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

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

Time frame: Before vaccination (Day 0)

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

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

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

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

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

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

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

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

Time frame: At Month 12

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

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

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

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

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

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

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

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

Time frame: At Month 6 and Month 12

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

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

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

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

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

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

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

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

Time frame: At Month 6 and at Month 12

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

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

Time frame: At Day 21 (D21) and at Day 42 (D42)

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

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

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

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

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

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

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

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

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

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

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

Time frame: At Month 12

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

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

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

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

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

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

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

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

Time frame: At Month 12

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

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

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

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

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

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

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

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

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

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

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

Time frame: At Day 0, Day 21, Day 42, Month 6 and Month 12

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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.

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

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

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.

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

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

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

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

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

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

Time frame: From Month 6 to Month 12

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

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

Time frame: At day 21 and Day 42

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

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

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

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

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

Time frame: At Day 21, at Day 42, at Month 6 and at Month 12

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Time frame: At Month 12

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

Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28.

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

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