| Primary | Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value | The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG002 | GSK1562902A 2V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG003 | GSK1562902A 2V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
| | Units | Counts |
|---|
| Participants | - OG00056
- OG00155
- OG00250
- OG003
|
| | Title | Denominators | Categories |
|---|
| A/Indonesia, Day 0 | | |
| |
| Primary | Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value | The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 6 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | |
|
| Primary | Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value | The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 6 + 7 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | |
|
| Primary | Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value | The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 6 + 21 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | |
|
| Primary | Geometric Mean Titers (GMTs) of H5N1 HI Antibodies | GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG002 | GSK1562902A 2V/I/6 Group | |
|
| Primary | Geometric Mean Titers (GMTs) of H5N1 HI Antibodies | GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 6 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG002 | GSK1562902A 2V/I/6 Group | |
|
| Primary | Geometric Mean Titers (GMTs) of H5N1 HI Antibodies | GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 6 + 7 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG002 | GSK1562902A 2V/I/6 Group | |
|
| Primary | Geometric Mean Titers (GMTs) of H5N1 HI Antibodies | GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 6 + 21 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG002 | GSK1562902A 2V/I/6 Group | |
|
| Primary | Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | The seroconversion factor (SCF) was defined as the fold change in serum H5N1 HI geometric mean titers (GMTs) post-vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Geometric Mean | 95% Confidence Interval | Fold Increase | | At Month 6 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | |
|
| Primary | Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | The seroconversion factor (SCF) was defined as the fold change in serum H5N1 HI geometric mean titers (GMTs) post-vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Geometric Mean | 95% Confidence Interval | Fold Increase | | At Month 6 + 7 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
|
| Primary | Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | The seroconversion factor (SCF) was defined as the fold change in serum H5N1 HI geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Geometric Mean | 95% Confidence Interval | Fold Increase | | At Month 6 + 21 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Subjects received 1 dose of vaccine formulated from VT strain at Day 0 and 1 dose of the vaccine including IN at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG002 | GSK1562902A 2V/I/6 Group | |
|
| Primary | Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 6 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
|
| Primary | Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 6 + 7 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
|
| Primary | Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 6 + 21 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
|
| Primary | Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG002 |
|
| Primary | Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 6 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG002 |
|
| Primary | Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 6 + 7 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG002 |
|
| Primary | Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 6 + 21 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG002 |
|
| Primary | 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 = spreading beyond 100 millimeters (mm) of injection site. | This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in. The data for Dose 3 were not collected from subjects who did not receive the booster dose, given at either Month 6 or Month 12. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, up to 6/12 months + 7 days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
|
| Primary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature above (>) 38 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 > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in. The data for Dose 3 were not collected from subjects who did not receive the booster dose, given at either Month 6 or Month 12. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, up to 12 months + 7 days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
|
| Primary | Number of Subjects With Any, Grade 3 and Related 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | During the 30-day (Days 0-29) post-primary vaccination period (Month 6 + 30 days) | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Primary | Number of Subjects With Any, Grade 3 and Related 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available. Data were collected only for subjects who received the Month 12 vaccine dose. | Posted | | Count of Participants | | Participants | | During the 30-day (Days 0-29) post-booster vaccination period (Month 12 + 30 days) | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | |
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| Primary | Number of Subjects With Any, Grade 3 and Related 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | This analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | During the entire study period (Day 0 to Month 18) | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Primary | 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. | This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | During the entire study period (Day 0 to Month 18) | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG002 | GSK1562902A 2V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6.The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Primary | Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease | Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 6), antibody titer ≥ 1:40 at Month 6 + 7 days; For seropositive subjects at pre-booster (Month 6), antibody titer at Month 6 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 6. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 6 + 7 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Primary | Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease | Booster SCR was defined as: For seronegative subjects at pre-booster (Month 6), antibody titer ≥ 1:40 at Month 6 + 7 days; For seropositive subjects at pre-booster (Month 6), antibody titer at Month 6 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 6. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 6 + 21 days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Primary | Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease | Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean[log10(POST/M6)]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Geometric Mean | 95% Confidence Interval | Fold Increase | | At Month 6 + 7 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Primary | Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease | Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean[log10(POST/M6)]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 6. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Geometric Mean | 95% Confidence Interval | Fold Increase | | At Month 6 + 21 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12 | GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains. | This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for Month 18), which included all evaluable subjects for whom immunogenicity were available and who complied with the inclusion/exclusion criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and at Month 18 | | | | ID | Title | Description |
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| OG000 | GSK1562902A V/I/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 | A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005. | This analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses. | Posted | | Count of Participants | | Participants | | At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 | Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; 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 and A/Indonesia/05/2005. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Persistence, which included all evaluable subjects for whom ilong term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 12 + 7 Days, Month 12 + 21 Days and Month 18 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12 | The seroconversion factor (SCF) was defined as the fold change 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 and A/Indonesia/5/2005. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses. | Posted | | Geometric Mean | 95% Confidence Interval | Fold Increase | | At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12 | 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). | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses. | Posted | | Count of Participants | | Participants | | At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6 | GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0, Day 21, Day 42, Month 6, Month 6+ 7 Days, Month 6+ 21 Days, Month 12 and at Month 18 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG002 |
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| Secondary | Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 | A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). | This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M6+D7/D21, M18), which included all evaluable subjects for whom immunogenicity data were available and who complied with the criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses. | Posted | | Count of Participants | | Participants | | At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6 | The seroconversion factor (SCF) was defined as the fold change 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). | This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M6+D7/D21, M18), which included all evaluable subjects for whom immunogenicity data were available and who complied with the criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses. | Posted | | Geometric Mean | 95% Confidence Interval | Fold Increase | | At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 | A seroprotected (SPR) 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). | This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M18), which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses. | Posted | | Count of Participants | | Participants | | At Day 0, Day 21, Day 42, Month 6, Month 6+ 7 Days, Month 6+ 21 Days, Month 12 and Month 18 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, A/Vietnam/1194/2004 and A/Indonesia/5/2005, for Groups Who Received Booster Dose at Month 12 | Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 12), antibody titer ≥ 1:40 at Month 12 + 7 days; For seropositive subjects at pre-booster (Month 12), antibody titer at Month 12 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 12. | This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M18), which included all evaluable subjects for whom immunogenicity data/long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 12 + 7 Days, Month 12 + 21 Days and Month 18 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 | Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean[log10(POST/M12)]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 12. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Geometric Mean | 95% Confidence Interval | Fold Increase | | At Month 12 + 7 Days and at Month 12 + 21 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 | Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean[log10(POST/M12)]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 12. | The analysis was performed on the ATP Cohort for persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Geometric Mean | 95% Confidence Interval | Fold Increase | | At Month 12 + 7 Days, Month 12 + 21 Days and at Month 18 | | | | ID | Title | Description |
|---|
| OG000 | GSK1562902A V/I/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6 | Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 All Doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The 2 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M12, M18), which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Mean | Standard Deviation | cells/million T-cells | | At Day 0, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18 | | | | ID | Title | Description |
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| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12 | Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 All Doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The 2 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Mean | Standard Deviation | cells/million T-cells | | At Day 0, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and Month 18 | | | | ID | Title | Description |
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| OG000 | GSK1562902A V/I/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6 | GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0, Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days and Month 12 | | | | ID | Title | Description |
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| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | |
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| Secondary | GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12 | GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days and Month 12 + 21 Days | | | | ID | Title | Description |
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| OG000 | GSK1562902A V/I/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 | GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains. | The analysis was performed on the ATP Cohort for Persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0, Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18 | | | | ID | Title | Description |
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| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | |
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| Secondary | GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 | GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains. | The analysis was performed on the ATP Cohort for Persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and Month 18 | | | | ID | Title | Description |
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| OG000 | GSK1562902A V/I/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | |
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| Secondary | Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 | Seroconversion (SCR) was defined as the percentage of vaccinees with a minimum 4-fold increase in neutralizing antibody titer at the post-vaccination time-point compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses. | Posted | | Count of Participants | | Participants | | At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days and Month 12 | | | | ID | Title | Description |
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| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 | Seroconversion (SCR) was defined as the percentage of vaccinees with a minimum 4-fold increase in neutralizing antibody titer at the post-vaccination time-point compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses. | Posted | | Count of Participants | | Participants | | At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days and Month 12 + 21 Days | | | | ID | Title | Description |
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| OG000 | GSK1562902A V/I/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 | Booster SCR was defined as: For seronegative subjects at pre-booster (Month 6), antibody titer ≥ 1:40 at Month 6 + 7 days; For seropositive subjects at pre-booster (Month 6), antibody titer at Month 6 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 6. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005. | This analysis was performed on the ATP Cohort for Immunogenicity (only for M12) and ATP Cohort for Persistence, which included all evaluable subjects for whom immunogenicity data/long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18 | | | | ID | Title | Description |
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| OG000 | GSK1562902A V/I/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/6 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 | Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 12), antibody titer ≥ 1:40 at Month 12 + 7 days; For seropositive subjects at pre-booster (Month 12), antibody titer at Month 12 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 12. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005. | This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 12 + 7 Days and Month 12 + 21 Days | | | | ID | Title | Description |
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| OG000 | GSK1562902A V/I/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. |
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| Secondary | Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 | Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 12), antibody titer ≥ 1:40 at Month 12 + 7 days; For seropositive subjects at pre-booster (Month 12), antibody titer at Month 12 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 12. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005. | The analysis was performed on the ATP Cohort for Persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. | Posted | | Count of Participants | | Participants | | At Month 12 + 7 Days, Month 12 + 21 Days and Month 18 | | | | ID | Title | Description |
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| OG000 | GSK1562902A V/I/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. | | OG001 | GSK1562902A V/V/12 Group | Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm. |
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