Vaccines, Pneumococcal Conjugate Vaccine
Conditions
Brief summary
This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) when administered to subjects who have already received one dose of 13vPnC, and one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) one year later. This study will determine if a subsequent dose of 13vPnC one year later results in similar or greater immune response (body's ability to protect against disease) than that measured after the initial dose of 13vPnC.
Interventions
BIOLOGICAL13-valent Pneumococcal Conjugate Vaccine
1 dose 13vPnC
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Previous participant of study 6115A1-500 and received 13vPnC +AlPO4 / 23vPS * Generally healthy male or female adults 65 years of age or older * Available for the duration of the trial - approximately 1 month * No history of severe adverse reaction associated with a vaccine * MMSE score less than or equal to 21 was an
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357) | Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357) | Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. |
| Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357) | Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
| Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357) | Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Days 1 through 14 / Year 2 (Follow-up study/NCT00500357) | Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\> 10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move shoulder). |
| Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Days 1 through 14 / Year 2 (Follow-up study/NCT00500357) | Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \[C\]); Mild (≥38 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Aggravated muscle pain, New joint pain, and Aggravated joint pain. |
Countries
South Africa
Participant flow
Recruitment details
915 participants were enrolled in core study NCT00269672 (6115A1-500); 914 participants received 13-valent pneumococcal conjugate vaccine plus or minus aluminum phosphate (13vPnC+AlPO4 or 13vPnC-AlPO4) or 23-valent pneumococcal polysaccharide vaccine (23vPS) in Year 0 (Vaccination 1 \[Vax 1\]) followed by 13vPnC+AlPO4 or 23vPS in Year 1 (Vax 2).
Pre-assignment details
105 participants from the core study NCT00269672 (6115A1-500) who had received 13vPnC+AlPO4 (13vPnC) followed by 23vPS enrolled in the follow-up study NCT00500357 (6115A1-3009) 1 year after completion of the core study and received a subsequent 13vPnC dose at Year 2 (Vax 3).
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC (Vax 3 Follow-up / NCT00500357) Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009). | 105 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | 13vPnC (Vax 3 Follow-up / NCT00500357) |
|---|---|
| Age Continuous | 72.8 years STANDARD_DEVIATION 4.9 |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 46 / 105 | 70 / 308 | 58 / 304 | 80 / 302 | 26 / 139 | 35 / 128 | 76 / 273 |
| serious Total, serious adverse events | 2 / 105 | 2 / 308 | 4 / 304 | 1 / 302 | 3 / 139 | 1 / 128 | 1 / 273 |
Outcome results
Primary
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time frame: Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)
Population: Evaluable Immunogenicity population includes participants from the evaluable immunogenicity population for Vax 1 and Vax 2 in the core study/NCT00269672, received 13vPnC in follow-up study/NCT00500357, and had at least 1 assay result in the follow-up study. N=number of participants with a determinate antibody titer for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 4 | 2210 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 7F | 869 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 18C | 2860 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 9V | 977 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 5 | 413 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 14 | 982 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 3 | 126 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 19A | 1141 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 6A | 4931 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 19F | 1014 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 1 | 198 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 23F | 523 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 6B | 3251 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 23F | 661 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 1 | 78 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 3 | 104 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 4 | 1254 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 5 | 170 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 6A | 3158 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 6B | 2440 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 7F | 353 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 9V | 247 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 18C | 1457 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 19A | 431 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 19F | 494 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 14 | 550 geometric mean titer |
Comparison: Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.28, 0.56]
Comparison: Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.67, 1.01]
Comparison: Serotype 4: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.44, 0.72]
Comparison: Serotype 5: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.32, 0.53]
Comparison: Serotype 6A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.45, 0.91]
Comparison: Serotype 6B: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.56, 1.01]
Comparison: Serotype 7F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.25, 0.65]
Comparison: Serotype 9V: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.16, 0.4]
Comparison: Serotype 14: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.4, 0.78]
Comparison: Serotype 18C: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.4, 0.65]
Comparison: Serotype 19A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.3, 0.48]
Comparison: Serotype 19F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.35, 0.67]
Comparison: Serotype 23F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.86, 1.86]
Secondary
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time frame: Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)
Population: Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 7F | 7.41 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 1 | 7.29 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 9V | 9.60 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 5 | 9.29 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 14 | 22.67 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 19A | 22.78 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 18C | 11.66 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 6A | 5.51 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 3 | 2.46 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 19F | 15.82 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 6B | 9.67 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 23F | 7.27 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 4 | 3.93 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 23F | 7.73 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 1 | 4.99 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 4 | 2.96 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 5 | 6.33 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 6A | 8.22 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 6B | 10.32 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 7F | 5.02 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 9V | 5.77 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 14 | 13.34 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 18C | 7.82 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 19A | 17.80 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 19F | 8.55 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 3 | 1.36 geometric mean concentration (mcg/mL) |
Comparison: Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.6, 0.78]
Comparison: Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.48, 0.64]
Comparison: Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.65, 0.87]
Comparison: Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.61, 0.76]
Comparison: Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [1.27, 1.75]
Comparison: Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.94, 1.21]
Comparison: Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.58, 0.79]
Comparison: Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.53, 0.68]
Comparison: Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.51, 0.67]
Comparison: Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.6, 0.74]
Comparison: Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.69, 0.88]
Comparison: Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.47, 0.62]
Comparison: Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.9, 1.25]
Secondary
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time frame: Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)
Population: Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 7F | 6.93 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 1 | 7.67 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 5 | 19.51 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 14 | 17.51 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 3 | 2.60 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 18C | 20.59 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 6A | 9.12 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 19A | 29.52 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 9V | 11.56 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 19F | 13.39 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 6B | 13.03 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 23F | 10.16 geometric mean concentration (mcg/mL) |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 4 | 4.68 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 23F | 7.73 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 3 | 1.35 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 4 | 2.96 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 5 | 6.33 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 6A | 8.22 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 6B | 10.32 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 7F | 5.02 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 9V | 5.77 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 14 | 13.34 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 18C | 7.82 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 19A | 17.80 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 19F | 8.55 geometric mean concentration (mcg/mL) |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) | Serotype 1 | 4.99 geometric mean concentration (mcg/mL) |
Comparison: Serotype 1: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.52, 0.82]
Comparison: Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.43, 0.62]
Comparison: Serotype 4: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.53, 0.76]
Comparison: Serotype 5: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.27, 0.39]
Comparison: Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.74, 1.1]
Comparison: Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.63, 0.99]
Comparison: Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.6, 0.87]
Comparison: Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.42, 0.6]
Comparison: Serotype 14: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.59, 0.98]
Comparison: Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.31, 0.46]
Comparison: Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.49, 0.74]
Comparison: Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.52, 0.79]
Comparison: Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.95% CI: [0.62, 0.93]
Secondary
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time frame: Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)
Population: Evaluable Immunogenicity population; N=number of participants with a determinate antibody titer for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 1 | 184 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 3 | 131 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 6A | 1732 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 18C | 1753 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 4 | 1457 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 5 | 326 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 6B | 1862 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 7F | 1292 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 9V | 624 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 14 | 808 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 19A | 756 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 19F | 901 geometric mean titer |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 23F | 484 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 19F | 527 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 1 | 81 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 7F | 351 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 5 | 219 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 19A | 511 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 9V | 267 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 3 | 104 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 23F | 731 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 4 | 1406 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 14 | 557 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 6A | 3443 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 18C | 1452 geometric mean titer |
| 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357) | Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) | Serotype 6B | 2505 geometric mean titer |
Comparison: Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.34, 0.57]
Comparison: Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.66, 0.95]
Comparison: Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.76, 1.22]
Comparison: Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.57, 0.8]
Comparison: Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [1.39, 2.84]
Comparison: Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [1.11, 1.63]
Comparison: Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.18, 0.41]
Comparison: Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.27, 0.68]
Comparison: Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.57, 0.83]
Comparison: Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.66, 1.03]
Comparison: Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.58, 0.78]
Comparison: Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [0.47, 0.73]
Comparison: Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.95% CI: [1.18, 1.94]
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\> 10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move shoulder).
Time frame: Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)
Population: Safety population included all participants who received the vaccine sequence 13vPnC / 23vPS / 13vPnC. N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Swelling: Any (n=83) | 16.9 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Swelling: Mild (n=81) | 12.3 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Redness: Any (n=79) | 7.6 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Redness: Mild (n=79) | 6.3 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Redness: Moderate (n=78) | 3.8 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Redness: Severe (n=78) | 0.0 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Swelling: Moderate (n=81) | 8.6 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Swelling: Severe (n=78) | 0.0 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Pain: Any (n=89) | 40.4 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Pain: Mild (n=88) | 34.1 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Pain: Moderate (n=83) | 15.7 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Pain: Severe (n=78) | 0.0 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Limitation of arm movement: Any (n=80) | 11.3 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Limitation of arm movement: Mild (n=80) | 8.8 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Limitation of arm movement: Moderate (n=78) | 2.6 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Limitation of arm movement: Severe (n=79) | 1.3 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \[C\]); Mild (≥38 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Aggravated muscle pain, New joint pain, and Aggravated joint pain.
Time frame: Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)
Population: Safety population; N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | New muscle pain (n=84) | 21.4 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Aggravated muscle pain (n=80) | 12.5 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Fever: Any ≥38 degrees C (n=81) | 7.4 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Fever: Mild ≥38 but <38.5 degrees C (n=80) | 3.8 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Fever: Moderate ≥38.5 but <39 degrees C (n=78) | 2.6 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Fever: Severe ≥39 but ≤40 degrees C (n=80) | 2.5 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Potentially life-threatening >40 degrees C (n=79) | 1.3 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Fatigue (n=83) | 27.7 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Headache (n=81) | 19.8 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Chills (n=79) | 8.9 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Rash (n=78) | 2.6 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Vomiting (n=79) | 1.3 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Decreased appetite (n=82) | 18.3 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | New joint pain (n=78) | 7.7 percentage of participants |
| 13vPnC (Vax 1 Core Study/NCT00269672) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) | Aggravated joint pain (n=79) | 6.3 percentage of participants |