| Primary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Before vaccination (Day 0) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group - Lot 1 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Adjuvanted Group - Lot 2 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG002 | H5N1 Adjuvanted Group - Lot 3 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 3) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG003 | H5N1 Adjuvanted Group - Lot 4 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG004 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
| | Units | Counts |
|---|
| Participants | - OG000233
- OG001235
- OG002231
- OG003
|
| | Title | Denominators | Categories |
|---|
| A/Vietnam/1194/2004 | | | Title | Measurements |
|---|
| - OG0005.6(5.3 to 5.9)
- OG0015.5(5.2 to 5.8)
- OG0025.6(5.2 to 5.9)
- OG003
|
|
| |
| Primary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | 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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Within 21 days following 2-dose primary vaccination (at Day 42) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group - Lot 1 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Adjuvanted Group - Lot 2 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
|
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Within 21 days following the first primary vaccination dose (Day 21) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group - Lot 1 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Adjuvanted Group - Lot 2 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
|
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 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) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
|
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 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) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
|
| Secondary | Titers for Serum Neutralizing (SN) Antibodies Against 2 Strains of Influenza Disease | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Before vaccination at Day 0 (D0) and within 21 days following 2-dose primary vaccination at Day 42 (D42) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group - Lot 1 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Adjuvanted Group - Lot 2 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
|
| Secondary | Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 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) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
|
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0, at Day 21, at Day 42, at Month 6 and at Month 12 | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
| |
| Secondary | Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
| |
| Secondary | Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease | 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). | 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. | Posted | | Count of Participants | | Participants | | At Day 21 (D21) and at Day 42 (D42) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group - Lot 1 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Adjuvanted Group - Lot 2 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
|
| Secondary | Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease | 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). | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | |
|
| Secondary | Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase | 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). | 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. | Posted | | Count of Participants | | Participants | | Following booster vaccination at Month 6 +21 days (M6+21D) and Month 6 +42 days (M6+42D) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | |
|
| Secondary | Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase | 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). | 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. | Posted | | Count of Participants | | Participants | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
|
| Secondary | Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease | 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). | 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. | Posted | | Count of Participants | | Participants | | Within 21 days following 2-dose primary vaccination at Day 42 | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group - Lot 1 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Adjuvanted Group - Lot 2 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
|
| Secondary | Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease - Booster Phase | 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. | 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. | Posted | | Count of Participants | | Participants | | Following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
|
| Secondary | Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6 | 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. | 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. | Posted | | Count of Participants | | Participants | | At Day 21, Day 42, Month 6 and Month 12 following primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
| |
| Secondary | Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 | 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. | 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. | Posted | | Count of Participants | | Participants | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
| |
| Secondary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | 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). | 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. | Posted | | Number | 95% Confidence Interval | Fold change | | At day 21 and Day 42 | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group - Lot 1 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Adjuvanted Group - Lot 2 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
|
| Secondary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | 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). | 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. | Posted | | Number | 95% Confidence Interval | Fold change | | 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) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | |
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| Secondary | Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | 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). | 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. | Posted | | Number | 95% Confidence Interval | Fold change | | 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) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
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| Secondary | Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | 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). | 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. | Posted | | Number | 95% Confidence Interval | Fold change | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
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| Secondary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 | 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). | 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. | Posted | | Number | 95% Confidence Interval | Fold change | | At Day 21, at Day 42, at Month 6 and at Month 12 | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
| |
| Secondary | Number of Subjects Seroprotected Against 2 Strains of Influenza Disease | 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). | 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. | Posted | | Count of Participants | | Participants | | Before primary vaccination at Day 0 and within 21 days following each primary vaccination dose at Day 21 and at Day 42. | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group - Lot 1 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Adjuvanted Group - Lot 2 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
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| Secondary | Number of Subjects Seroprotected Against 2 Strains of Influenza Disease | 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). | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
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| Secondary | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | 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). | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
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| Secondary | Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 | 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). | 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. | Posted | | Count of Participants | | Participants | | At Day 0, Day 21, Day 42, Month 6 and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
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| Secondary | Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation | 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. | 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. | Posted | | Mean | Standard Deviation | T-cells per million T-cells | | Within 21 days of each primary vaccine dose: at Day 21 and at Day 42 | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group - Lot 1 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Adjuvanted Group - Lot 2 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
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| Secondary | Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation | 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. | 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. | Posted | | Mean | Standard Deviation | T-cells per million cells | | Within 21 days of each primary vaccine dose: at Day 21 and at Day 42 | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group - Lot 1 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Adjuvanted Group - Lot 2 | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
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| Secondary | Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation | 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. | 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. | Posted | | Mean | Standard Deviation | T-cells per million T-cells | | 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) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
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| Secondary | Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation | 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. | 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. | Posted | | Mean | Standard Deviation | T-cells per million T-cells | | 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) | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
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| Secondary | Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 | 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. | 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. | Posted | | Mean | Standard Deviation | T-cells per million T-cells | | At Month 6 and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
| |
| Secondary | Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 | 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. | 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. | Posted | | Mean | Standard Deviation | T-cells per million T-cells | | At Month 6 and at Month 12 | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | 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. | The analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects who had completed their symptom sheet for the considered timepoint. | Posted | | Count of Participants | | Participants | | During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | 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. | The analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects who had completed their symptom sheet for the considered timepoint. | Posted | | Count of Participants | | Participants | | During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase | 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. | 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. | Posted | | Count of Participants | | Participants | | During the 7-days (Days 0-6) post-booster vaccination period | | | | ID | Title | Description |
|---|
| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | |
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase | 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. | 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. | Posted | | Count of Participants | | Participants | | During the 7-days (Days 0-6) post-booster vaccination period | | | | ID | Title | Description |
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| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group |
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| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 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. | The analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available for the considered timepoint. | Posted | | Count of Participants | | Participants | | During the primary phase (from Day 0 to Month 6) | | | | ID | Title | Description |
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| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
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| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 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. | 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. | Posted | | Count of Participants | | Participants | | During the booster phase (from Month 6 to Month 12) | | | | ID | Title | Description |
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| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs). | 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. | The analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom were available for the considered timepoint. | Posted | | Count of Participants | | Participants | | During the primary phase (from Day 0 to Month 6) | | | | ID | Title | Description |
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| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs). | 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. | 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. | Posted | | Count of Participants | | Participants | | During the booster phase (from Month 6 to Month 12) | | | | ID | Title | Description |
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| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | | OG001 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) for Subjects Not Boosted at Month 6 | 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. | 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. | Posted | | Count of Participants | | Participants | | From Month 6 to Month 12 | | | | ID | Title | Description |
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| OG000 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
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