Trial Outcomes & Findings for Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules (NCT NCT00652743)

Last Updated: 2018-08-02

Results Overview

GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

845 participants

Primary outcome timeframe

At Month 12 + 21 days

Results posted on

2018-08-02

Participant Flow

One enrolled subject was not administered a booster vaccination and hence not considered to have started the study.

Participant milestones

Participant milestones
Measure	GSK1562902A M6 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Months 12-18 STARTED	219	188	437
Months 12-18 COMPLETED	218	186	430
Months 12-18 NOT COMPLETED	1	2	7
Months 24-30 STARTED	212	186	433
Months 24-30 COMPLETED	207	185	422
Months 24-30 NOT COMPLETED	5	1	11
Months 36-42 STARTED	216	185	390
Months 36-42 COMPLETED	210	180	381
Months 36-42 NOT COMPLETED	6	5	9
Months 42-48 STARTED	196	170	367
Months 42-48 COMPLETED	196	170	367
Months 42-48 NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1562902A M6 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Months 12-18 Lost to Follow-up	1	2	7
Months 24-30 Other	5	1	11
Months 36-42 Serious Adverse Events	0	1	1
Months 36-42 Withdrawal by Subject	1	1	0
Months 36-42 Lost to Follow-up	0	1	0
Months 36-42 Migrated/moved from study area	1	0	0
Months 36-42 Other	4	2	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1562902A M6 Group n=219 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=188 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=437 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	Total n=844 Participants Total of all reporting groups
Age, Continuous	34.1 Years STANDARD_DEVIATION 10.33 • n=219 Participants	35.3 Years STANDARD_DEVIATION 9.23 • n=188 Participants	35.4 Years STANDARD_DEVIATION 9.71 • n=437 Participants	34.93 Years STANDARD_DEVIATION 9.75 • n=844 Participants
Sex: Female, Male Female	113 Participants n=219 Participants	97 Participants n=188 Participants	210 Participants n=437 Participants	420 Participants n=844 Participants
Sex: Female, Male Male	106 Participants n=219 Participants	91 Participants n=188 Participants	227 Participants n=437 Participants	424 Participants n=844 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: At Month 12 + 21 days

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=186 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Subjects Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value	178 Participants	—	—

PRIMARY outcome

Timeframe: At Month 12 + 21 days

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=186 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12	340.3 Titers Interval 282.8 to 409.6	—	—

PRIMARY outcome

Timeframe: At Month 36 + 21 days

Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=379 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Subjects Boosted at Month 36 With HI Antibody Concentrations Above the Cut-off Value	379 Participants	—	—

PRIMARY outcome

Timeframe: At Month 36 + 21 days

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=379 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36	877.5 Titers Interval 809.1 to 951.6	—	—

PRIMARY outcome

Timeframe: At Month 12 + 21 days

Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1).

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=180 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12	169 Participants	—	—

PRIMARY outcome

Timeframe: At Month 36 + 21 Days

Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1).

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=379 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36	378 Participants	—	—

PRIMARY outcome

Timeframe: At Month 12 + 21 days

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=180 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12	55.3 Fold change Interval 45.2 to 67.6	—	—

PRIMARY outcome

Timeframe: At Month 36 +21 days

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=379 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36	123.8 Fold change Interval 112.1 to 136.8	—	—

PRIMARY outcome

Timeframe: At Month 12 + 21 days

Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=186 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Subjects Boosted at Month 12 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease	178 Participants	—	—

PRIMARY outcome

Timeframe: At Month 36 + 21 days

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=379 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Subjects Boosted at Month 36 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease	379 Participants	—	—

SECONDARY outcome

Timeframe: At Months 18, 24, 30 and 36

Population: The analysis was performed on the ATP cohort for persistence at Month 12-18 (M12-18) and at Month 24-30 (M24-30), which included all evaluable subjects not boosted (M12-18) and boosted (M24-30) at M12, not boosted at M12 but boosted at M6 or neither boosted at M6 nor at M12 (M24-30).

Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=216 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=178 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=429 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Seropositive Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Month 18	178 Participants	0 Participants	146 Participants
Number of Seropositive Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Month 24	142 Participants	147 Participants	58 Participants
Number of Seropositive Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Month 30	144 Participants	149 Participants	73 Participants
Number of Seropositive Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Month 36	144 Participants	147 Participants	0 Participants
Number of Seropositive Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 18	176 Participants	0 Participants	173 Participants
Number of Seropositive Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 24	161 Participants	154 Participants	187 Participants
Number of Seropositive Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 30	154 Participants	158 Participants	168 Participants
Number of Seropositive Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 36	149 Participants	152 Participants	0 Participants

SECONDARY outcome

Timeframe: At Months 42 and 48

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=201 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=176 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=367 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Seropositive Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Month 42	127 Participants	143 Participants	0 Participants
Number of Seropositive Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Month 48	125 Participants	133 Participants	365 Participants
Number of Seropositive Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 42	138 Participants	149 Participants	0 Participants
Number of Seropositive Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 48	137 Participants	142 Participants	365 Participants

SECONDARY outcome

Timeframe: At Months 18, 24 and 30

Population: The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12.

Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4 fold the pre-booster antibody titer. The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=216 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=113 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 A/Vietnam/1194/2004, Month 30	28 Participants	51 Participants	—
Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 A/Indonesia/05/2005, Month 18	149 Participants	0 Participants	—
Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 A/Indonesia/05/2005, Month 24	48 Participants	70 Participants	—
Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 A/Indonesia/05/2005, Month 30	52 Participants	69 Participants	—
Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 A/Vietnam/1194/2004, Month 18	68 Participants	0 Participants	—
Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 A/Vietnam/1194/2004, Month 24	32 Participants	61 Participants	—

SECONDARY outcome

Timeframe: At Months 18, 24 and 30

Seroconversion was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=428 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies A/Indonesia/05/2005, Month 18	75 Participants	—	—
Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies A/Indonesia/05/2005, Month 24	6 Participants	—	—
Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies A/Indonesia/05/2005, Month 30	14 Participants	—	—
Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 18	61 Participants	—	—
Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 24	43 Participants	—	—
Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 30	58 Participants	—	—

SECONDARY outcome

Timeframe: At Months 36, 42 and 48

Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=208 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=172 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=367 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Booster Vaccine Response for H5N1 HI Antibodies A/Indonesia/05/2005, Month 36	91 Participants	115 Participants	0 Participants
Booster Vaccine Response for H5N1 HI Antibodies A/Indonesia/05/2005, Month 42	59 Participants	89 Participants	0 Participants
Booster Vaccine Response for H5N1 HI Antibodies A/Indonesia/05/2005, Month 48	62 Participants	88 Participants	339 Participants
Booster Vaccine Response for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 36	28 Participants	82 Participants	0 Participants
Booster Vaccine Response for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 42	22 Participants	69 Participants	0 Participants
Booster Vaccine Response for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 48	28 Participants	75 Participants	319 Participants

SECONDARY outcome

Timeframe: At Months 18, 24, 30

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=216 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=170 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=428 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies A/Indonesia/05/2005, Month 18	8.4 Fold change Interval 7.0 to 10.1	—	1.9 Fold change Interval 1.7 to 2.1
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies A/Indonesia/05/2005, Month 24	3.4 Fold change Interval 2.9 to 4.1	8.5 Fold change Interval 6.8 to 10.6	1.2 Fold change Interval 1.1 to 1.2
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies A/Indonesia/05/2005, Month 30	3.4 Fold change Interval 2.9 to 4.0	7.6 Fold change Interval 6.2 to 9.4	1.2 Fold change Interval 1.2 to 1.3
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 18	2.4 Fold change Interval 2.0 to 2.9	—	1.8 Fold change Interval 1.7 to 2.0
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 24	1.7 Fold change Interval 1.5 to 2.1	6.1 Fold change Interval 4.9 to 7.5	1.9 Fold change Interval 1.8 to 2.1
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 30	1.5 Fold change Interval 1.3 to 1.8	4.8 Fold change Interval 4.0 to 5.8	1.9 Fold change Interval 1.7 to 2.1

SECONDARY outcome

Timeframe: At Months 36, 42 and 48

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=208 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=172 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=367 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies A/Indonesia/05/2005, Month 36	3.8 Fold change Interval 3.2 to 4.5	8.6 Fold change Interval 6.9 to 10.7	—
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies A/Indonesia/05/2005, Month 42	2.8 Fold change Interval 2.4 to 3.2	6.0 Fold change Interval 4.9 to 7.4	—
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies A/Indonesia/05/2005, Month 48	3.0 Fold change Interval 2.6 to 3.6	6.1 Fold change Interval 5.0 to 7.5	24.0 Fold change Interval 21.5 to 26.9
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 36	1.3 Fold change Interval 1.1 to 1.6	4.5 Fold change Interval 3.7 to 5.5	—
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 42	1.1 Fold change Interval 0.9 to 1.3	3.4 Fold change Interval 2.8 to 4.1	—
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 48	1.2 Fold change Interval 1.0 to 1.5	3.7 Fold change Interval 3.0 to 4.5	15.2 Fold change Interval 13.4 to 17.1

SECONDARY outcome

Timeframe: At Months 18, 24 and 30

Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=216 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=177 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=429 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Month 18	157 Participants	0 Participants	75 Participants
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Month 24	88 Participants	117 Participants	10 Participants
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Month 30	95 Participants	120 Participants	16 Participants
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 18	149 Participants	0 Participants	79 Participants
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 24	115 Participants	135 Participants	67 Participants
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 30	107 Participants	128 Participants	88 Participants

SECONDARY outcome

Timeframe: At Months 36, 42 and 48

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=208 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=178 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=367 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Month 36	104 Participants	126 Participants	0 Participants
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Month 42	70 Participants	101 Participants	0 Participants
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Month 48	76 Participants	104 Participants	351 Participants
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 36	90 Participants	121 Participants	0 Participants
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 42	79 Participants	110 Participants	0 Participants
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Month 48	88 Participants	114 Participants	349 Participants

SECONDARY outcome

Timeframe: At Months 6/12, 6/12 + 21 days, 24, 36 and 48

Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=163 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=170 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=75 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Titers for Serum Neutralizing Antibodies A/Indonesia/05/2005, Month 6	179.7 Titers Interval 161.8 to 199.7	—	—
Titers for Serum Neutralizing Antibodies A/Indonesia/05/2005, Month 6/12/36 + 21 days	2702.0 Titers Interval 2270.4 to 3215.6	2363.2 Titers Interval 2037.5 to 2740.9	1154.3 Titers Interval 847.8 to 1571.4
Titers for Serum Neutralizing Antibodies A/Indonesia/05/2005, Month 12	134.0 Titers Interval 107.4 to 167.3	58.5 Titers Interval 50.8 to 67.3	—
Titers for Serum Neutralizing Antibodies A/Indonesia/05/2005, Month 24	66.3 Titers Interval 54.5 to 80.8	148.9 Titers Interval 111.8 to 198.3	16.7 Titers Interval 15.4 to 18.1
Titers for Serum Neutralizing Antibodies A/Indonesia/05/2005, Month 36	55.4 Titers Interval 45.5 to 67.6	106.9 Titers Interval 81.6 to 140.0	17.3 Titers Interval 15.8 to 19.0
Titers for Serum Neutralizing Antibodies A/Indonesia/05/2005, Month 48	54.5 Titers Interval 45.8 to 64.7	103.4 Titers Interval 79.5 to 134.4	320.4 Titers Interval 243.7 to 421.4
Titers for Serum Neutralizing Antibodies A/Vietnam/1194/2004, Month 6	169.9 Titers Interval 152.3 to 189.4	—	—
Titers for Serum Neutralizing Antibodies A/Vietnam/1194/2004, Month 6/12/36 + 21 days	1566.3 Titers Interval 1342.1 to 1827.9	2734.9 Titers Interval 2334.4 to 3204.2	1373.4 Titers Interval 1023.7 to 1842.6
Titers for Serum Neutralizing Antibodies A/Vietnam/1194/2004, Month 12	159.4 Titers Interval 128.1 to 198.2	204.1 Titers Interval 179.9 to 231.6	—
Titers for Serum Neutralizing Antibodies A/Vietnam/1194/2004, Month 24	74.0 Titers Interval 62.5 to 87.5	164.9 Titers Interval 125.7 to 216.2	33.3 Titers Interval 28.8 to 38.4
Titers for Serum Neutralizing Antibodies A/Vietnam/1194/2004, Month 36	62.0 Titers Interval 52.1 to 73.7	121.1 Titers Interval 91.7 to 159.9	31.8 Titers Interval 27.3 to 36.9
Titers for Serum Neutralizing Antibodies A/Vietnam/1194/2004, Month 48	71.4 Titers Interval 61.8 to 82.5	117.4 Titers Interval 92.7 to 148.6	429.0 Titers Interval 322.2 to 571.2

SECONDARY outcome

Timeframe: At Months 6/12/36 + 21 days, 12, 24, 36 and 48

Booster vaccine response was defined as: for pre-booster antibody titer \< 1:28, antibody titer ≥ 1:56 post-booster; for pre-booster, antibody titer ≥ 1:28, post-booster ≥ 4-fold the pre-booster antibody titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=163 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=164 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=75 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Booster Vaccine Response for Neutralizing Antibodies A/Indonesia/05/2005, Month 12	4 Participants	0 Participants	0 Participants
Booster Vaccine Response for Neutralizing Antibodies A/Indonesia/05/2005, Month 24	0 Participants	34 Participants	0 Participants
Booster Vaccine Response for Neutralizing Antibodies A/Indonesia/05/2005, Month 36	0 Participants	27 Participants	0 Participants
Booster Vaccine Response for Neutralizing Antibodies A/Indonesia/05/2005, Month 48	1 Participants	27 Participants	72 Participants
Booster Vaccine Response for Neutralizing Antibodies A/Indonesia/05/2005, Month 6/12/36 + 21 days	144 Participants	159 Participants	75 Participants
Booster Vaccine Response for Neutralizing Antibodies A/Vietnam/1194/2004, Month 12	7 Participants	0 Participants	0 Participants
Booster Vaccine Response for Neutralizing Antibodies A/Vietnam/1194/2004, Month 24	1 Participants	7 Participants	0 Participants
Booster Vaccine Response for Neutralizing Antibodies A/Vietnam/1194/2004, Month 36	0 Participants	5 Participants	0 Participants
Booster Vaccine Response for Neutralizing Antibodies A/Vietnam/1194/2004, Month 48	0 Participants	2 Participants	64 Participants
Booster Vaccine Response for Neutralizing Antibodies A/Vietnam/1194/2004, Month 6/12/36 + 21 days	121 Participants	141 Participants	73 Participants

SECONDARY outcome

Timeframe: At Months 6/12/36 + 21 days, 12, 24, 36 and 48

Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Indonesia/05/2005.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=162 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=170 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=75 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 6, ≥ 1:28	160 Participants	0 Participants	0 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 12, ≥ 1:28	74 Participants	135 Participants	0 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 24, ≥ 1:28	70 Participants	72 Participants	17 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 36, ≥ 1:28	66 Participants	69 Participants	19 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 48, ≥ 1:28	67 Participants	73 Participants	74 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 6/12/36 + 21 days, ≥ 1:28	162 Participants	170 Participants	75 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 6, ≥ 1:56	153 Participants	0 Participants	0 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 12, ≥ 1:56	70 Participants	99 Participants	0 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 24, ≥ 1:56	54 Participants	67 Participants	2 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 36, ≥ 1:56	48 Participants	58 Participants	4 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 48, ≥ 1:56	51 Participants	58 Participants	72 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 6/12/36 + 21 days, ≥ 1:56	162 Participants	170 Participants	74 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 6, ≥ 1:112	140 Participants	0 Participants	0 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 12, ≥ 1:112	50 Participants	45 Participants	0 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 24, ≥ 1:112	26 Participants	47 Participants	0 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 36, ≥ 1:112	24 Participants	41 Participants	0 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 48, ≥ 1:112	23 Participants	39 Participants	65 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Month 6/12/36 + 21 days, ≥ 1:112	161 Participants	170 Participants	71 Participants

SECONDARY outcome

Timeframe: At Months 6/12/36 + 21 days, 12, 24, 36 and 48

Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=163 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=170 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=75 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 36, ≥ 1:112	30 Participants	43 Participants	5 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 6/12/36 + 21 days, ≥ 1:112	163 Participants	170 Participants	72 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 6, ≥ 1:28	162 Participants	0 Participants	0 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 12, ≥ 1:28	75 Participants	162 Participants	0 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 24, ≥ 1:28	74 Participants	75 Participants	58 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 36, ≥ 1:28	71 Participants	73 Participants	55 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 48, ≥ 1:28	73 Participants	74 Participants	74 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 6/12/36 + 21 days, ≥ 1:28	163 Participants	170 Participants	74 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 6, ≥ 1:56	158 Participants	0 Participants	0 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 12, ≥ 1:56	74 Participants	155 Participants	0 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 24, ≥ 1:56	60 Participants	71 Participants	29 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 36, ≥ 1:56	52 Participants	60 Participants	27 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 48, ≥ 1:56	65 Participants	65 Participants	74 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 6/12/36 + 21 days, ≥ 1:56	163 Participants	170 Participants	74 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 6, ≥ 1:112	134 Participants	0 Participants	0 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 12, ≥ 1:112	59 Participants	137 Participants	0 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 24, ≥ 1:112	34 Participants	50 Participants	6 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Month 48, ≥ 1:112	30 Participants	48 Participants	68 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and Month 36

Population: The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available and who had their symptom sheets filled in.

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 = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=188 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=386 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	158 Participants	306 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Ecchymosis	2 Participants	1 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Ecchymosis	0 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Induration	17 Participants	23 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Induration	0 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	11 Participants	17 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	13 Participants	28 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	0 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	23 Participants	44 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and 36

Population: The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available and who has their symptom sheets filled in.

Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=188 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=386 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Any Arthralgia	48 Participants	99 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Grade 3 Arthralgia	6 Participants	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Related Arthralgia	45 Participants	95 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Any Fatigue	112 Participants	216 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Grade 3 Fatigue	12 Participants	19 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Related Fatigue	105 Participants	213 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Any Headache	76 Participants	138 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Grade 3 Headache	12 Participants	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Related Headache	69 Participants	134 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Any Myalgia	123 Participants	235 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Grade 3 Myalgia	14 Participants	17 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Related Myalgia	119 Participants	226 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Any Shivering	26 Participants	51 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Grade 3 Shivering	3 Participants	8 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Related Shivering	26 Participants	49 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Any Sweating	22 Participants	54 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Grade 3 Sweating	0 Participants	2 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Related Sweating	20 Participants	52 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Any Temperature	15 Participants	24 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Grade 3 Temperature	1 Participants	3 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom Related Temperature	14 Participants	23 Participants	—

SECONDARY outcome

Timeframe: During the entire study period (From Month 12 to Month 48)

Population: The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available.

An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=196 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=170 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=367 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Subjects With Adverse Events of Specific Interest (AESIs)	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days

Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Indonesia/05/2005.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=5 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=7 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=15 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-CD40L, Month 30	3113.00 T-cells/million cells Interval 2497.0 to 3729.0	3652.00 T-cells/million cells Interval 1296.0 to 4172.0	1685.00 T-cells/million cells Interval 1153.0 to 2195.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-CD40L, Month 6/12/36 + 21 days	5292.00 T-cells/million cells Interval 3027.0 to 8110.0	9416.00 T-cells/million cells Interval 4129.0 to 17348.0	5038.00 T-cells/million cells Interval 4283.0 to 7018.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IL-2, Month 12	2580.00 T-cells/million cells Interval 2290.0 to 2770.0	1649.00 T-cells/million cells Interval 1293.0 to 1865.0	1335.00 T-cells/million cells Interval 961.0 to 1859.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-All doubles, Month 6	1119.00 T-cells/million cells Interval 895.0 to 1343.0	1862.00 T-cells/million cells Interval 1836.0 to 2980.0	3109.50 T-cells/million cells Interval 2851.5 to 3576.5
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-All doubles, Month 12	2620.00 T-cells/million cells Interval 2422.0 to 2935.0	1599.00 T-cells/million cells Interval 1438.0 to 1929.0	1443.00 T-cells/million cells Interval 1065.0 to 2070.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-All doubles, Month 18	2060.00 T-cells/million cells Interval 1611.0 to 2263.0	2335.00 T-cells/million cells Interval 1820.0 to 4476.0	1590.00 T-cells/million cells Interval 1232.0 to 2010.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-All doubles, Month 24	2565.50 T-cells/million cells Interval 1890.5 to 3120.0	3517.00 T-cells/million cells Interval 1840.0 to 4567.0	1396.00 T-cells/million cells Interval 1259.0 to 1684.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-All doubles, Month 30	3147.50 T-cells/million cells Interval 2539.0 to 3756.0	3907.00 T-cells/million cells Interval 1281.0 to 4371.0	1670.00 T-cells/million cells Interval 1126.0 to 2256.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-All doubles, Month 36	1689.50 T-cells/million cells Interval 839.0 to 2649.0	2506.00 T-cells/million cells Interval 962.0 to 3842.0	995.00 T-cells/million cells Interval 849.0 to 1291.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-All doubles, Month 42	1656.00 T-cells/million cells Interval 877.0 to 2734.0	2311.00 T-cells/million cells Interval 1068.0 to 3328.0	2129.00 T-cells/million cells Interval 1597.0 to 2475.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-All doubles, Month 48	1496.00 T-cells/million cells Interval 1309.0 to 1878.0	2054.50 T-cells/million cells Interval 1404.0 to 4027.0	2064.00 T-cells/million cells Interval 1479.0 to 2906.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-All doubles, Month 6/12/36 + 21 days	5401.50 T-cells/million cells Interval 3071.0 to 8338.5	9553.00 T-cells/million cells Interval 4183.0 to 17658.0	5057.00 T-cells/million cells Interval 4388.0 to 7039.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-CD40L, Month 6	1045.00 T-cells/million cells Interval 817.0 to 1273.0	1792.00 T-cells/million cells Interval 1691.0 to 2986.0	2829.50 T-cells/million cells Interval 2605.5 to 3232.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-CD40L, Month 12	2634.00 T-cells/million cells Interval 2382.0 to 2917.0	1494.00 T-cells/million cells Interval 1425.0 to 1872.0	1372.00 T-cells/million cells Interval 1039.0 to 1991.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-CD40L, Month 18	2025.00 T-cells/million cells Interval 1609.0 to 2223.0	2240.00 T-cells/million cells Interval 1692.0 to 4454.0	1518.00 T-cells/million cells Interval 1148.0 to 1929.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-CD40L, Month 24	2583.00 T-cells/million cells Interval 1857.0 to 3135.5	3435.00 T-cells/million cells Interval 1801.0 to 4486.0	1395.00 T-cells/million cells Interval 1240.0 to 1724.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-CD40L, Month 36	1683.00 T-cells/million cells Interval 848.0 to 2642.5	2453.00 T-cells/million cells Interval 958.0 to 3867.0	975.00 T-cells/million cells Interval 849.0 to 1278.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-CD40L, Month 42	1656.00 T-cells/million cells Interval 873.0 to 2719.0	2243.00 T-cells/million cells Interval 1055.0 to 3311.0	2142.00 T-cells/million cells Interval 1584.0 to 2451.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-CD40L, Month 48	1496.00 T-cells/million cells Interval 1252.0 to 1799.0	2013.50 T-cells/million cells Interval 1418.0 to 3905.0	2008.00 T-cells/million cells Interval 1433.0 to 2856.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IFN-γ, Month 6	537.50 T-cells/million cells Interval 431.0 to 644.0	1189.00 T-cells/million cells Interval 862.0 to 1570.0	2134.00 T-cells/million cells Interval 1755.5 to 2525.5
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IFN-γ, Month 12	1217.00 T-cells/million cells Interval 1046.0 to 1782.0	994.00 T-cells/million cells Interval 607.0 to 1073.0	852.00 T-cells/million cells Interval 525.0 to 1081.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IFN-γ, Month 18	989.00 T-cells/million cells Interval 956.0 to 1206.0	1306.00 T-cells/million cells Interval 1049.0 to 2032.0	959.00 T-cells/million cells Interval 678.0 to 1151.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IFN-γ, Month 24	1590.50 T-cells/million cells Interval 1036.0 to 1905.0	2036.00 T-cells/million cells Interval 854.0 to 2315.0	787.00 T-cells/million cells Interval 655.0 to 947.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IFN-γ, Month 30	1829.00 T-cells/million cells Interval 1464.0 to 2194.0	1892.00 T-cells/million cells Interval 838.0 to 2466.0	1096.00 T-cells/million cells Interval 758.0 to 1330.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IFN-γ, Month 36	1026.00 T-cells/million cells Interval 481.0 to 1548.5	1452.00 T-cells/million cells Interval 606.0 to 2023.0	543.00 T-cells/million cells Interval 380.0 to 662.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IFN-γ, Month 42	698.00 T-cells/million cells Interval 349.0 to 1416.0	1336.00 T-cells/million cells Interval 568.0 to 1805.0	1119.00 T-cells/million cells Interval 714.0 to 1728.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IFN-γ, Month 48	964.00 T-cells/million cells Interval 721.0 to 1157.0	1085.00 T-cells/million cells Interval 787.0 to 2692.0	1334.00 T-cells/million cells Interval 553.0 to 1822.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IFN-γ, Month 6/12/36 + 21 days	3255.00 T-cells/million cells Interval 1676.0 to 4878.5	4661.50 T-cells/million cells Interval 1676.0 to 11231.0	2077.50 T-cells/million cells Interval 1745.0 to 2972.5
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IL-2, Month 6	883.50 T-cells/million cells Interval 612.0 to 1155.0	1657.00 T-cells/million cells Interval 1639.0 to 2798.0	2799.00 T-cells/million cells Interval 2495.5 to 3049.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IL-2, Month 18	1990.00 T-cells/million cells Interval 1430.0 to 2290.0	2297.00 T-cells/million cells Interval 1694.0 to 4071.0	1224.00 T-cells/million cells Interval 1164.0 to 1695.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IL-2, Month 24	2423.50 T-cells/million cells Interval 1653.5 to 2937.0	3256.00 T-cells/million cells Interval 1653.0 to 4370.0	1187.00 T-cells/million cells Interval 1107.0 to 1534.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IL-2, Month 30	2830.50 T-cells/million cells Interval 2319.0 to 3342.0	3459.00 T-cells/million cells Interval 1251.0 to 4078.0	1506.00 T-cells/million cells Interval 1037.0 to 2122.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IL-2, Month 36	1490.50 T-cells/million cells Interval 770.0 to 2396.0	2247.00 T-cells/million cells Interval 1015.0 to 3681.0	846.00 T-cells/million cells Interval 755.0 to 1077.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IL-2, Month 42	1533.00 T-cells/million cells Interval 801.0 to 2472.0	2123.00 T-cells/million cells Interval 1069.0 to 3248.0	2072.00 T-cells/million cells Interval 1472.0 to 2250.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IL-2, Month 48	1373.00 T-cells/million cells Interval 1115.0 to 1814.0	1906.00 T-cells/million cells Interval 1264.0 to 3659.0	1926.00 T-cells/million cells Interval 1292.0 to 2721.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-IL-2, Month 6/12/36 + 21 days	4972.50 T-cells/million cells Interval 2846.0 to 7782.5	8993.00 T-cells/million cells Interval 3979.0 to 16403.0	4532.00 T-cells/million cells Interval 4133.5 to 6494.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-TNF-α, Month 6	909.00 T-cells/million cells Interval 649.0 to 1169.0	1644.00 T-cells/million cells Interval 1334.0 to 2617.0	2579.00 T-cells/million cells Interval 2327.0 to 2985.5
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-TNF-α, Month 12	2528.00 T-cells/million cells Interval 2107.0 to 2752.0	1515.00 T-cells/million cells Interval 1346.0 to 1674.0	1174.00 T-cells/million cells Interval 975.0 to 2031.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-TNF-α, Month 18	1462.00 T-cells/million cells Interval 1459.0 to 1585.0	1810.00 T-cells/million cells Interval 1451.0 to 3453.0	1160.00 T-cells/million cells Interval 894.0 to 1492.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-TNF-α, Month 24	2084.50 T-cells/million cells Interval 1331.5 to 2414.5	2972.00 T-cells/million cells Interval 1281.0 to 4109.0	1107.00 T-cells/million cells Interval 1005.0 to 1333.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-TNF-α, Month 30	2442.50 T-cells/million cells Interval 2119.0 to 2766.0	3247.00 T-cells/million cells Interval 1042.0 to 3614.0	1269.00 T-cells/million cells Interval 1036.0 to 1889.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-TNF-α, Month 36	1476.50 T-cells/million cells Interval 697.5 to 2289.0	2291.00 T-cells/million cells Interval 951.0 to 3523.0	917.00 T-cells/million cells Interval 640.0 to 969.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-TNF-α, Month 42	1218.00 T-cells/million cells Interval 558.0 to 2068.0	1901.00 T-cells/million cells Interval 811.0 to 2695.0	1675.00 T-cells/million cells Interval 1218.0 to 2018.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-TNF-α, Month 48	1169.00 T-cells/million cells Interval 1028.0 to 1376.0	1769.50 T-cells/million cells Interval 1166.0 to 3244.0	1794.00 T-cells/million cells Interval 1106.0 to 2505.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD4-TNF-α, Month 6/12/36 + 21 days	4249.50 T-cells/million cells Interval 2151.5 to 6892.0	8466.00 T-cells/million cells Interval 3885.0 to 17018.0	3726.50 T-cells/million cells Interval 3454.5 to 5939.5

SECONDARY outcome

Timeframe: At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=5 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=7 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=15 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-TNF-α, Month 6	1280.50 T-cells/million cells Interval 803.0 to 1758.0	1768.00 T-cells/million cells Interval 1240.0 to 1938.0	2540.00 T-cells/million cells Interval 1451.5 to 2899.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-TNF-α, Month 12	1784.00 T-cells/million cells Interval 1683.0 to 3353.0	1488.00 T-cells/million cells Interval 925.0 to 1636.0	1404.00 T-cells/million cells Interval 1142.0 to 2111.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-CD40L, Month 48	1618.00 T-cells/million cells Interval 1387.0 to 2449.0	2008.50 T-cells/million cells Interval 1236.0 to 4383.0	2332.00 T-cells/million cells Interval 1451.0 to 2885.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-CD40L, Month 30	2882.00 T-cells/million cells Interval 2175.0 to 3589.0	3607.00 T-cells/million cells Interval 1908.0 to 5200.0	1449.00 T-cells/million cells Interval 1289.0 to 2123.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-CD40L, Month 36	1406.00 T-cells/million cells Interval 654.0 to 2475.0	2122.00 T-cells/million cells Interval 962.0 to 4049.0	1098.00 T-cells/million cells Interval 783.0 to 1328.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-CD40L, Month 42	1340.00 T-cells/million cells Interval 1174.0 to 2557.0	2265.00 T-cells/million cells Interval 1116.0 to 3800.0	2502.00 T-cells/million cells Interval 1638.0 to 2868.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-All doubles, Month 6	1615.50 T-cells/million cells Interval 918.0 to 2313.0	2133.00 T-cells/million cells Interval 1392.0 to 2727.0	3047.00 T-cells/million cells Interval 1913.0 to 3790.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-All doubles, Month 12	2410.00 T-cells/million cells Interval 2288.0 to 3872.0	1889.00 T-cells/million cells Interval 1263.0 to 2305.0	1849.50 T-cells/million cells Interval 1327.0 to 2605.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-All doubles, Month 18	2505.00 T-cells/million cells Interval 2491.0 to 2790.0	4073.00 T-cells/million cells Interval 2335.0 to 4833.0	1658.00 T-cells/million cells Interval 1301.0 to 1927.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-All doubles, Month 24	2720.00 T-cells/million cells Interval 1726.5 to 3263.5	3945.00 T-cells/million cells Interval 1666.0 to 4592.0	1472.00 T-cells/million cells Interval 1264.0 to 1906.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-All doubles, Month 30	2959.50 T-cells/million cells Interval 2252.0 to 3667.0	3713.00 T-cells/million cells Interval 1996.0 to 5220.0	1478.00 T-cells/million cells Interval 1275.0 to 2210.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-All doubles, Month 36	1420.00 T-cells/million cells Interval 645.0 to 2468.0	2149.00 T-cells/million cells Interval 977.0 to 4081.0	1097.00 T-cells/million cells Interval 836.0 to 1395.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-All doubles, Month 42	1354.00 T-cells/million cells Interval 1190.0 to 2571.0	2264.00 T-cells/million cells Interval 1157.0 to 3817.0	2555.00 T-cells/million cells Interval 1665.0 to 2882.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-All doubles, Month 48	1600.00 T-cells/million cells Interval 1374.0 to 2493.0	2087.50 T-cells/million cells Interval 1236.0 to 4476.0	2332.00 T-cells/million cells Interval 1451.0 to 3052.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-All doubles, Month 6/12/36 + 21 days	7067.50 T-cells/million cells Interval 3359.5 to 10769.5	10061.50 T-cells/million cells Interval 4553.0 to 18155.0	5315.50 T-cells/million cells Interval 4283.5 to 7167.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-CD40L, Month 6	1586.00 T-cells/million cells Interval 857.0 to 2315.0	1998.00 T-cells/million cells Interval 1335.0 to 2496.0	2937.50 T-cells/million cells Interval 1851.0 to 3612.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-CD40L, Month 12	2384.00 T-cells/million cells Interval 2257.0 to 3832.0	1863.00 T-cells/million cells Interval 1206.0 to 2249.0	1741.50 T-cells/million cells Interval 1327.0 to 2484.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-CD40L, Month 18	2517.00 T-cells/million cells Interval 2456.0 to 2776.0	3980.00 T-cells/million cells Interval 2294.0 to 4803.0	1607.00 T-cells/million cells Interval 1274.0 to 1819.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-CD40L, Month 24	2735.50 T-cells/million cells Interval 1693.0 to 3280.5	3932.00 T-cells/million cells Interval 1667.0 to 4539.0	1490.00 T-cells/million cells Interval 1279.0 to 1933.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-CD40L, Month 6/12/36 + 21 days	6931.00 T-cells/million cells Interval 3256.0 to 10610.5	9587.00 T-cells/million cells Interval 4451.0 to 17713.0	5296.00 T-cells/million cells Interval 4267.0 to 7144.5
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IFN-γ, Month 6	826.00 T-cells/million cells Interval 365.0 to 1287.0	999.00 T-cells/million cells Interval 452.0 to 1623.0	1420.00 T-cells/million cells Interval 948.0 to 2423.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IFN-γ, Month 12	1108.00 T-cells/million cells Interval 876.0 to 2433.0	884.00 T-cells/million cells Interval 608.0 to 925.0	869.50 T-cells/million cells Interval 633.0 to 1329.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IFN-γ, Month 18	1395.00 T-cells/million cells Interval 1047.0 to 1573.0	1927.00 T-cells/million cells Interval 1061.0 to 2642.0	941.00 T-cells/million cells Interval 548.0 to 1263.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IFN-γ, Month 24	1659.00 T-cells/million cells Interval 1046.0 to 1846.0	2439.00 T-cells/million cells Interval 613.0 to 2625.0	847.00 T-cells/million cells Interval 658.0 to 1112.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IFN-γ, Month 30	1885.50 T-cells/million cells Interval 1473.0 to 2298.0	2248.00 T-cells/million cells Interval 1264.0 to 2469.0	1074.00 T-cells/million cells Interval 859.0 to 1155.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IFN-γ, Month 36	813.50 T-cells/million cells Interval 436.0 to 1244.0	1260.00 T-cells/million cells Interval 512.0 to 2163.0	621.00 T-cells/million cells Interval 526.0 to 730.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IFN-γ, Month 42	547.00 T-cells/million cells Interval 546.0 to 1515.0	1218.00 T-cells/million cells Interval 449.0 to 2058.0	1228.00 T-cells/million cells Interval 949.0 to 1682.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IFN-γ, Month 48	749.00 T-cells/million cells Interval 697.0 to 1682.0	1007.00 T-cells/million cells Interval 646.0 to 2797.0	1223.00 T-cells/million cells Interval 658.0 to 1866.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IFN-γ, Month 6/12/36 + 21 days	3608.50 T-cells/million cells Interval 1467.5 to 5510.5	4918.00 T-cells/million cells Interval 1852.0 to 9857.0	2142.00 T-cells/million cells Interval 1763.5 to 2954.5
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IL-2, Month 6	1493.00 T-cells/million cells Interval 952.0 to 2034.0	1957.00 T-cells/million cells Interval 1382.0 to 2522.0	2910.50 T-cells/million cells Interval 1768.5 to 3368.5
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IL-2, Month 12	2305.00 T-cells/million cells Interval 2075.0 to 3663.0	1729.00 T-cells/million cells Interval 1286.0 to 2197.0	1759.00 T-cells/million cells Interval 1393.0 to 2469.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IL-2, Month 18	2431.00 T-cells/million cells Interval 2425.0 to 2750.0	4073.00 T-cells/million cells Interval 2281.0 to 4495.0	1592.00 T-cells/million cells Interval 1235.0 to 1833.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IL-2, Month 24	2598.00 T-cells/million cells Interval 1545.5 to 3129.5	3799.00 T-cells/million cells Interval 1480.0 to 4419.0	1454.00 T-cells/million cells Interval 1093.0 to 1693.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IL-2, Month 30	2773.00 T-cells/million cells Interval 2137.0 to 3409.0	3537.00 T-cells/million cells Interval 1910.0 to 5234.0	1344.00 T-cells/million cells Interval 1262.0 to 2086.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IL-2, Month 36	1301.00 T-cells/million cells Interval 674.5 to 2268.0	2240.00 T-cells/million cells Interval 798.0 to 3945.0	891.00 T-cells/million cells Interval 808.0 to 1247.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IL-2, Month 42	1218.00 T-cells/million cells Interval 1125.0 to 2362.0	2179.00 T-cells/million cells Interval 1075.0 to 3878.0	2323.00 T-cells/million cells Interval 1693.0 to 2676.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IL-2, Month 48	1169.00 T-cells/million cells Interval 966.0 to 2422.0	1931.50 T-cells/million cells Interval 1151.0 to 3830.0	2218.00 T-cells/million cells Interval 1271.0 to 2642.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-IL-2, Month 6/12/36 + 21 days	6557.00 T-cells/million cells Interval 3110.5 to 9871.0	9252.00 T-cells/million cells Interval 4333.0 to 17247.0	4759.50 T-cells/million cells Interval 3940.5 to 6757.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-TNF-α, Month 18	2258.00 T-cells/million cells Interval 2147.0 to 2346.0	3357.00 T-cells/million cells Interval 1879.0 to 4452.0	1392.00 T-cells/million cells Interval 996.0 to 1518.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-TNF-α, Month 24	1871.00 T-cells/million cells Interval 1145.5 to 2420.0	3252.00 T-cells/million cells Interval 1107.0 to 4049.0	1131.00 T-cells/million cells Interval 934.0 to 1419.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-TNF-α, Month 30	2191.00 T-cells/million cells Interval 1720.0 to 2662.0	3246.00 T-cells/million cells Interval 1438.0 to 4397.0	1246.00 T-cells/million cells Interval 987.0 to 1662.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-TNF-α, Month 36	1145.00 T-cells/million cells Interval 501.0 to 1974.0	1935.00 T-cells/million cells Interval 820.0 to 3658.0	829.00 T-cells/million cells Interval 569.0 to 1071.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-TNF-α, Month 42	1094.00 T-cells/million cells Interval 818.0 to 2000.0	1819.00 T-cells/million cells Interval 858.0 to 3069.0	1863.00 T-cells/million cells Interval 1390.0 to 2182.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-TNF-α, Month 48	1376.00 T-cells/million cells Interval 1197.0 to 1769.0	1737.00 T-cells/million cells Interval 941.0 to 3622.0	1781.00 T-cells/million cells Interval 1203.0 to 2307.0
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD4-TNF-α, Month 6/12/36 + 21 days	5527.50 T-cells/million cells Interval 2298.0 to 8633.5	7385.50 T-cells/million cells Interval 3438.0 to 16134.0	3899.00 T-cells/million cells Interval 3218.0 to 6044.5

SECONDARY outcome

Timeframe: At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days

Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Indonesia/05/2005.

Outcome measures

SECONDARY outcome

Timeframe: At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days

Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Vietnam/1194/2004.

Outcome measures

SECONDARY outcome

Timeframe: During the 30-day (Days 0-29) follow-up period after vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available.

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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK1562902A M12 Group n=188 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=390 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	44 Participants	85 Participants	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	6 Participants	9 Participants	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	22 Participants	34 Participants	—

SECONDARY outcome

Timeframe: During the entire study period (From Month 12 up to Month 48)

Population: The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available.

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	GSK1562902A M12 Group n=219 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=188 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=437 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Subjects With Serious Adverse Events (SAEs) Month 12 to Month 48	14 Participants	13 Participants	28 Participants
Number of Subjects With Serious Adverse Events (SAEs) Month 42 to Month 48	2 Participants	3 Participants	4 Participants

Adverse Events

GSK1562902A M6 Group

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

GSK1562902A M12 Group

Serious events: 13 serious events

Other events: 169 other events

Deaths: 0 deaths

GSK1562902A M36 Group

Serious events: 28 serious events

Other events: 336 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK1562902A M6 Group n=219 participants at risk Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=188 participants at risk Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=437 participants at risk Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Musculoskeletal and connective tissue disorders Arthralgia	— 0/0 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	25.5% 48/188 • Number of events 48 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	22.7% 99/437 • Number of events 100 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.
General disorders Chills	— 0/0 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	13.8% 26/188 • Number of events 26 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	11.7% 51/437 • Number of events 51 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.
Skin and subcutaneous tissue disorders Erythema	— 0/0 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	6.9% 13/188 • Number of events 13 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	6.4% 28/437 • Number of events 28 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.
General disorders Fatigue	— 0/0 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	60.1% 113/188 • Number of events 113 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	49.4% 216/437 • Number of events 216 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.
Nervous system disorders Headache	— 0/0 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	40.4% 76/188 • Number of events 77 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	31.8% 139/437 • Number of events 140 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.
Skin and subcutaneous tissue disorders Hyperhidrosis	— 0/0 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	11.7% 22/188 • Number of events 22 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	12.4% 54/437 • Number of events 54 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.
General disorders Induration	— 0/0 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	9.0% 17/188 • Number of events 17 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	5.3% 23/437 • Number of events 23 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.
Musculoskeletal and connective tissue disorders Myalgia	— 0/0 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	65.4% 123/188 • Number of events 123 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	53.8% 235/437 • Number of events 235 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.
General disorders Pain	— 0/0 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	84.0% 158/188 • Number of events 158 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	70.0% 306/437 • Number of events 308 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.
General disorders Pyrexia	— 0/0 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	9.0% 17/188 • Number of events 18 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	5.5% 24/437 • Number of events 24 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.
General disorders Swelling	— 0/0 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	12.2% 23/188 • Number of events 23 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.	10.1% 44/437 • Number of events 44 • SAEs, AESIs : During the entire study period (From Month 12 to Month 48); Solicited local AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and Month 36; Solicited general AEs: During the 7-day (Days 0-6) post-vaccination period for subjects boosted at Month 12 and 36; Unsolicited AEs: During the 30-day (Days 0-29) follow-up period after vaccination. Non serious AEs (solicited local/ general/ unsolicited) were collected for M6 subset and are reported in study 109630 (NC T00449670) during which they received their booster vaccination.

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

Measure	GSK1562902A M12 Group n=5 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=7 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=15 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-All doubles, Month 48	30.00 T-cells/million cells Interval 1.0 to 59.0	20.50 T-cells/million cells Interval 1.0 to 86.0	1.00 T-cells/million cells Interval 1.0 to 60.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-TNF-α, Month 18	1.00 T-cells/million cells Interval 1.0 to 1.0	60.00 T-cells/million cells Interval 1.0 to 81.0	10.00 T-cells/million cells Interval 1.0 to 219.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-All doubles, Month 6	34.50 T-cells/million cells Interval 26.0 to 43.0	1.00 T-cells/million cells Interval 1.0 to 42.0	14.00 T-cells/million cells Interval 7.0 to 48.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-All doubles, Month 12	1.00 T-cells/million cells Interval 1.0 to 4.0	26.00 T-cells/million cells Interval 1.0 to 111.0	44.00 T-cells/million cells Interval 1.0 to 141.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-All doubles, Month 18	1.00 T-cells/million cells Interval 1.0 to 1.0	120.00 T-cells/million cells Interval 27.0 to 139.0	27.00 T-cells/million cells Interval 1.0 to 220.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-All doubles, Month 24	23.00 T-cells/million cells Interval 1.0 to 73.0	51.00 T-cells/million cells Interval 1.0 to 134.0	88.00 T-cells/million cells Interval 41.0 to 208.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-All doubles, Month 30	2.50 T-cells/million cells Interval 1.0 to 4.0	1.00 T-cells/million cells Interval 1.0 to 2.0	37.00 T-cells/million cells Interval 1.0 to 47.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-All doubles, Month 36	38.50 T-cells/million cells Interval 14.0 to 52.0	17.00 T-cells/million cells Interval 1.0 to 78.0	35.00 T-cells/million cells Interval 1.0 to 77.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-All doubles, Month 42	19.00 T-cells/million cells Interval 1.0 to 23.0	3.00 T-cells/million cells Interval 1.0 to 24.0	1.00 T-cells/million cells Interval 1.0 to 42.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-All doubles, Month 6/12/36 + 21 days	73.00 T-cells/million cells Interval 26.5 to 130.5	159.50 T-cells/million cells Interval 93.0 to 217.0	45.50 T-cells/million cells Interval 22.5 to 101.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-CD40L, Month 6	34.00 T-cells/million cells Interval 25.0 to 43.0	1.00 T-cells/million cells Interval 1.0 to 68.0	3.50 T-cells/million cells Interval 1.0 to 8.5
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-CD40L, Month 12	1.00 T-cells/million cells Interval 1.0 to 95.0	1.00 T-cells/million cells Interval 1.0 to 111.0	1.00 T-cells/million cells Interval 1.0 to 75.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-CD40L, Month 18	1.00 T-cells/million cells Interval 1.0 to 1.0	9.00 T-cells/million cells Interval 1.0 to 36.0	1.00 T-cells/million cells Interval 1.0 to 22.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-CD40L, Month 24	55.50 T-cells/million cells Interval 8.5 to 112.0	32.00 T-cells/million cells Interval 26.0 to 35.0	61.00 T-cells/million cells Interval 1.0 to 91.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-CD40L, Month 30	3.00 T-cells/million cells Interval 1.0 to 5.0	1.00 T-cells/million cells Interval 1.0 to 3.0	1.00 T-cells/million cells Interval 1.0 to 16.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-CD40L, Month 36	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 19.0	1.00 T-cells/million cells Interval 1.0 to 20.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-CD40L, Month 42	1.00 T-cells/million cells Interval 1.0 to 9.0	1.00 T-cells/million cells Interval 1.0 to 13.0	1.00 T-cells/million cells Interval 1.0 to 1.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-CD40L, Month 48	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 3.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-CD40L, Month 6/12/36 + 21 days	78.50 T-cells/million cells Interval 39.0 to 96.5	28.00 T-cells/million cells Interval 1.0 to 102.0	30.50 T-cells/million cells Interval 1.0 to 41.5
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IFN-γ, Month 6	22.00 T-cells/million cells Interval 1.0 to 43.0	1.00 T-cells/million cells Interval 1.0 to 42.0	8.00 T-cells/million cells Interval 1.0 to 48.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IFN-γ, Month 12	1.00 T-cells/million cells Interval 1.0 to 44.0	54.00 T-cells/million cells Interval 1.0 to 86.0	1.00 T-cells/million cells Interval 1.0 to 91.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IFN-γ, Month 18	1.00 T-cells/million cells Interval 1.0 to 3.0	120.00 T-cells/million cells Interval 36.0 to 139.0	27.00 T-cells/million cells Interval 1.0 to 220.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IFN-γ, Month 24	23.00 T-cells/million cells Interval 1.0 to 55.5	30.00 T-cells/million cells Interval 1.0 to 117.0	95.00 T-cells/million cells Interval 41.0 to 142.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IFN-γ, Month 30	2.50 T-cells/million cells Interval 1.0 to 4.0	1.00 T-cells/million cells Interval 1.0 to 2.0	18.00 T-cells/million cells Interval 1.0 to 26.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IFN-γ, Month 36	38.50 T-cells/million cells Interval 19.0 to 52.0	25.00 T-cells/million cells Interval 3.0 to 39.0	20.00 T-cells/million cells Interval 1.0 to 77.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IFN-γ, Month 42	1.00 T-cells/million cells Interval 1.0 to 9.0	1.00 T-cells/million cells Interval 1.0 to 3.0	1.00 T-cells/million cells Interval 1.0 to 27.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IFN-γ, Month 48	1.00 T-cells/million cells Interval 1.0 to 1.0	29.00 T-cells/million cells Interval 1.0 to 86.0	1.00 T-cells/million cells Interval 1.0 to 60.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IFN-γ, Month 6/12/36 + 21 days	59.50 T-cells/million cells Interval 26.5 to 117.0	93.50 T-cells/million cells Interval 1.0 to 165.0	35.00 T-cells/million cells Interval 1.0 to 65.5
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IL-2, Month 6	12.50 T-cells/million cells Interval 1.0 to 24.0	1.00 T-cells/million cells Interval 1.0 to 34.0	32.00 T-cells/million cells Interval 16.0 to 36.5
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IL-2, Month 12	1.00 T-cells/million cells Interval 1.0 to 47.0	1.00 T-cells/million cells Interval 1.0 to 27.0	31.00 T-cells/million cells Interval 1.0 to 184.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IL-2, Month 18	1.00 T-cells/million cells Interval 1.0 to 1.0	47.00 T-cells/million cells Interval 9.0 to 78.0	27.50 T-cells/million cells Interval 1.0 to 161.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IL-2, Month 24	5.00 T-cells/million cells Interval 1.0 to 13.5	1.00 T-cells/million cells Interval 1.0 to 19.0	39.00 T-cells/million cells Interval 24.0 to 60.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IL-2, Month 30	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 3.0	16.00 T-cells/million cells Interval 1.0 to 36.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IL-2, Month 36	38.50 T-cells/million cells Interval 14.0 to 52.0	17.00 T-cells/million cells Interval 1.0 to 58.0	20.00 T-cells/million cells Interval 1.0 to 38.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IL-2, Month 42	19.00 T-cells/million cells Interval 1.0 to 23.0	13.00 T-cells/million cells Interval 1.0 to 24.0	1.00 T-cells/million cells Interval 1.0 to 42.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IL-2, Month 48	30.00 T-cells/million cells Interval 1.0 to 55.0	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 44.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-IL-2, Month 6/12/36 + 21 days	28.00 T-cells/million cells Interval 13.5 to 34.0	144.00 T-cells/million cells Interval 76.0 to 207.0	35.00 T-cells/million cells Interval 1.0 to 69.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-TNF-α, Month 6	12.50 T-cells/million cells Interval 1.0 to 24.0	1.00 T-cells/million cells Interval 1.0 to 55.0	50.50 T-cells/million cells Interval 16.5 to 86.5
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-TNF-α, Month 12	1.00 T-cells/million cells Interval 1.0 to 23.0	28.00 T-cells/million cells Interval 1.0 to 79.0	31.00 T-cells/million cells Interval 1.0 to 69.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-TNF-α, Month 24	17.00 T-cells/million cells Interval 1.0 to 42.0	78.00 T-cells/million cells Interval 1.0 to 161.0	76.00 T-cells/million cells Interval 21.0 to 142.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-TNF-α, Month 30	8.00 T-cells/million cells Interval 1.0 to 15.0	1.00 T-cells/million cells Interval 1.0 to 1.0	36.00 T-cells/million cells Interval 1.0 to 82.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-TNF-α, Month 36	14.00 T-cells/million cells Interval 1.0 to 38.5	1.00 T-cells/million cells Interval 1.0 to 58.0	1.00 T-cells/million cells Interval 1.0 to 21.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-TNF-α, Month 42	19.00 T-cells/million cells Interval 1.0 to 23.0	1.00 T-cells/million cells Interval 1.0 to 24.0	1.00 T-cells/million cells Interval 1.0 to 27.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-TNF-α, Month 48	30.00 T-cells/million cells Interval 1.0 to 59.0	1.00 T-cells/million cells Interval 1.0 to 86.0	1.00 T-cells/million cells Interval 1.0 to 30.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) CD8-TNF-α, Month 6/12/36 + 21 days	26.00 T-cells/million cells Interval 13.5 to 53.0	112.50 T-cells/million cells Interval 81.0 to 194.0	46.00 T-cells/million cells Interval 20.0 to 101.0

Measure	GSK1562902A M12 Group n=5 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M12 Group n=7 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.	GSK1562902A M36 Group n=15 Participants Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-All doubles, Month 48	12.00 T-cells/million cells Interval 1.0 to 55.0	1.50 T-cells/million cells Interval 1.0 to 20.0	19.00 T-cells/million cells Interval 1.0 to 42.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-CD40L, Month 6/12/36 + 21 days	10.00 T-cells/million cells Interval 1.0 to 37.5	1.00 T-cells/million cells Interval 1.0 to 64.0	1.00 T-cells/million cells Interval 1.0 to 28.5
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IFN-γ, Month 6	33.00 T-cells/million cells Interval 1.0 to 65.0	22.00 T-cells/million cells Interval 1.0 to 64.0	1.00 T-cells/million cells Interval 1.0 to 32.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-TNF-α, Month 36	23.00 T-cells/million cells Interval 1.0 to 133.0	111.00 T-cells/million cells Interval 1.0 to 142.0	1.00 T-cells/million cells Interval 1.0 to 67.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-All doubles, Month 6	33.00 T-cells/million cells Interval 1.0 to 65.0	69.00 T-cells/million cells Interval 1.0 to 91.0	1.00 T-cells/million cells Interval 1.0 to 60.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-All doubles, Month 12	26.00 T-cells/million cells Interval 1.0 to 32.0	24.00 T-cells/million cells Interval 21.0 to 106.0	24.00 T-cells/million cells Interval 1.0 to 92.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-All doubles, Month 18	1.00 T-cells/million cells Interval 1.0 to 1.0	63.00 T-cells/million cells Interval 22.0 to 120.0	30.00 T-cells/million cells Interval 1.0 to 87.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-All doubles, Month 24	28.50 T-cells/million cells Interval 7.5 to 50.0	33.00 T-cells/million cells Interval 1.0 to 48.0	52.00 T-cells/million cells Interval 1.0 to 256.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-All doubles, Month 30	1.00 T-cells/million cells Interval 1.0 to 1.0	46.00 T-cells/million cells Interval 1.0 to 55.0	4.00 T-cells/million cells Interval 1.0 to 85.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-All doubles, Month 36	18.00 T-cells/million cells Interval 1.0 to 183.0	96.00 T-cells/million cells Interval 1.0 to 195.0	30.00 T-cells/million cells Interval 1.0 to 71.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-All doubles, Month 42	1.00 T-cells/million cells Interval 1.0 to 31.0	35.00 T-cells/million cells Interval 1.0 to 38.0	26.00 T-cells/million cells Interval 1.0 to 57.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-All doubles, Month 6/12/36 + 21 days	32.50 T-cells/million cells Interval 14.0 to 47.0	133.50 T-cells/million cells Interval 21.0 to 358.0	33.00 T-cells/million cells Interval 1.0 to 210.5
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-CD40L, Month 6	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 23.5
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-CD40L, Month 12	12.00 T-cells/million cells Interval 1.0 to 18.0	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 1.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-CD40L, Month 18	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 12.0	1.00 T-cells/million cells Interval 1.0 to 19.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-CD40L, Month 24	21.50 T-cells/million cells Interval 14.5 to 54.0	33.00 T-cells/million cells Interval 8.0 to 48.0	17.00 T-cells/million cells Interval 1.0 to 37.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-CD40L, Month 30	1.00 T-cells/million cells Interval 1.0 to 1.0	31.00 T-cells/million cells Interval 1.0 to 49.0	1.00 T-cells/million cells Interval 1.0 to 1.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-CD40L, Month 36	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 18.0	4.00 T-cells/million cells Interval 1.0 to 33.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-CD40L, Month 42	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 18.0	1.00 T-cells/million cells Interval 1.0 to 20.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-CD40L, Month 48	1.00 T-cells/million cells Interval 1.0 to 28.0	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 1.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IFN-γ, Month 12	18.00 T-cells/million cells Interval 1.0 to 26.0	67.00 T-cells/million cells Interval 20.0 to 156.0	30.50 T-cells/million cells Interval 1.0 to 93.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IFN-γ, Month 18	1.00 T-cells/million cells Interval 1.0 to 1.0	30.00 T-cells/million cells Interval 1.0 to 149.0	2.00 T-cells/million cells Interval 1.0 to 71.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IFN-γ, Month 24	10.00 T-cells/million cells Interval 1.0 to 48.5	33.00 T-cells/million cells Interval 16.0 to 79.0	51.00 T-cells/million cells Interval 1.0 to 273.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IFN-γ, Month 30	1.00 T-cells/million cells Interval 1.0 to 1.0	46.00 T-cells/million cells Interval 1.0 to 55.0	1.00 T-cells/million cells Interval 1.0 to 85.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IFN-γ, Month 36	23.00 T-cells/million cells Interval 1.0 to 188.0	96.00 T-cells/million cells Interval 24.0 to 159.0	4.00 T-cells/million cells Interval 1.0 to 39.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IFN-γ, Month 42	1.00 T-cells/million cells Interval 1.0 to 23.0	35.00 T-cells/million cells Interval 1.0 to 38.0	20.00 T-cells/million cells Interval 1.0 to 41.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IFN-γ, Month 48	1.00 T-cells/million cells Interval 1.0 to 12.0	1.00 T-cells/million cells Interval 1.0 to 20.0	35.00 T-cells/million cells Interval 1.0 to 49.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IFN-γ, Month 6/12/36 + 21 days	27.50 T-cells/million cells Interval 14.0 to 33.5	81.00 T-cells/million cells Interval 21.0 to 293.0	25.50 T-cells/million cells Interval 1.0 to 146.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IL-2, Month 6	3.50 T-cells/million cells Interval 1.0 to 6.0	67.00 T-cells/million cells Interval 1.0 to 68.0	28.00 T-cells/million cells Interval 2.0 to 56.5
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IL-2, Month 12	25.00 T-cells/million cells Interval 19.0 to 32.0	53.00 T-cells/million cells Interval 8.0 to 79.0	7.50 T-cells/million cells Interval 1.0 to 57.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IL-2, Month 18	1.00 T-cells/million cells Interval 1.0 to 1.0	47.00 T-cells/million cells Interval 1.0 to 60.0	2.00 T-cells/million cells Interval 1.0 to 45.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IL-2, Month 24	1.00 T-cells/million cells Interval 1.0 to 19.5	12.00 T-cells/million cells Interval 1.0 to 39.0	51.00 T-cells/million cells Interval 1.0 to 114.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IL-2, Month 30	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 24.0	19.00 T-cells/million cells Interval 1.0 to 113.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IL-2, Month 36	1.00 T-cells/million cells Interval 1.0 to 138.5	64.00 T-cells/million cells Interval 1.0 to 124.0	1.00 T-cells/million cells Interval 1.0 to 33.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IL-2, Month 42	1.00 T-cells/million cells Interval 1.0 to 11.0	1.00 T-cells/million cells Interval 1.0 to 38.0	20.00 T-cells/million cells Interval 1.0 to 44.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IL-2, Month 48	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 22.0	1.00 T-cells/million cells Interval 1.0 to 3.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-IL-2, Month 6/12/36 + 21 days	23.00 T-cells/million cells Interval 15.5 to 30.0	103.50 T-cells/million cells Interval 1.0 to 227.0	39.00 T-cells/million cells Interval 1.0 to 104.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-TNF-α, Month 6	29.00 T-cells/million cells Interval 1.0 to 57.0	25.00 T-cells/million cells Interval 1.0 to 91.0	32.50 T-cells/million cells Interval 1.0 to 46.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-TNF-α, Month 12	1.00 T-cells/million cells Interval 1.0 to 1.0	24.00 T-cells/million cells Interval 8.0 to 80.0	39.50 T-cells/million cells Interval 1.0 to 69.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-TNF-α, Month 18	1.00 T-cells/million cells Interval 1.0 to 1.0	63.00 T-cells/million cells Interval 15.0 to 95.0	19.00 T-cells/million cells Interval 1.0 to 71.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-TNF-α, Month 24	45.50 T-cells/million cells Interval 26.5 to 61.0	37.00 T-cells/million cells Interval 33.0 to 52.0	77.00 T-cells/million cells Interval 1.0 to 200.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-TNF-α, Month 30	10.50 T-cells/million cells Interval 1.0 to 20.0	1.00 T-cells/million cells Interval 1.0 to 55.0	39.00 T-cells/million cells Interval 2.0 to 85.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-TNF-α, Month 42	1.00 T-cells/million cells Interval 1.0 to 1.0	1.00 T-cells/million cells Interval 1.0 to 18.0	20.00 T-cells/million cells Interval 1.0 to 57.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-TNF-α, Month 48	1.00 T-cells/million cells Interval 1.0 to 12.0	1.00 T-cells/million cells Interval 1.0 to 20.0	20.00 T-cells/million cells Interval 1.0 to 29.0
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) CD8-TNF-α, Month 6/12/36 + 21 days	15.50 T-cells/million cells Interval 7.0 to 23.0	127.00 T-cells/million cells Interval 21.0 to 227.0	7.50 T-cells/million cells Interval 1.0 to 162.5