42)

Population: Analysis was performed on subjects from H5N1 Adjuvanted Lot Groups, included in the ATP cohort for immunogenicity, for lot-to-lot consistency of the immune response elicited by four compositions of GSK Biological's pandemic influenza candidate vaccine. Analysis was also performed on the subjects from the H5N1 unadjuvanted group

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=229 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=233 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 n=229 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 n=233 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group n=234 Participants Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004	192.7 Titers Interval 164.2 to 226.2	235.2 Titers Interval 203.1 to 272.5	225.6 Titers Interval 193.5 to 263.0	226.3 Titers Interval 194.0 to 264.0	7.5 Titers Interval 6.7 to 8.3	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005	24.3 Titers Interval 20.4 to 29.0	27.9 Titers Interval 23.4 to 33.3	25.5 Titers Interval 21.2 to 30.7	22.4 Titers Interval 18.6 to 27.0	5.2 Titers Interval 5.0 to 5.4	—

SECONDARY outcome

Timeframe: Within 21 days following the first primary vaccination dose (Day 21)

Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=231 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=233 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 n=228 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 n=233 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group n=234 Participants Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004	21.8 Titers Interval 18.1 to 26.2	25.1 Titers Interval 20.7 to 30.5	24 Titers Interval 19.6 to 29.3	20.5 Titers Interval 17.0 to 24.6	6.7 Titers Interval 6.0 to 7.4	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005	6.3 Titers Interval 5.7 to 6.8	5.9 Titers Interval 5.6 to 6.3	5.9 Titers Interval 5.5 to 6.4	5.1 Titers Interval 5.0 to 5.1	5.2 Titers Interval 5.0 to 5.3	—

SECONDARY outcome

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)

Population: The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received a booster dose at Month 6 for whom immunogenicity data for the considered assay and timepoint were available.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=256 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=229 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6	19.1 Titers Interval 16.5 to 22.2	5.8 Titers Interval 5.4 to 6.2	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+21D	397.4 Titers Interval 342.5 to 461.0	30.1 Titers Interval 24.9 to 36.3	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+42D	—	76.3 Titers Interval 64.1 to 90.8	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6	6.4 Titers Interval 6.0 to 6.9	5.1 Titers Interval 5.0 to 5.1	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+21D	321.3 Titers Interval 274.3 to 376.2	24.8 Titers Interval 20.5 to 30.0	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+42D	—	96.3 Titers Interval 80.6 to 115.1	—	—	—	—

SECONDARY outcome

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D) and at Month 12 (M12)

Population: The analysis was performed on the Booster ATP cohort for persistence, which included all evaluable subjects who received a booster dose at Month 6, who complied with the protocol during the entire study period and for whom immunogenicity data for the considered assay and timepoint were available.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=251 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=224 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6	19.4 Titers Interval 16.6 to 22.5	5.8 Titers Interval 5.4 to 6.2	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+21D	395.3 Titers Interval 339.8 to 459.7	31.0 Titers Interval 25.6 to 37.5	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+42D	—	78 Titers Interval 65.5 to 92.9	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M12	76.1 Titers Interval 62.5 to 92.7	14.3 Titers Interval 12.2 to 16.8	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6	6.5 Titers Interval 6.0 to 6.9	5.1 Titers Interval 5.0 to 5.1	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+21D	319.1 Titers Interval 271.7 to 374.7	25.5 Titers Interval 21.0 to 30.9	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+42D	—	98.5 Titers Interval 82.3 to 117.9	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M12	46.9 Titers Interval 38.3 to 57.4	14.6 Titers Interval 12.5 to 17.1	—	—	—	—

SECONDARY outcome

Timeframe: Before vaccination at Day 0 (D0) and within 21 days following 2-dose primary vaccination at Day 42 (D42)

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=68 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=74 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 n=69 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 n=69 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group n=71 Participants Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Titers for Serum Neutralizing (SN) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, D0	17.8 Titers Interval 15.4 to 20.5	17.8 Titers Interval 15.7 to 20.2	18 Titers Interval 15.7 to 20.8	16.6 Titers Interval 15.3 to 18.1	17.7 Titers Interval 15.4 to 20.4	—
Titers for Serum Neutralizing (SN) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, D42	274.4 Titers Interval 232.7 to 323.5	330.6 Titers Interval 281.4 to 388.4	283.1 Titers Interval 234.2 to 342.3	350.4 Titers Interval 293.9 to 417.8	29.0 Titers Interval 23.4 to 35.9	—
Titers for Serum Neutralizing (SN) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, D0	14.6 Titers Interval 14.0 to 15.3	14.8 Titers Interval 14.0 to 15.7	15.3 Titers Interval 13.7 to 17.2	14.7 Titers Interval 13.9 to 15.5	15.6 Titers Interval 14.4 to 16.7	—
Titers for Serum Neutralizing (SN) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, D42	74.3 Titers Interval 61.9 to 89.3	100.0 Titers Interval 86.0 to 116.5	80.4 Titers Interval 66.7 to 96.9	82.1 Titers Interval 69.8 to 96.5	16.2 Titers Interval 14.8 to 17.8	—

SECONDARY outcome

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=184 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=47 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6	170.5 Titers Interval 154.6 to 188.0	29.4 Titers Interval 23.0 to 37.6	—	—	—	—
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+21D	1660.1 Titers Interval 1435.9 to 1919.4	248.1 Titers Interval 187.0 to 329.0	—	—	—	—
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+42D	—	447.1 Titers Interval 331.9 to 602.1	—	—	—	—
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6	183.6 Titers Interval 167.0 to 201.8	30.3 Titers Interval 22.8 to 40.1	—	—	—	—
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+21D	2917.5 Titers Interval 2490.8 to 3417.3	451.9 Titers Interval 357.5 to 571.3	—	—	—	—
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+42D	—	1075.8 Titers Interval 834.7 to 1386.6	—	—	—	—

SECONDARY outcome

Timeframe: At Day 0, at Day 21, at Day 42, at Month 6 and at Month 12

Population: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects who did not receive a booster dose at Month 6 (Non-Boosted sub-cohort), who complied with the protocol during the entire study period and for whom immunogenicity data for the considered assay and timepoint were available.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=665 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 A/Vietnam/1194/2004, D0	5.6 Titers Interval 5.4 to 5.7	—	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 A/Vietnam/1194/2004, D21	23.3 Titers Interval 20.8 to 26.1	—	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 A/Vietnam/1194/2004, D42	215.7 Titers Interval 197.4 to 235.7	—	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 A/Vietnam/1194/2004, M6	18.5 Titers Interval 17.0 to 20.3	—	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 A/Vietnam/1194/2004, M12	11.4 Titers Interval 10.4 to 12.5	—	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 A/Indonesia/5/2005, D0	5.1 Titers Interval 5.0 to 5.1	—	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 A/Indonesia/5/2005, D21	6.1 Titers Interval 5.8 to 6.3	—	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 A/Indonesia/5/2005, D42	24.8 Titers Interval 22.3 to 27.5	—	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 A/Indonesia/5/2005, M6	6.3 Titers Interval 6.0 to 6.5	—	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 A/Indonesia/5/2005, M12	6.2 Titers Interval 5.9 to 6.5	—	—	—	—	—

SECONDARY outcome

Timeframe: At Month 12

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=166 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 A/Vietnam/1194/2004	215.5 Titers Interval 191.4 to 242.7	—	—	—	—	—
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 A/Indonesia/5/2005	57.9 Titers Interval 50.5 to 66.4	—	—	—	—	—

SECONDARY outcome

Timeframe: At Day 21 (D21) and at Day 42 (D42)

Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=231 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=233 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 n=229 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 n=233 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group n=234 Participants Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, D21	97 Participants	103 Participants	97 Participants	96 Participants	8 Participants	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, D42	213 Participants	220 Participants	214 Participants	219 Participants	13 Participants	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, D21	9 Participants	4 Participants	5 Participants	6 Participants	0 Participants	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, D42	108 Participants	128 Participants	118 Participants	110 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=254 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=228 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+42D	0 Participants	174 Participants	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6	9 Participants	0 Participants	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+21D	241 Participants	105 Participants	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+42D	0 Participants	188 Participants	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6	96 Participants	2 Participants	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+21D	244 Participants	110 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Following booster vaccination at Month 6 +21 days (M6+21D) and Month 6 +42 days (M6+42D)

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=256 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=228 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase A/Vietnam/1194/2004, M6+21D	233 Participants	112 Participants	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase A/Vietnam/1194/2004, M6+42D	0 Participants	173 Participants	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase A/Indonesia/5/2005, M6+21D	241 Participants	106 Participants	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase A/Indonesia/5/2005, M6+42D	0 Participants	189 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At Month 12

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=228 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=209 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase A/Vietnam/1194/2004	93 Participants	57 Participants	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase A/Indonesia/5/2005	140 Participants	67 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Within 21 days following 2-dose primary vaccination at Day 42

Seroconversion was defined as: antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=68 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=73 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 n=69 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 n=69 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group n=71 Participants Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004	64 Participants	70 Participants	64 Participants	68 Participants	23 Participants	—
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005	61 Participants	70 Participants	61 Participants	63 Participants	4 Participants	—

SECONDARY outcome

Timeframe: Following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)

Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:56 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=184 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=47 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease - Booster Phase A/Vietnam/1194/2004, M6+21D	140 Participants	36 Participants	—	—	—	—
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease - Booster Phase A/Vietnam/1194/2004, M6+42D	0 Participants	41 Participants	—	—	—	—
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease - Booster Phase A/Indonesia/5/2005, M6+21D	165 Participants	41 Participants	—	—	—	—
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease - Booster Phase A/Indonesia/5/2005, M6+42D	0 Participants	45 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At Day 21, Day 42, Month 6 and Month 12 following primary vaccination

Seroconversion defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-booster antibody titer.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=663 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6 A/Indonesia/5/2005, D42	328 Participants	—	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6 A/Indonesia/5/2005, M6	11 Participants	—	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6 A/Indonesia/5/2005, M12	25 Participants	—	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6 A/Vietnam/1194/2004, D21	293 Participants	—	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6 A/Vietnam/1194/2004, D42	620 Participants	—	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6 A/Vietnam/1194/2004, M6	228 Participants	—	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6 A/Vietnam/1194/2004, M12	108 Participants	—	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6 A/Indonesia/5/2005, D21	18 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: At Month 12

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=23 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, M12	20 Participants	—	—	—	—	—
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Indonesia/5/2005, M12	15 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: At day 21 and Day 42

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=231 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=233 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 n=229 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 n=233 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group n=234 Participants Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, D21	3.9 Fold change Interval 3.3 to 4.6	4.6 Fold change Interval 3.8 to 5.6	4.3 Fold change Interval 3.5 to 5.2	3.8 Fold change Interval 3.2 to 4.5	1.2 Fold change Interval 1.1 to 1.3	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, D42	34.4 Fold change Interval 29.2 to 40.5	43.2 Fold change Interval 37.0 to 50.5	40.5 Fold change Interval 34.6 to 47.5	41.6 Fold change Interval 35.6 to 48.5	1.3 Fold change Interval 1.2 to 1.5	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, D21	1.2 Fold change Interval 1.1 to 1.3	1.2 Fold change Interval 1.1 to 1.3	1.2 Fold change Interval 1.1 to 1.3	1.2 Fold change Interval 1.1 to 1.3	1.0 Fold change Interval 1.0 to 1.0	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, D42	4.8 Fold change Interval 4.0 to 5.7	5.6 Fold change Interval 4.6 to 6.6	5.1 Fold change Interval 4.2 to 6.1	4.4 Fold change Interval 3.7 to 5.3	1.0 Fold change Interval 1.0 to 1.1	—

SECONDARY outcome

Timeframe: Before booster vaccination at Month 6 (M6) and within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D)

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=254 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=228 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6	3.6 Fold change Interval 3.1 to 4.1	1 Fold change Interval 1.0 to 1.1	—	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+21D	74 Fold change Interval 63.1 to 86.7	5.3 Fold change Interval 4.4 to 6.4	—	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+42D	—	13.4 Fold change Interval 11.2 to 16.0	—	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6	1.3 Fold change Interval 1.2 to 1.4	1 Fold change Interval 1.0 to 1.0	—	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+21D	63.8 Fold change Interval 54.4 to 74.9	4.9 Fold change Interval 4.0 to 5.9	—	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+42D	—	18.9 Fold change Interval 15.8 to 22.6	—	—	—	—

SECONDARY outcome

Timeframe: Within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D)

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=256 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=228 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+21D	20.8 Fold change Interval 17.3 to 24.9	5.2 Fold change Interval 4.3 to 6.2	—	—	—	—
Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+42D	—	13.2 Fold change Interval 11.1 to 15.8	—	—	—	—
Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+21D	50 Fold change Interval 42.5 to 58.8	4.9 Fold change Interval 4.1 to 5.9	—	—	—	—
Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+42D	—	19 Fold change Interval 15.9 to 22.7	—	—	—	—

SECONDARY outcome

Timeframe: At Month 12

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=228 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=209 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1194/2004	3.7 Fold change Interval 3.1 to 4.5	2.5 Fold change Interval 2.1 to 2.9	—	—	—	—
Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonesia/5/2005	7.2 Fold change Interval 5.9 to 8.8	2.9 Fold change Interval 2.5 to 3.4	—	—	—	—

SECONDARY outcome

Timeframe: At Day 21, at Day 42, at Month 6 and at Month 12

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=663 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, D21	4.2 Fold change Interval 3.8 to 4.7	—	—	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, D42	38.8 Fold change Interval 35.4 to 42.5	—	—	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, M6	3.3 Fold change Interval 3.1 to 3.6	—	—	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, M12	2 Fold change Interval 1.9 to 2.2	—	—	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Indonesia/5/2005, D21	1.2 Fold change Interval 1.2 to 1.3	—	—	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Indonesia/5/2005, D42	4.9 Fold change Interval 4.4 to 5.4	—	—	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Indonesia/5/2005, M6	1.2 Fold change Interval 1.2 to 1.3	—	—	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Indonesia/5/2005, M12	1.2 Fold change Interval 1.2 to 1.3	—	—	—	—	—

SECONDARY outcome

Timeframe: Before primary vaccination at Day 0 and within 21 days following each primary vaccination dose at Day 21 and at Day 42.

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=233 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=235 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 n=231 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 n=234 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group n=236 Participants Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, PRE	4 Participants	3 Participants	5 Participants	3 Participants	5 Participants	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, D21	102 Participants	108 Participants	102 Participants	100 Participants	16 Participants	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, D42	213 Participants	223 Participants	215 Participants	220 Participants	24 Participants	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease A/Indonesia/5/2005, PRE	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease A/Indonesia/5/2005, D21	10 Participants	4 Participants	6 Participants	7 Participants	0 Participants	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease A/Indonesia/5/2005, D42	108 Participants	128 Participants	118 Participants	110 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=256 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=229 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6	103 Participants	4 Participants	—	—	—	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+21D	247 Participants	121 Participants	—	—	—	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+42D	0 Participants	180 Participants	—	—	—	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6	9 Participants	0 Participants	—	—	—	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease RA/Indonesia/5/2005, M6+21D	243 Participants	106 Participants	—	—	—	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+42D	0 Participants	189 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=251 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=224 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6	103 Participants	4 Participants	—	—	—	—
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+21D	242 Participants	120 Participants	—	—	—	—
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M6+42D	0 Participants	177 Participants	—	—	—	—
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, M12	178 Participants	65 Participants	—	—	—	—
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6	9 Participants	0 Participants	—	—	—	—
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+21D	238 Participants	105 Participants	—	—	—	—
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M6+42D	0 Participants	186 Participants	—	—	—	—
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Indonesia/5/2005, M12	151 Participants	67 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At Day 0, Day 21, Day 42, Month 6 and Month 12

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=665 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, PRE	11 Participants	—	—	—	—	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, D21	307 Participants	—	—	—	—	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, D42	623 Participants	—	—	—	—	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, M6	247 Participants	—	—	—	—	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, M12	131 Participants	—	—	—	—	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Indonesia/5/2005, PRE	1 Participants	—	—	—	—	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Indonesia/5/2005, D21	21 Participants	—	—	—	—	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Indonesia/5/2005, D42	328 Participants	—	—	—	—	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Indonesia/5/2005, M6	13 Participants	—	—	—	—	—
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 A/Indonesia/5/2005, M12	26 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 21 days of each primary vaccine dose: at Day 21 and at Day 42

The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=6 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=7 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 n=6 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 n=4 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group n=4 Participants Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 n=5 Participants Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. 2 cytokines, D21	2602.17 T-cells per million T-cells Standard Deviation 1369.03	5627.00 T-cells per million T-cells Standard Deviation 3064.90	3632.00 T-cells per million T-cells Standard Deviation 1884.23	4060.75 T-cells per million T-cells Standard Deviation 1566.75	1037.5 T-cells per million T-cells Standard Deviation 290.62	1440.5 T-cells per million T-cells Standard Deviation 593.01
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. 2 cytokines, D42	4578.2 T-cells per million T-cells Standard Deviation 848.69	5425.57 T-cells per million T-cells Standard Deviation 2176.77	4917.67 T-cells per million T-cells Standard Deviation 1787.62	3862.00 T-cells per million T-cells Standard Deviation 1024.44	1024.5 T-cells per million T-cells Standard Deviation 547.92	1492.6 T-cells per million T-cells Standard Deviation 442.25
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. CD40L+1 cytokine, D21	2516.33 T-cells per million T-cells Standard Deviation 1390.64	5460.33 T-cells per million T-cells Standard Deviation 3093.55	3606.00 T-cells per million T-cells Standard Deviation 1871.46	3828.00 T-cells per million T-cells Standard Deviation 1332.47	893 T-cells per million T-cells Standard Deviation 298.4	1429.75 T-cells per million T-cells Standard Deviation 603.52
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. CD40L+1 cytokine, D42	4367.00 T-cells per million T-cells Standard Deviation 858.47	5307.29 T-cells per million T-cells Standard Deviation 2255.72	4863.50 T-cells per million T-cells Standard Deviation 1767.69	3769.75 T-cells per million T-cells Standard Deviation 980.19	1046.75 T-cells per million T-cells Standard Deviation 550.36	1496.4 T-cells per million T-cells Standard Deviation 416.88
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IL-2+1 cytokine, D21	2405.50 T-cells per million T-cells Standard Deviation 1357.76	5345.00 T-cells per million T-cells Standard Deviation 2828.98	3385.17 T-cells per million T-cells Standard Deviation 1752.85	3708.75 T-cells per million T-cells Standard Deviation 1542.48	925 T-cells per million T-cells Standard Deviation 272.94	1412.5 T-cells per million T-cells Standard Deviation 631.94
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IL-2+1 cytokine, D42	3981.40 T-cells per million T-cells Standard Deviation 611.95	5008.14 T-cells per million T-cells Standard Deviation 1938.05	4447.17 T-cells per million T-cells Standard Deviation 1591.81	3461.25 T-cells per million T-cells Standard Deviation 973.71	864 T-cells per million T-cells Standard Deviation 428.27	1422.4 T-cells per million T-cells Standard Deviation 432.38
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, D21	1459.00 T-cells per million T-cells Standard Deviation 947.19	2799.00 T-cells per million T-cells Standard Deviation 2049.50	1636.33 T-cells per million T-cells Standard Deviation 822.50	1741.50 T-cells per million T-cells Standard Deviation 817.26	667.5 T-cells per million T-cells Standard Deviation 144.96	951 T-cells per million T-cells Standard Deviation 439.73
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, D42	2570.60 T-cells per million T-cells Standard Deviation 874.72	2573.71 T-cells per million T-cells Standard Deviation 1258.22	2313.17 T-cells per million T-cells Standard Deviation 956.59	1706.00 T-cells per million T-cells Standard Deviation 298.05	667.5 T-cells per million T-cells Standard Deviation 477.67	913.2 T-cells per million T-cells Standard Deviation 262.45
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.TNF-α+1 cytokine, D21	1835.33 T-cells per million T-cells Standard Deviation 1124.45	3822.67 T-cells per million T-cells Standard Deviation 3294.28	2683.00 T-cells per million T-cells Standard Deviation 1560.15	1995.50 T-cells per million T-cells Standard Deviation 736.97	447.5 T-cells per million T-cells Standard Deviation 258.09	890.75 T-cells per million T-cells Standard Deviation 169.87
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.TNF-α+1 cytokine, D42	2813.40 T-cells per million T-cells Standard Deviation 1327.05	4047.71 T-cells per million T-cells Standard Deviation 2556.46	3670.00 T-cells per million T-cells Standard Deviation 1922.75	2493.25 T-cells per million T-cells Standard Deviation 1000.61	603 T-cells per million T-cells Standard Deviation 590.71	733.8 T-cells per million T-cells Standard Deviation 378.22

SECONDARY outcome

Timeframe: Within 21 days of each primary vaccine dose: at Day 21 and at Day 42

The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=6 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=7 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 n=6 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 n=4 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group n=4 Participants Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 n=5 Participants Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004,min. 2 cytokines, D21	166.0 T-cells per million cells Standard Deviation 182.34	236.33 T-cells per million cells Standard Deviation 177.38	76.67 T-cells per million cells Standard Deviation 116	127 T-cells per million cells Standard Deviation 122.34	289.5 T-cells per million cells Standard Deviation 225.57	785.5 T-cells per million cells Standard Deviation 1531.24
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. 2 cytokines, D42	161 T-cells per million cells Standard Deviation 128.26	176.43 T-cells per million cells Standard Deviation 204.71	69.17 T-cells per million cells Standard Deviation 67.19	32.5 T-cells per million cells Standard Deviation 32.3	147 T-cells per million cells Standard Deviation 125.63	172 T-cells per million cells Standard Deviation 305.46
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. CD40L+1 cytokine, D21	25.33 T-cells per million cells Standard Deviation 30.73	1.00 T-cells per million cells Standard Deviation 0	18.50 T-cells per million cells Standard Deviation 20.74	1 T-cells per million cells Standard Deviation 0	1 T-cells per million cells Standard Deviation 0	78 T-cells per million cells Standard Deviation 136.59
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. CD40L+1 cytokine, D42	15.20 T-cells per million cells Standard Deviation 31.75	12.71 T-cells per million cells Standard Deviation 30.99	13.50 T-cells per million cells Standard Deviation 19.49	10.25 T-cells per million cells Standard Deviation 11.06	1 T-cells per million cells Standard Deviation 0	47.8 T-cells per million cells Standard Deviation 33.69
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IL-2+1 cytokine, D21	144.33 T-cells per million cells Standard Deviation 165.58	131.67 T-cells per million cells Standard Deviation 70.81	66.17 T-cells per million cells Standard Deviation 104.61	120.75 T-cells per million cells Standard Deviation 153.51	198 T-cells per million cells Standard Deviation 278.6	341.5 T-cells per million cells Standard Deviation 663.12
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IL-2+1 cytokine, D42	140.00 T-cells per million cells Standard Deviation 148.92	108.71 T-cells per million cells Standard Deviation 114.78	80.83 T-cells per million cells Standard Deviation 73.51	30.00 T-cells per million cells Standard Deviation 22.77	139 T-cells per million cells Standard Deviation 103.58	138.6 T-cells per million cells Standard Deviation 205.65
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, D21	163.50 T-cells per million cells Standard Deviation 187.70	245.33 T-cells per million cells Standard Deviation 170.81	59.83 T-cells per million cells Standard Deviation 89.57	104.75 T-cells per million cells Standard Deviation 136.03	335 T-cells per million cells Standard Deviation 229.1	765.25 T-cells per million cells Standard Deviation 1510.55
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, D42	166.60 T-cells per million cells Standard Deviation 131.04	161.29 T-cells per million cells Standard Deviation 201.37	34.50 T-cells per million cells Standard Deviation 43.63	23.75 T-cells per million cells Standard Deviation 26.30	128.75 T-cells per million cells Standard Deviation 138.81	159.8 T-cells per million cells Standard Deviation 319.18
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.TNF-α+1 cytokine, D21	75.83 T-cells per million cells Standard Deviation 135.65	175.33 T-cells per million cells Standard Deviation 195.41	45.83 T-cells per million cells Standard Deviation 74.25	95.25 T-cells per million cells Standard Deviation 32.26	208.5 T-cells per million cells Standard Deviation 12.02	804 T-cells per million cells Standard Deviation 1485.55
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.TNF-α+1 cytokine, D42	89.20 T-cells per million cells Standard Deviation 64.10	164.14 T-cells per million cells Standard Deviation 194.30	72.50 T-cells per million cells Standard Deviation 100.04	29.75 T-cells per million cells Standard Deviation 34.98	79.5 T-cells per million cells Standard Deviation 127.03	110 T-cells per million cells Standard Deviation 227.33

SECONDARY outcome

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)

The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=7 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=8 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6+21D	6526.40 T-cells per million T-cells Standard Deviation 3484.66	3674.00 T-cells per million T-cells Standard Deviation 1062.72	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6+42D	—	4177.25 T-cells per million T-cells Standard Deviation 2092.28	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IL-2+1 cytokine, M12	3043.86 T-cells per million T-cells Standard Deviation 1386.80	2098.86 T-cells per million T-cells Standard Deviation 558.63	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6	1443.00 T-cells per million T-cells Standard Deviation 554.28	538.33 T-cells per million T-cells Standard Deviation 224.38	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6+21D	5544.20 T-cells per million T-cells Standard Deviation 3219.20	2671.00 T-cells per million T-cells Standard Deviation 863.72	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6+42D	—	3296.25 T-cells per million T-cells Standard Deviation 2060.05	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M12	2501.43 T-cells per million T-cells Standard Deviation 1190.18	1649.14 T-cells per million T-cells Standard Deviation 504.41	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. 2 cytokines, M6+21D	7049.60 T-cells per million T-cells Standard Deviation 3832.18	3898.00 T-cells per million T-cells Standard Deviation 1133.03	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. 2 cytokines, M6+42D	—	4472.75 T-cells per million T-cells Standard Deviation 2352.87	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. 2 cytokines, M12	3197.29 T-cells per million T-cells Standard Deviation 1428.81	2141.57 T-cells per million T-cells Standard Deviation 617.49	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6	1720.00 T-cells per million T-cells Standard Deviation 765.05	666 T-cells per million T-cells Standard Deviation 187.51	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6+21D	6849.60 T-cells per million T-cells Standard Deviation 3814.40	3885.60 T-cells per million T-cells Standard Deviation 1116.51	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6+42D	—	4330.88 T-cells per million T-cells Standard Deviation 2255.37	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. CD40L+1 cytokine, M12	3164.43 T-cells per million T-cells Standard Deviation 1419.03	2148.57 T-cells per million T-cells Standard Deviation 617.94	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6	921.00 T-cells per million T-cells Standard Deviation 489.49	409.00 T-cells per million T-cells Standard Deviation 227.75	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6+21D	3585.40 T-cells per million T-cells Standard Deviation 2106.34	1665.60 T-cells per million T-cells Standard Deviation 659.04	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6+42D	—	2332.25 T-cells per million T-cells Standard Deviation 1640.24	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M12	1592.57 T-cells per million T-cells Standard Deviation 781.64	1016.86 T-cells per million T-cells Standard Deviation 509.21	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6	1653.33 T-cells per million T-cells Standard Deviation 608.11	688.33 T-cells per million T-cells Standard Deviation 212.18	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. 2 cytokines, M6	1773.0 T-cells per million T-cells Standard Deviation 748.95	681.00 T-cells per million T-cells Standard Deviation 243.30	—	—	—	—

SECONDARY outcome

Timeframe: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)

The analyzed cytokines were CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=7 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=8 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. 2 cytokines, M6	55.00 T-cells per million T-cells Standard Deviation 49.76	306.00 T-cells per million T-cells Standard Deviation 363.19	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. 2 cytokines, M6+21D	50.00 T-cells per million T-cells Standard Deviation 47.94	62.60 T-cells per million T-cells Standard Deviation 47.45	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. 2 cytokines, M6+42D	—	257.63 T-cells per million T-cells Standard Deviation 484.86	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. 2 cytokines, M12	50.86 T-cells per million T-cells Standard Deviation 75.46	232.00 T-cells per million T-cells Standard Deviation 383.34	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6	3.67 T-cells per million T-cells Standard Deviation 4.62	5.33 T-cells per million T-cells Standard Deviation 7.51	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6+21D	23.80 T-cells per million T-cells Standard Deviation 24.65	31.20 T-cells per million T-cells Standard Deviation 52.39	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6+42D	—	5.38 T-cells per million T-cells Standard Deviation 10.85	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min. CD40L+1 cytokine, M12	12.29 T-cells per million T-cells Standard Deviation 12.11	4.71 T-cells per million T-cells Standard Deviation 9.83	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6	44 T-cells per million T-cells Standard Deviation 37.24	331.33 T-cells per million T-cells Standard Deviation 407.67	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6+21D	36 T-cells per million T-cells Standard Deviation 30.74	50.60 T-cells per million T-cells Standard Deviation 40.5	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6+42D	—	257 T-cells per million T-cells Standard Deviation 485.24	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M12	53 T-cells per million T-cells Standard Deviation 83.7	211.71 T-cells per million T-cells Standard Deviation 375.25	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6	22.67 T-cells per million T-cells Standard Deviation 33.29	162.00 T-cells per million T-cells Standard Deviation 229.00	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6+21D	39.40 T-cells per million T-cells Standard Deviation 38.00	36.60 T-cells per million T-cells Standard Deviation 33.08	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6+42D	—	147.88 T-cells per million T-cells Standard Deviation 246.47	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.IL-2+1 cytokine, M12	38.00 T-cells per million T-cells Standard Deviation 52.50	133.14 T-cells per million T-cells Standard Deviation 168.94	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6	58.67 T-cells per million T-cells Standard Deviation 58.52	290 T-cells per million T-cells Standard Deviation 335.72	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6+21D	24.6 T-cells per million T-cells Standard Deviation 23.56	219.88 T-cells per million T-cells Standard Deviation 443.7	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6+42D	—	219.88 T-cells per million T-cells Standard Deviation 443.7	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M12	34 T-cells per million T-cells Standard Deviation 63.9	204.43 T-cells per million T-cells Standard Deviation 376.77	—	—	—	—

SECONDARY outcome

Timeframe: At Month 6 and Month 12

The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=30 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min. 2 cytokines, M6	2529.54 T-cells per million T-cells Standard Deviation 1063.65	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min. 2 cytokines, M12	2098.17 T-cells per million T-cells Standard Deviation 1287.49	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6	2407.31 T-cells per million T-cells Standard Deviation 1009.26	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min. CD40L+1 cytokine, M12	2004.27 T-cells per million T-cells Standard Deviation 1193.53	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6	1387.38 T-cells per million T-cells Standard Deviation 840.81	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M12	1184.07 T-cells per million T-cells Standard Deviation 992.44	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6	2341.15 T-cells per million T-cells Standard Deviation 936.20	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min.IL-2+1 cytokine, M12	1912.60 T-cells per million T-cells Standard Deviation 1130.58	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6	1960.62 T-cells per million T-cells Standard Deviation 891.12	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M12	1599.20 T-cells per million T-cells Standard Deviation 945.88	—	—	—	—	—

SECONDARY outcome

Timeframe: At Month 6 and at Month 12

The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=30 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min. 2 cytokines, M6	82.69 T-cells per million T-cells Standard Deviation 166.59	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min. 2 cytokines, M12	106.13 T-cells per million T-cells Standard Deviation 173.19	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min. CD40L+1 cytokine, M6	9.62 T-cells per million T-cells Standard Deviation 13.90	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M6	67.23 T-cells per million T-cells Standard Deviation 145.99	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min.IFN-γ+1 cytokine, M12	102.93 T-cells per million T-cells Standard Deviation 161.31	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min.IL-2+1 cytokine, M6	66.00 T-cells per million T-cells Standard Deviation 117.35	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min.IL-2+1 cytokine, M12	70.90 T-cells per million T-cells Standard Deviation 128.03	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M6	59.08 T-cells per million T-cells Standard Deviation 111.73	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min.TNF-α+1 cytokine, M12	89.30 T-cells per million T-cells Standard Deviation 140.96	—	—	—	—	—
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 A/Vietnam/1194/2004, min. CD40L+1 cytokine, M12	4.53 T-cells per million T-cells Standard Deviation 8.18	—	—	—	—	—

SECONDARY outcome

Timeframe: During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall

Population: The analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects who had completed their symptom sheet for the considered timepoint.

Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=954 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=245 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	84 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	1 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Ecchymosis, Dose 1	8 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Ecchymosis, Dose 1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Induration, Dose 1	54 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Induration, Dose 1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	779 Participants	44 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	31 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	36 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Ecchymosis, Dose 2	3 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Ecchymosis, Dose 2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Induration, Dose 2	38 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Induration, Dose 2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	674 Participants	38 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	21 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	33 Participants	1 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	1 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	70 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Ecchymosis, Across doses	10 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Ecchymosis, Across doses	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Induration, Across doses	76 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Induration, Across doses	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	830 Participants	62 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	49 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	64 Participants	1 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	1 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	114 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	1 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall

Population: The analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects who had completed their symptom sheet for the considered timepoint.

Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=954 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=245 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	20 Participants	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	238 Participants	35 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	13 Participants	0 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	215 Participants	29 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 1	478 Participants	48 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 1	14 Participants	0 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 1	462 Participants	43 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	44 Participants	3 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	2 Participants	0 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	42 Participants	2 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 1	86 Participants	19 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 1	78 Participants	17 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia, Dose 2	147 Participants	14 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia, Dose 2	4 Participants	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia, Dose 2	147 Participants	13 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue , Dose 2	435 Participants	53 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue , Dose 2	26 Participants	2 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue , Dose 2	432 Participants	52 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	27 Participants	3 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	3 Participants	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	27 Participants	3 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	269 Participants	29 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	16 Participants	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	265 Participants	27 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 2	429 Participants	34 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 2	17 Participants	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 2	427 Participants	34 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	75 Participants	4 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	4 Participants	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	74 Participants	4 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 2	90 Participants	13 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 2	4 Participants	2 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 2	87 Participants	13 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia, Across doses	212 Participants	24 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia, Across doses	8 Participants	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia, Across doses	206 Participants	22 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue , Across doses	559 Participants	91 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue , Across doses	38 Participants	2 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue , Across doses	550 Participants	88 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Across doses	45 Participants	4 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Across doses	8 Participants	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Across doses	44 Participants	4 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	380 Participants	52 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	26 Participants	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	367 Participants	47 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Across doses	610 Participants	65 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Across doses	29 Participants	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Across doses	599 Participants	61 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	105 Participants	7 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	6 Participants	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	103 Participants	6 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Across doses	143 Participants	25 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Across doses	4 Participants	2 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Across doses	135 Participants	24 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia, Dose 1	118 Participants	16 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia, Dose 1	5 Participants	0 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia, Dose 1	109 Participants	14 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue , Dose 1	411 Participants	69 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue , Dose 1	18 Participants	0 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue , Dose 1	395 Participants	65 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	21 Participants	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	5 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the 7-days (Days 0-6) post-booster vaccination period

Population: The analysis was performed on the Booster Total Vaccinated Cohort, including all vaccinated subjects who were boosted at Month 6 and who had completed their symptom sheet for the considered timepoint. Considering subjects from H5N1 Adjuvanted Group only received one single booster dose, data are reported only for booster dose 1 for this group.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=265 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=235 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Ecchymosis, Booster dose 1	2 Participants	1 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Ecchymosis, Booster dose 1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Induration, Booster dose 1	21 Participants	14 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Induration, Booster dose 1	0 Participants	1 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Pain, Booster dose 1	214 Participants	187 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Pain, Booster dose 1	14 Participants	11 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Redness, Booster dose 1	16 Participants	7 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Redness, Booster dose 1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Swelling, Booster dose 1	36 Participants	24 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Swelling, Booster dose 1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Ecchymosis, Booster dose 2	0 Participants	2 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Ecchymosis, Booster dose 2	—	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Induration, Booster dose 2	—	14 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Induration, Booster dose 2	—	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Pain, Booster dose 2	—	159 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Pain, Booster dose 2	—	8 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Redness, Booster dose 2	—	15 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Redness, Booster dose 2	—	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Swelling, Booster dose 2	—	22 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Swelling, Booster dose 2	—	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Ecchymosis, Across booster doses	—	2 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Ecchymosis, Across booster doses	—	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Induration, Across booster doses	—	21 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Induration, Across booster doses	—	1 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Pain, Across booster doses	—	198 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Pain, Across booster doses	—	17 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Redness, Across booster doses	—	16 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Redness, Across booster doses	—	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Any Swelling, Across booster doses	—	33 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase Grade 3 Swelling, Across booster doses	—	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the 7-days (Days 0-6) post-booster vaccination period

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=265 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=235 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Arthralgia, Booster dose 1	57 Participants	33 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Arthralgia, Booster dose 1	4 Participants	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Arthralgia, Booster dose 1	57 Participants	32 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Fatigue , Booster dose 1	165 Participants	96 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Fatigue , Booster dose 1	15 Participants	3 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Fatigue , Booster dose 1	164 Participants	95 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Fever, Booster dose 1	16 Participants	7 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Fever, Booster dose 1	3 Participants	0 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Fever, Booster dose 1	16 Participants	7 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Headache, Booster dose 1	120 Participants	66 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Headache, Booster dose 1	8 Participants	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Headache, Booster dose 1	117 Participants	65 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Myalgia, Booster dose 1	169 Participants	126 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Myalgia, Booster dose 1	15 Participants	4 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Myalgia, Booster dose 1	168 Participants	126 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Shivering, Booster dose 1	47 Participants	18 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Shivering, Booster dose 1	5 Participants	0 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Shivering, Booster dose 1	47 Participants	18 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Sweating, Booster dose 1	25 Participants	15 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Sweating, Booster dose 1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Sweating, Booster dose 1	23 Participants	15 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Arthralgia, Booster dose 2	—	38 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Arthralgia, Booster dose 2	—	3 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Arthralgia, Booster dose 2	—	37 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Fatigue , Booster dose 2	—	95 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Fatigue , Booster dose 2	—	4 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Fatigue , Booster dose 2	—	94 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Fever, Booster dose 2	—	9 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Fever, Booster dose 2	—	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Fever, Booster dose 2	—	9 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Headache, Booster dose 2	—	69 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Headache, Booster dose 2	—	3 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Headache, Booster dose 2	—	68 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Myalgia, Booster dose 2	—	101 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Myalgia, Booster dose 2	—	5 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Myalgia, Booster dose 2	—	100 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Shivering, Booster dose 2	—	30 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Shivering, Booster dose 2	—	2 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Shivering, Booster dose 2	—	29 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Sweating, Booster dose 2	—	21 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Sweating, Booster dose 2	—	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Sweating, Booster dose 2	—	21 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Arthralgia, Across booster doses	—	54 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Arthralgia, Across booster doses	—	4 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Arthralgia, Across booster doses	—	52 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Fatigue , Across booster doses	—	121 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Fatigue , Across booster doses	—	6 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Fatigue , Across booster doses	—	119 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Fever, Across booster doses	—	14 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Fever, Across booster doses	—	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Fever, Across booster doses	—	14 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Headache, Across booster doses	—	97 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Headache, Across booster doses	—	3 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Headache, Across booster doses	—	96 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Myalgia, Across booster doses	—	141 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Myalgia, Across booster doses	—	9 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Myalgia, Across booster doses	—	141 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Shivering, Across booster doses	—	38 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Shivering, Across booster doses	—	2 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Shivering, Across booster doses	—	37 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Any Sweating, Across booster doses	—	28 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Grade 3 Sweating, Across booster doses	—	1 Participants	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase Related Sweating, Across booster doses	—	28 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the primary phase (from Day 0 to Month 6)

Population: The analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available for the considered timepoint.

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

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=961 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=245 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	308 Participants	75 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the booster phase (from Month 6 to Month 12)

Population: The analysis was performed on the Booster Total Vaccinated Cohort, including all vaccinated subjects who were boosted at Month 6 and for whom data were available for the considered timepoint.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=265 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=236 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	65 Participants	54 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the primary phase (from Day 0 to Month 6)

Population: The analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom were available for the considered timepoint.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=961 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=245 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Subjects With Serious Adverse Events (SAEs).	7 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the booster phase (from Month 6 to Month 12)

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=265 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 n=236 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Subjects With Serious Adverse Events (SAEs).	3 Participants	5 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From Month 6 to Month 12

Population: The analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects who were not boosted at Month 6 (Non-Boosted sub-cohort) and for whom data were available for the considered timepoint.

This group consists of the remaining subjects from the GSK1562902A Pooled Group who received a single dose of H5N1 vaccine at Month 12 or 36.

Outcome measures

Outcome measures
Measure	H5N1 Adjuvanted Group - Lot 1 n=672 Participants Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 2 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 3 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Adjuvanted Group - Lot 4 Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.	H5N1 Un-Adjuvanted Group - Lot 2 Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
Number of Subjects With Serious Adverse Events (SAEs) for Subjects Not Boosted at Month 6	15 Participants	—	—	—	—	—

Adverse Events

H5N1 Adjuvanted Group

Serious events: 25 serious events

Other events: 904 other events

Deaths: 1 deaths

H5N1 Un-adjuvanted Group

Serious events: 5 serious events

Other events: 159 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	H5N1 Adjuvanted Group n=961 participants at risk Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).	H5N1 Un-adjuvanted Group n=245 participants at risk Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.
General disorders Chills	10.9% 105/961 • Number of events 119 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).	2.9% 7/245 • Number of events 7 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).
General disorders Fatigue	58.2% 559/961 • Number of events 846 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).	37.1% 91/245 • Number of events 122 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).
General disorders Induration	25.6% 246/961 • Number of events 334 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).	4.5% 11/245 • Number of events 11 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).
General disorders Injection site erythema	33.4% 321/961 • Number of events 456 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).	19.6% 48/245 • Number of events 67 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).
General disorders Injection site pain	86.4% 830/961 • Number of events 1453 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).	25.3% 62/245 • Number of events 82 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).
General disorders Injection site swelling	38.0% 365/961 • Number of events 519 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).	9.4% 23/245 • Number of events 31 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).
General disorders Pyrexia	19.3% 185/961 • Number of events 213 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).	8.6% 21/245 • Number of events 26 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).
Musculoskeletal and connective tissue disorders Arthralgia	22.3% 214/961 • Number of events 268 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).	9.8% 24/245 • Number of events 30 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).
Musculoskeletal and connective tissue disorders Myalgia	63.5% 610/961 • Number of events 909 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).	26.5% 65/245 • Number of events 83 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).
Nervous system disorders Headache	40.5% 389/961 • Number of events 527 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).	24.1% 59/245 • Number of events 75 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).
Skin and subcutaneous tissue disorders Ecchymosis	7.1% 68/961 • Number of events 77 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).	4.1% 10/245 • Number of events 10 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).
Skin and subcutaneous tissue disorders Hyperhidrosis	14.9% 143/961 • Number of events 176 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).	10.2% 25/245 • Number of events 32 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).

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