| Primary | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. | All-Available Immunogenicity Population included all participants enrolled in 6115A1-3018 (NCT01025336) with a valid and determinate assay result who received both vaccinations in either parent study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572). N=number of participants with valid and determinate antibody titer for the specified serotype. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPs Naïve) | Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | | OG001 | 13vPnC/23vPS Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) | | OG002 | 23vPS/13vPnC Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
| | | Title | Denominators | Categories |
|---|
| Serotype 1 | | | Title | Measurements |
|---|
| - OG00054(40.8 to 71.0)
- OG00152(40.9 to 65.5)
- OG00236(27.1 to 46.7)
|
| | Serotype 3 |
| |
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 1/Year 1 (Parent study/NCT00574548), Month 1/Year 2 (Follow-up Study/NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | | OG001 | 13vPnC/23vPS Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 1/Year 1 (Parent study/NCT00546572), Month 1/Year 2 (Follow-up Study/NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)and at Year 1 (Vaccination 2) | | OG001 | 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 1 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | | OG001 | 13vPnC/23vPS Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | | OG001 | 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 1/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | | OG001 | 13vPnC/23vPS Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 1/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | | OG001 | 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | | OG001 | 13vPnC/23vPS Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | | OG001 | 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/23vPS Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) | | OG001 | 23vPS/13vPnC Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | | OG001 | 23vPS/13vPnC Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | | OG001 | 13vPnC/23vPS Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | | OG001 | 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/23vPS Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) | | OG001 | 23vPS (23vPS Naïve) | Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2). |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 23vPS/13vPnC Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) | | OG001 | 13vPnC (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and either 13vPnC or 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) (both 13vPnC/13vPnC and 13vPnC/23vPS dose groups) |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) |
| |
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Baseline; Follow-up Study NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) | | OG001 | 13vPnC (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) |
|
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 1 (Parent Study NCT00546572), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) |
| |
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 1 (Parent Study NCT00574548) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC (23vPS Naïve) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) | | OG001 | 23vPS (23vPS Naïve) | Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (6115A1-3010 NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) |
| |
| Secondary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0/Year 1 (Parent Study NCT00546572) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | | OG001 | 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
|
| Primary | Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. | All-Available Immunogenicity Population. N=number of participants with valid and determinate antibody titer for the specified serotype. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) | | | | ID | Title | Description |
|---|
| OG000 | 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | | OG001 | 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
|