Healthy
Conditions
Keywords
Vaccines, Pneumococcal Conjugate Vaccine
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate (13vPnC) vaccine in healthy Japanese adults aged \>= 50 years.
Interventions
BIOLOGICAL13vPnC
13vPnC for both stratum
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Japanese descent male and female adults who do not have the potential to bear children \>= 50 years of age. * Determined to be eligible for the study based on medical history, physical examination, and clinical judgment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of study vaccine, are eligible. * Sexually active men must agree and commit to use a medically accepted form of contraception during the study and for at least 3 months after vaccination.
Exclusion criteria
* History of severe adverse reaction associated with a vaccine. * Receipt of any vaccine within 30 days before study vaccination, except influenza vaccine. * Documented S pneumoniae infection within the past 5 years before study vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | 1 month after vaccination | Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% confidence intervals (CIs) on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. |
| Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | 1 month after vaccination | Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. |
| Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Prevaccination (Day 1), 1 month after vaccination | Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results. |
| Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Prevaccination (Day 1), 1 month after vaccination | Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | 1 month after vaccination | For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. |
| Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | 1 month after vaccination | For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. |
| Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | 1 month after vaccination | For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. |
| Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | 1 month after vaccination | For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. |
| Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | 1 month after vaccination | For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. |
| Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | 1 month after vaccination | For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. |
| Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | 1 month after vaccination | Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. |
| Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | 1 month after vaccination | Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. |
| Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | 1 month after vaccination | Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. |
| Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | 1 month after vaccination | Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. |
| Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | 1 month after vaccination | Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results. |
| Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | 1 month after vaccination | Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results. |
| Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Day 1 through 14 | 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 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 above shoulder). |
| Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Day 1 through 14 | 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 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 above shoulder). |
| Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Day 1 through 14 | Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius \[C\]); Mild (≥37.5 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain. |
| Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | Day 1 through 14 | Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius \[C\]); Mild (≥37.5 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain. |
| Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | 1 month after vaccination | For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion. |
| Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | 1 month after vaccination | For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion. |
| Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | 1 month after vaccination | For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion. |
Countries
Japan
Participant flow
Pre-assignment details
271 participants were enrolled; 270 were vaccinated with study vaccine.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC (50 to 64 Years of Age) 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age. | 134 |
| 13vPnC (≥65 Years of Age) 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age. | 134 |
| Total | 268 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | 13vPnC (50 to 64 Years of Age) | 13vPnC (≥65 Years of Age) | Total |
|---|---|---|---|
| Age Continuous | 57.5 years STANDARD_DEVIATION 4 | 70.5 years STANDARD_DEVIATION 4.4 | 64.0 years STANDARD_DEVIATION 7.7 |
| Sex: Female, Male Female | 76 Participants | 70 Participants | 146 Participants |
| Sex: Female, Male Male | 58 Participants | 64 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 120 / 134 | 118 / 136 |
| serious Total, serious adverse events | 1 / 134 | 1 / 136 |
Outcome results
Primary
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Time frame: Prevaccination (Day 1), 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 7F | 99.9 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 18C | 31.0 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19A | 25.3 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 14 | 10.6 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19F | 25.3 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 23F | 40.8 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 1 | 18.7 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 3 | 9.8 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 4 | 50.7 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 5 | 34.3 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6A | 32.3 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6B | 11.2 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 9V | 7.3 fold rise |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6A | 74.7 fold rise |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 1 | 28.8 fold rise |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 5 | 52.0 fold rise |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 7F | 192.5 fold rise |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 9V | 24.2 fold rise |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 3 | 13.6 fold rise |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 14 | 14.6 fold rise |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 18C | 89.2 fold rise |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19A | 69.5 fold rise |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6B | 24.1 fold rise |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19F | 70.3 fold rise |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 4 | 123.3 fold rise |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 23F | 54.7 fold rise |
Primary
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Time frame: Prevaccination (Day 1), 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Serotype 1 | 23.3 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Serotype 3 | 11.5 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Serotype 4 | 79.6 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Serotype 5 | 42.4 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Serotype 6A | 48.8 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Serotype 6B | 16.6 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Serotype 7F | 137.2 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Serotype 9V | 13.4 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Serotype 14 | 12.4 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Serotype 18C | 52.9 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Serotype 19A | 41.9 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Serotype 19F | 42.7 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population | Serotype 23F | 47.5 fold rise |
Primary
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 3 | 53 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 18C | 1503 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 4 | 1209 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19F | 614 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 5 | 159 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 23F | 361 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6A | 1667 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 14 | 1294 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6B | 2556 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 7F | 1469 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 1 | 93 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 9V | 738 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19A | 616 titer |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 9V | 1007 titer |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19F | 1083 titer |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 14 | 1726 titer |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 18C | 2862 titer |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19A | 1241 titer |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 23F | 788 titer |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 1 | 162 titer |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 3 | 73 titer |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 4 | 1464 titer |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 5 | 289 titer |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6A | 3082 titer |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 7F | 2218 titer |
| 13vPnC (≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6B | 3182 titer |
Primary
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population
Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% confidence intervals (CIs) on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 6B | 2861 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 7F | 1793 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 9V | 863 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 18C | 2082 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 1 | 124 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 3 | 62 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 4 | 1333 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 5 | 215 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 6A | 2256 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 14 | 1494 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 19A | 874 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 19F | 821 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 23F | 538 titer |
Secondary
Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group
For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 9V | 52.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 14 | 62.4 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 18C | 80.3 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19A | 92.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19F | 86.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 23F | 80.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 1 | 86.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 3 | 81.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 4 | 79.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 5 | 84.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6A | 82.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6B | 61.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 7F | 82.5 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6A | 87.1 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 3 | 87.1 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 14 | 72.0 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 7F | 89.8 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 18C | 90.8 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 4 | 90.4 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19A | 91.9 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6B | 74.6 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19F | 89.8 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 5 | 89.4 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 23F | 82.5 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 9V | 70.0 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 1 | 93.2 percentage of participants |
Comparison: Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-15.1, 0.3]
Comparison: Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-14.5, 3.5]
Comparison: Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-21.4, -1]
Comparison: Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-13.5, 3.9]
Comparison: Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-14.3, 4]
Comparison: Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-24.6, -0.8]
Comparison: Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-16.3, 1.5]
Comparison: Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-29.5, -5]
Comparison: Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-21.4, 2.4]
Comparison: Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-19.3, -1.3]
Comparison: Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-6.2, 7.9]
Comparison: Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-12.2, 4.5]
Comparison: Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-12.5, 7.3]
Secondary
Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group
For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 4 | 65.3 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 9V | 36.4 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6A | 69.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 14 | 52.8 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 3 | 73.3 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 18C | 70.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6B | 51.3 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19A | 85.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 5 | 83.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19F | 73.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 7F | 77.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 23F | 71.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 1 | 86.0 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 23F | 79.4 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 1 | 91.7 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 3 | 78.8 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 4 | 83.7 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 5 | 86.2 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6A | 81.5 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6B | 62.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 7F | 86.4 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 9V | 63.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 14 | 59.2 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 18C | 83.1 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19A | 86.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19F | 84.4 percentage of participants |
Comparison: Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-13.8, 2.1]
Comparison: Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-15.9, 5]
Comparison: Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-30.1, -5.9]
Comparison: Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-11.6, 6.9]
Comparison: Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-22.6, -1.2]
Comparison: Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-23.8, 1.9]
Comparison: Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-19.3, 0.4]
Comparison: Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-39, -14.1]
Comparison: Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-18.7, 6.1]
Comparison: Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-22.6, -1.7]
Comparison: Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-9.8, 8.1]
Comparison: Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-21.7, -1.2]
Comparison: Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-18.5, 3.4]
Secondary
Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group
For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 4 | 93.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 14 | 98.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6A | 97.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 18C | 95.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 3 | 87.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19A | 99.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6B | 97.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 5 | 85.8 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19F | 93.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 23F | 86.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 7F | 93.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 9V | 88.6 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 1 | 89.1 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 7F | 99.2 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 1 | 94.0 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 4 | 96.9 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 5 | 91.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6A | 99.2 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6B | 99.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 9V | 89.5 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 14 | 98.5 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 18C | 97.7 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19A | 98.5 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19F | 95.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 23F | 92.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 3 | 91.8 percentage of participants |
Comparison: Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-12.1, 2]
Comparison: Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-11.6, 3.5]
Comparison: Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-9.6, 2.2]
Comparison: Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-13.7, 2.5]
Comparison: Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-5.7, 2.1]
Comparison: Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-5.9, 2.1]
Comparison: Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-10.8, -0.9]
Comparison: Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-8.7, 6.9]
Comparison: Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-4, 4.1]
Comparison: Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-7.6, 2.5]
Comparison: Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-2.8, 4.7]
Comparison: Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-8.8, 3.7]
Comparison: Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).95% CI: [-14.1, 1.5]
Secondary
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group
Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with determinate antibody concentration for the specified serotype. GMCs calculated using all participants with available data for the specified blood draw.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 4 | 3.53 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 9V | 6.55 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6A | 6.72 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 14 | 16.73 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 3 | 1.35 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 18C | 10.47 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6B | 6.71 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19A | 13.51 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 5 | 6.74 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19F | 4.69 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 7F | 8.90 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 23F | 9.38 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 1 | 4.65 mcg/mL |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 23F | 15.93 mcg/mL |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 1 | 7.69 mcg/mL |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 3 | 1.69 mcg/mL |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 4 | 5.35 mcg/mL |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 5 | 10.32 mcg/mL |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6A | 9.45 mcg/mL |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6B | 10.28 mcg/mL |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 7F | 12.09 mcg/mL |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 9V | 14.22 mcg/mL |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 14 | 22.13 mcg/mL |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 18C | 18.48 mcg/mL |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19A | 27.09 mcg/mL |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19F | 11.21 mcg/mL |
Comparison: Serotype 1: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.43, 0.86]
Comparison: Serotype 3: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.63, 1]
Comparison: Serotype 4: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.48, 0.91]
Comparison: Serotype 5: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.5, 0.85]
Comparison: Serotype 6A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.52, 0.97]
Comparison: Serotype 6B: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.48, 0.9]
Comparison: Serotype 7F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.56, 0.97]
Comparison: Serotype 9V: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.35, 0.61]
Comparison: Serotype 14: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.56, 1.03]
Comparison: Serotype 18C: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.43, 0.74]
Comparison: Serotype 19A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.38, 0.66]
Comparison: Serotype 19F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.29, 0.6]
Comparison: Serotype 23F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.42, 0.82]
Secondary
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group
Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with determinate antibody titers for the specified serotype. GMTs calculated using all participants with available data for the specified blood draw.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19F | 627 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 4 | 1331 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 5 | 171 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6A | 1663 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6B | 2462 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 7F | 1484 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 9V | 797 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19A | 604 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 23F | 398 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 1 | 93 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 3 | 54 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 14 | 1289 titer |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 18C | 1530 titer |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19A | 1267 titer |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 14 | 1740 titer |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 4 | 1786 titer |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 23F | 824 titer |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 5 | 294 titer |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 19F | 1094 titer |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6A | 3148 titer |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 3 | 73 titer |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 6B | 3383 titer |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 1 | 164 titer |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 7F | 2247 titer |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 18C | 2922 titer |
| 13vPnC (≥65 Years of Age) | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group | Serotype 9V | 1062 titer |
Comparison: Serotype 1: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.39, 0.84]
Comparison: Serotype 3: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.54, 1.01]
Comparison: Serotype 4: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.5, 1.11]
Comparison: Serotype 5: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.38, 0.9]
Comparison: Serotype 6A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.37, 0.74]
Comparison: Serotype 6B: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.52, 1.02]
Comparison: Serotype 7F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.46, 0.95]
Comparison: Serotype 9V: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.45, 1.25]
Comparison: Serotype 14: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.54, 1.02]
Comparison: Serotype 18C: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.35, 0.79]
Comparison: Serotype 19A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.34, 0.67]
Comparison: Serotype 19F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.37, 0.88]
Comparison: Serotype 23F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.95% CI: [0.3, 0.79]
Secondary
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 4 | 11.33 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 9V | 5.76 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6A | 3.32 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 14 | 5.93 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 3 | 2.40 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 18C | 9.92 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6B | 3.26 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19A | 5.12 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 5 | 3.23 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19F | 3.80 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 7F | 9.10 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 23F | 6.26 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 1 | 8.86 fold rise |
| 13vPnC (≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 23F | 9.71 fold rise |
| 13vPnC (≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 1 | 14.77 fold rise |
| 13vPnC (≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 3 | 3.47 fold rise |
| 13vPnC (≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 4 | 22.44 fold rise |
| 13vPnC (≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 5 | 5.34 fold rise |
| 13vPnC (≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6A | 5.39 fold rise |
| 13vPnC (≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6B | 5.71 fold rise |
| 13vPnC (≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 7F | 14.88 fold rise |
| 13vPnC (≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 9V | 12.80 fold rise |
| 13vPnC (≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 14 | 7.80 fold rise |
| 13vPnC (≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 18C | 16.96 fold rise |
| 13vPnC (≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19A | 10.57 fold rise |
| 13vPnC (≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19F | 9.43 fold rise |
Secondary
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 1 | 11.38 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 3 | 2.89 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 4 | 15.89 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 5 | 4.15 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 6A | 4.23 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 6B | 4.32 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 7F | 11.59 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 9V | 8.56 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 14 | 6.79 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 18C | 12.94 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 19A | 7.36 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 19F | 6.03 fold rise |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 23F | 7.80 fold rise |
Secondary
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19A | 92.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19F | 86.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 23F | 80.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 1 | 86.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 3 | 81.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 4 | 79.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 5 | 84.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6A | 82.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6B | 61.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 7F | 82.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 9V | 52.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 14 | 62.4 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 18C | 80.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 9V | 70.0 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19A | 91.9 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6A | 87.1 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19F | 89.8 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 18C | 90.8 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 23F | 82.5 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6B | 74.6 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 1 | 93.2 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 14 | 72.0 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 3 | 87.1 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 7F | 89.8 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 4 | 90.4 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 5 | 89.4 percentage of participants |
Secondary
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population
For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 23F | 81.3 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 1 | 89.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 3 | 84.4 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 4 | 84.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 5 | 87.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 6A | 84.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 6B | 68.4 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 7F | 86.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 9V | 61.3 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 14 | 67.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 18C | 85.6 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 19A | 92.3 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 19F | 88.0 percentage of participants |
Secondary
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 4 | 65.3 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 9V | 36.4 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6A | 69.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 14 | 52.8 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 3 | 73.3 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 18C | 70.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6B | 51.3 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19A | 85.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 5 | 83.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19F | 73.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 7F | 77.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 23F | 71.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 1 | 86.0 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 23F | 79.4 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 1 | 91.7 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 3 | 78.8 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 4 | 83.7 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 5 | 86.2 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6A | 81.5 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6B | 62.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 7F | 86.4 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 9V | 63.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 14 | 59.2 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 18C | 83.1 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19A | 86.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19F | 84.4 percentage of participants |
Secondary
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population
For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 6B | 57.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 7F | 81.6 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 1 | 88.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 3 | 76.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 4 | 74.6 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 5 | 85.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 6A | 75.4 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 9V | 50.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 14 | 56.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 18C | 77.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 19A | 85.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 19F | 78.8 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 23F | 75.6 percentage of participants |
Secondary
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 7F | 93.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 3 | 87.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 9V | 88.6 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 14 | 98.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 18C | 95.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19A | 99.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19F | 93.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 23F | 86.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 4 | 93.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 5 | 85.8 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6A | 97.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6B | 97.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 1 | 89.1 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6A | 99.2 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 1 | 94.0 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19F | 95.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 3 | 91.8 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 7F | 99.2 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 5 | 91.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 9V | 89.5 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 23F | 92.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 14 | 98.5 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6B | 99.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 18C | 97.7 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 4 | 96.9 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19A | 98.5 percentage of participants |
Secondary
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population
For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 1 | 91.6 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 3 | 89.8 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 4 | 95.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 5 | 88.6 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 9V | 89.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 6A | 98.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 6B | 98.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 7F | 96.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 14 | 98.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 18C | 96.6 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 19A | 98.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 19F | 94.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 23F | 89.2 percentage of participants |
Secondary
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
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 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 above shoulder).
Time frame: Day 1 through 14
Population: Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Redness: mild | 7.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Swelling: severe | 0.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Pain: any | 52.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Redness: severe | 0.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Pain: moderate | 8.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Redness: moderate | 1.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Pain: severe | 1.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Pain: mild | 49.6 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Limitation of arm movement: any | 53.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Redness: any | 7.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Limitation of arm movement: mild | 51.8 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Swelling: mild | 7.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Limitation of arm movement: moderate | 5.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Swelling: any | 8.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Limitation of arm movement: severe | 2.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Swelling: moderate | 2.0 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Limitation of arm movement: severe | 0.9 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Redness: mild | 10.0 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Redness: moderate | 16.7 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Redness: severe | 0.9 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Swelling: any | 14.7 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Swelling: severe | 0.9 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Pain: any | 44.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Swelling: mild | 7.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Swelling: moderate | 9.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Pain: mild | 42.6 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Pain: moderate | 10.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Pain: severe | 0.0 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Limitation of arm movement: any | 53.4 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Limitation of arm movement: mild | 52.5 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Limitation of arm movement: moderate | 3.7 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Redness: any | 20.9 percentage of participants |
Secondary
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population
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 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 above shoulder).
Time frame: Day 1 through 14
Population: Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Limitation of arm movement: any | 53.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Limitation of arm movement: mild | 52.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Limitation of arm movement: moderate | 4.4 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Limitation of arm movement: severe | 1.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Redness: any | 14.4 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Redness: mild | 8.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Redness: moderate | 9.3 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Redness: severe | 0.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Swelling: any | 11.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Swelling: mild | 7.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Swelling: moderate | 5.8 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Swelling: severe | 0.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Pain: any | 48.3 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Pain: mild | 46.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Pain: moderate | 9.6 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population | Pain: severe | 0.5 percentage of participants |
Secondary
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius \[C\]); Mild (≥37.5 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain.
Time frame: Day 1 through 14
Population: Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Fever: mild ≥37.5 but <38.5 degrees C | 2.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Vomiting | 3.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Headache | 26.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Decreased appetite | 16.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Fever any ≥37.5 degrees C | 3.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | New muscle pain | 34.3 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Chills | 14.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Any aggravated muscle pain | 11.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Fever: moderate ≥38.5 but <39 degrees C | 1.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | New joint pain | 10.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Rash | 8.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Any aggravated joint pain | 7.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Fatigue | 38.8 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Any aggravated joint pain | 5.5 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Fatigue | 24.1 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Fever any ≥37.5 degrees C | 3.7 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Fever: mild ≥37.5 but <38.5 degrees C | 3.7 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Fever: moderate ≥38.5 but <39 degrees C | 0.0 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Headache | 14.4 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Chills | 10.8 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Rash | 13.1 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Vomiting | 0.9 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Decreased appetite | 9.3 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | New muscle pain | 29.5 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Any aggravated muscle pain | 9.1 percentage of participants |
| 13vPnC (≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | New joint pain | 11.8 percentage of participants |
Secondary
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population
Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius \[C\]); Mild (≥37.5 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain.
Time frame: Day 1 through 14
Population: Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | Fever: any ≥37.5 degrees C | 3.4 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | Fever: mild ≥37.5 but <38.5 degrees C | 2.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | Fever: moderate ≥38.5 but <39 degrees C | 0.5 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | Fatigue | 31.2 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | Headache | 19.9 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | Chills | 12.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | Rash | 10.7 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | Vomiting | 2.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | Decreased appetite | 12.6 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | New muscle pain | 31.8 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | Any aggravated muscle pain | 10.1 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | New joint pain | 11.0 percentage of participants |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population | Any aggravated joint pain | 6.3 percentage of participants |
Secondary
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMCs calculated using all participants with available data for both the specified blood draws.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 1 | 4.65 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 3 | 1.38 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 4 | 3.63 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 9V | 6.55 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 14 | 16.73 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 18C | 10.47 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19A | 13.51 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19F | 4.99 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 23F | 9.38 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 5 | 6.74 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6A | 6.72 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6B | 6.71 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 7F | 8.90 mcg/mL |
| 13vPnC (≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19A | 27.09 mcg/mL |
| 13vPnC (≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 1 | 7.95 mcg/mL |
| 13vPnC (≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 5 | 10.32 mcg/mL |
| 13vPnC (≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 3 | 1.69 mcg/mL |
| 13vPnC (≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 19F | 11.92 mcg/mL |
| 13vPnC (≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 7F | 12.10 mcg/mL |
| 13vPnC (≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6B | 10.28 mcg/mL |
| 13vPnC (≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 9V | 14.22 mcg/mL |
| 13vPnC (≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 23F | 15.93 mcg/mL |
| 13vPnC (≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 14 | 22.12 mcg/mL |
| 13vPnC (≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 4 | 5.78 mcg/mL |
| 13vPnC (≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 18C | 18.53 mcg/mL |
| 13vPnC (≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years | Serotype 6A | 9.37 mcg/mL |
Secondary
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population
Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Time frame: 1 month after vaccination
Population: Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMCs calculated using all participants with available data for both the specified blood draws.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 1 | 6.05 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 3 | 1.53 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 4 | 4.57 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 5 | 8.34 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 6A | 7.93 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 6B | 8.31 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 7F | 10.36 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 9V | 9.62 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 14 | 19.23 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 18C | 13.90 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 19A | 19.13 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 19F | 7.77 mcg/mL |
| 13vPnC Overall Population (50 to 64 and ≥65 Years of Age) | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population | Serotype 23F | 12.23 mcg/mL |