Pneumococcal Conjugate Vaccine
Conditions
Keywords
Single site, single dose, Participated in Wyeth D118-P8
Brief summary
The purpose of this study is to assess the late immune response to further doses of pneumococcal conjugate vaccine more than 10 years after primary immunization with Prevnar (7vPnC) in infancy, as compared with individuals who did not receive Prevnar in infancy (the Prevnar naive cohort which received MnCC). The study will take place at a single study center. Study participants must have participated previously in a specific Wyeth Prevnar study (Study D118-P8) and must still be enrolled in the Northern California Kaiser Permanente (NCKP) health plan.
Interventions
BIOLOGICAL13-valent Pneumococcal Conjugate Vaccine
single injection, single dose, single site, 0.5 mL per dose.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* Fully vaccinated per-protocol (4 doses of vaccine given at 2, 4, 6, and 12-15 months of age) subjects enrolled in the Prevnar arm of Study D118-P8, OR * Fully vaccinated per-protocol subjects from the control arm of the same study that did not receive Prevnar after the close of Study D118-P8, or at any time following the study, AND * Still enrolled in NCKP health plan. * Subjects included in either group above must be in good health as determined by medical history, physical examination, and clinical judgment.
Exclusion criteria
* Previous receipt of pneumococcal polysaccharide vaccine. * History of documented recurrent pneumococcal otitis media or any occurence of pneumonia within past 12 months * History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site). * Known or suspected disease or dysfunction of the immune system, including: * HIV infection * Malignancy * Receipt of immunosuppressive therapy * Sickle cell hemoglobinopathy * Concomitant vaccination during the study period. * Known hypersensitivity to any component of Prevnar. * Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study, or could preclude the evaluation of the subject's response. * Receipt of immune globulin within the past 3 months. * Positive pregnancy test for menarchal female subjects. * Females who are breastfeeding. * For control subjects, previous receipt of Prevnar at any time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Day 28 (Visit 5) | Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay. |
| Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Day 7 (Visit 4) | Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay. |
| Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Day 28 (Visit 5) | Percentage of participants achieving predefined IgG antibody threshold ≥0.35 micrograms per milliliter (Mcg/mL) for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% confidence intervals (CIs) based on the observed percentage of participants. |
| Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Day 7 (Visit 4) | Percentage of participants achieving predefined IgG antibody threshold ≥0.35 Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. |
| Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Day 28 (Visit 5) | Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13. |
| Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Day 7 (Visit 4) | Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Baseline (Visit 1), Day 28 (Visit 5) | Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Baseline (Visit 1), Day 7 (Visit 4) | Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Baseline (Visit 1), Day 7 (Visit 4) | Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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. |
| Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Day 7 (Visit 4) | Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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 for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Day 28 (Visit 5) | Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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. |
| Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Day 7 (Visit 4) | Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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. |
| Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Day 28 (Visit 5) | Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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. |
| Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Baseline (Visit 1), Day 28 (Visit 5) | Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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. |
| Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Baseline (Visit 1), Day 28 (Visit 5) | Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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. |
| Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Baseline (Visit 1), Day 7 (Visit 4) | Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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. |
| Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Baseline (Visit 1), Day 7 (Visit 4) | Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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. |
| Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Baseline (Visit 1), Day 28 (Visit 5) | Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Baseline up to 4 days after vaccination on Day 1 | Local reactions reported using the diary card during the 4-day reactogenicity period after vaccination. Tenderness at injection site scaled as Any (tenderness present) or Significant (present and interfered with limb movement). Redness and swelling at injection site scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); or Severe (\> 7.0 cm). Participants may be represented in \>1 category. |
| Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Baseline up to 4 days after vaccination on Day 1 | Systemic events reported using the diary card during the 4-day reactogenicity period after vaccination. Temperature scaled as Fever ≥38 but ≤39 degrees Celsius (C) (mild), \>39 but ≤40 degrees C (moderate), or \>40 degrees C (severe). Presence of Decreased appetite, Irritability, Increased sleep, Decreased sleep, Rash, and Hives; also scaled as Mild (easily tolerated, minimal discomfort; not interfering with activities), Moderate (sufficiently discomforting to interfere with normal activities), or Severe (may prevent normal activities and require medical intervention). |
Countries
United States
Participant flow
Recruitment details
Participants were previously enrolled in Prevnar protocol D118-P8 (study duration 1995 to 1998) and were randomized to receive either 7-valent pneumococcal conjugate vaccine or meningococcal C conjugate vaccine in that study.
Participants by arm
| Arm | Count |
|---|---|
| 7vPnC / 13vPnC 13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8. | 38 |
| MnCC / 13vPnC 13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8. | 37 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | 7vPnC / 13vPnC | MnCC / 13vPnC | Total |
|---|---|---|---|
| Age Continuous | 12.6 years STANDARD_DEVIATION 1.1 | 13.1 years STANDARD_DEVIATION 0.9 | 12.8 years STANDARD_DEVIATION 1 |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 23 Participants | 21 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 38 / 38 | 36 / 36 |
| serious Total, serious adverse events | 0 / 38 | 0 / 36 |
Outcome results
Primary
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Percentage of participants achieving predefined IgG antibody threshold ≥0.35 Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants.
Time frame: Day 7 (Visit 4)
Population: Evaluable Immunogenicity population; N=number of participants with a determinate IgG antibody concentration for the serotypes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 9V | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 1 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 18C | 97.4 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 3 | 94.7 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 6B | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 5 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 19F | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 6A | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 14 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 7F | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 23F | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 19A | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 4 | 94.7 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 19A | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 4 | 85.7 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 6B | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 9V | 97.1 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 14 | 94.3 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 18C | 94.3 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 19F | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 23F | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 1 | 97.1 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 3 | 87.9 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 5 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 6A | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 7F | 100.0 observed percentage of participants |
Comparison: 7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-5.6, 25.5]
Comparison: 7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: 7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-6.9, 14.9]
Comparison: 7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-4.2, 19.2]
Comparison: 7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.3, 17]
Comparison: 7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.4, 10.3]
Comparison: 7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-6.9, 14.9]
Comparison: Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-7.4, 23.4]
Comparison: Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Primary
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Percentage of participants achieving predefined IgG antibody threshold ≥0.35 micrograms per milliliter (Mcg/mL) for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% confidence intervals (CIs) based on the observed percentage of participants.
Time frame: Day 28 (Visit 5)
Population: Evaluable Immunogenicity population: eligible participants based on all inclusion and exclusion criteria, had a baseline blood sample collection performed (Visit 1), received 1 dose of 13vPnC, and had Visit 5 blood sample collection performed, and at least 1 valid and determinate assay result at Visit 1 and also at Visit 5.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 9V | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 1 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 18C | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 3 | 94.7 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 6B | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 5 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 19F | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 6A | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 14 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 7F | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 23F | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 19A | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 4 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 19A | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 4 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 6B | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 9V | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 14 | 97.1 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 18C | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 19F | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 23F | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 1 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 3 | 97.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 5 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 6A | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 7F | 100.0 observed percentage of participants |
Comparison: 7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: 7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: 7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: 7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-6.9, 14.9]
Comparison: 7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: 7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.4, 10.3]
Comparison: 7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-15.7, 10.9]
Comparison: Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Primary
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.
Time frame: Day 7 (Visit 4)
Population: Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 9V | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 1 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 18C | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 3 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 6B | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 5 | 97.4 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 19F | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 6A | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 14 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 7F | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 23F | 97.3 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 19A | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 4 | 97.4 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 19A | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 4 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 6B | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 9V | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 14 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 18C | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 19F | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 23F | 94.3 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 1 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 3 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 5 | 94.1 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 6A | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 7F | 100.0 observed percentage of participants |
Comparison: 7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-13.9, 8]
Comparison: 7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-10.2, 10.6]
Comparison: 7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.4, 10.3]
Comparison: 7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10.3]
Comparison: 7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-10, 10.1]
Comparison: 7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-10.1, 10.5]
Comparison: 7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.1, 16.6]
Comparison: Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-10, 10.1]
Comparison: Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.4, 10.3]
Comparison: Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-8.6, 17.2]
Comparison: Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.7, 10.6]
Comparison: Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Primary
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.
Time frame: Day 28 (Visit 5)
Population: Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 9V | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 1 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 18C | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 3 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 6B | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 5 | 97.4 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 19F | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 6A | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 14 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 7F | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 23F | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 19A | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 4 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 19A | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 4 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 6B | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 9V | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 14 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 18C | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 19F | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 23F | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 1 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 3 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 5 | 94.3 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 6A | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 7F | 100.0 observed percentage of participants |
Comparison: 7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-10.2, 10.9]
Comparison: 7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-10, 10.1]
Comparison: 7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.4, 10.3]
Comparison: 7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.4, 10.3]
Comparison: 7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: 7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.4, 10.3]
Comparison: 7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-10, 10.1]
Comparison: Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.4, 10.3]
Comparison: Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.3, 17]
Comparison: Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.4, 10.3]
Comparison: Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-10, 10.1]
Comparison: Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Primary
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
Time frame: Day 7 (Visit 4)
Population: Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 9V | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 1 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 18C | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 3 | 97.4 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 6B | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 5 | 89.5 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 19F | 94.3 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 6A | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 14 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 7F | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 23F | 97.3 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 19A | 97.4 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 4 | 97.4 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 19A | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 4 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 6B | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 9V | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 14 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 18C | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 19F | 97.1 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 23F | 94.3 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 1 | 97.1 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 3 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 5 | 88.2 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 6A | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 7F | 97.0 observed percentage of participants |
Comparison: 7vPnC serotype 4: difference in proportions, \[7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-13.9, 8]
Comparison: 7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-10.2, 10.6]
Comparison: 7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.4, 10.3]
Comparison: 7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10.3]
Comparison: 7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-10, 10.1]
Comparison: 7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-16.8, 10.1]
Comparison: 7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.1, 16.6]
Comparison: Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-7.1, 15]
Comparison: Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-13.9, 8]
Comparison: Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-14.8, 18.2]
Comparison: Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-6.8, 15.8]
Comparison: Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-13.9, 7.6]
Primary
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
Time frame: Day 28 (Visit 5)
Population: Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 9V | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 1 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 18C | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 3 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 6B | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 5 | 89.5 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 19F | 97.4 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 6A | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 14 | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 7F | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 23F | 100.0 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 19A | 97.4 observed percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 4 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 19A | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 4 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 6B | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 9V | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 14 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 18C | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 19F | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 23F | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 1 | 97.1 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 3 | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 5 | 88.6 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 6A | 100.0 observed percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 7F | 100.0 observed percentage of participants |
Comparison: 7vPnC serotype 4: difference in proportions, \[7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-10.2, 10.9]
Comparison: 7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-10, 10.1]
Comparison: 7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.4, 10.3]
Comparison: 7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.4, 10.3]
Comparison: 7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: 7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-13.9, 8]
Comparison: 7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-10, 10.1]
Comparison: Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-6.7, 15.3]
Comparison: Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.5, 10]
Comparison: Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-15, 17.6]
Comparison: Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-9.4, 10.3]
Comparison: Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-10, 10.1]
Comparison: Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.95% CI: [-13.9, 7.6]
Secondary
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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: Day 7 (Visit 4)
Population: Evaluable Immunogenicity population; GMCs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody concentration for the serotypes.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 9V | 5.75 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 1 | 3.98 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 18C | 3.09 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 3 | 2.02 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 6B | 29.46 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 5 | 5.40 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 19F | 7.66 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 6A | 13.60 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 14 | 10.25 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 7F | 4.70 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 23F | 10.56 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 19A | 13.40 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 4 | 3.00 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 19A | 12.03 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 4 | 1.37 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 6B | 9.42 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 9V | 3.41 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 14 | 5.22 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 18C | 3.45 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 19F | 4.85 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 23F | 6.51 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 1 | 2.83 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 3 | 1.40 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 5 | 5.12 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 6A | 7.25 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 7F | 3.17 Mcg/mL |
Comparison: 7vPnC serotype 4: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [1.26, 3.79]
Comparison: 7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [1.84, 5.32]
Comparison: 7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [1.13, 2.51]
Comparison: 7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.95, 4.07]
Comparison: 7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.51, 1.56]
Comparison: 7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.93, 2.66]
Comparison: 7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.97, 2.73]
Comparison: Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.83, 2.39]
Comparison: Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.89, 2.34]
Comparison: Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.68, 1.64]
Comparison: 7vPnC serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [1.05, 3.35]
Comparison: Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.9, 2.44]
Comparison: Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.75, 1.66]
Secondary
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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: Day 28 (Visit 5)
Population: Evaluable Immunogenicity population; GMCs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody concentration for the serotypes.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 9V | 8.72 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 1 | 9.55 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 18C | 5.72 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 3 | 2.13 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 6B | 66.72 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 5 | 6.80 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 19F | 14.17 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 6A | 29.11 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 14 | 41.45 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 7F | 9.92 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 23F | 17.20 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 19A | 21.29 Mcg/mL |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 4 | 5.73 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 19A | 20.17 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 4 | 2.92 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 6B | 22.62 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 9V | 4.70 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 14 | 18.50 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 18C | 9.04 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 19F | 15.80 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 23F | 20.80 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 1 | 5.63 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 3 | 1.71 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 5 | 7.52 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 6A | 16.08 Mcg/mL |
| MnCC / 13vPnC | Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 7F | 5.75 Mcg/mL |
Comparison: Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.67, 1.66]
Comparison: 7vPnC serotype 4: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [1.31, 2.95]
Comparison: 7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [1.78, 4.9]
Comparison: 7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [1.25, 2.75]
Comparison: 7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [1.11, 4.53]
Comparison: 7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.38, 1.05]
Comparison: 7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.5, 1.62]
Comparison: 7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.48, 1.43]
Comparison: Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.96, 3]
Comparison: Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.79, 1.96]
Comparison: Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.54, 1.52]
Comparison: Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.98, 3.34]
Comparison: Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [1.05, 2.83]
Secondary
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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: Day 7 (Visit 4)
Population: Evaluable Immunogenicity population; GMTs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody titer for the serotypes.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 9V | 6865 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 1 | 379 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 18C | 5833 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 3 | 117 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 6B | 8082 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 5 | 200 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 19F | 1243 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 6A | 8534 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 14 | 3596 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 7F | 4750 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 23F | 1575 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 19A | 1504 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 4 | 5567 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 19A | 1761 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 4 | 8339 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 6B | 6450 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 9V | 7806 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 14 | 5994 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 18C | 5266 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 19F | 1855 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | 7vPnC serotype 23F | 1141 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 1 | 393 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 3 | 104 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 5 | 258 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 6A | 6199 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4) | Additional serotype 7F | 3760 Titer |
Comparison: 7vPnC serotype 4: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.35, 1.27]
Comparison: 7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.77, 2.05]
Comparison: 7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.54, 1.44]
Comparison: 7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.38, 0.95]
Comparison: 7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.64, 1.91]
Comparison: 7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.28, 1.62]
Comparison: 7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.68, 2.81]
Comparison: Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.53, 1.77]
Comparison: Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.69, 1.81]
Comparison: Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.32, 1.85]
Comparison: Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.8, 2.36]
Comparison: Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.65, 2.44]
Comparison: Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.46, 1.57]
Secondary
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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: Day 28 (Visit 5)
Population: Evaluable Immunogenicity population; GMTs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody titer for the serotypes.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 9V | 6346 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 1 | 449 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 18C | 5090 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 3 | 113 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 6B | 11451 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 5 | 296 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 19F | 1623 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 6A | 9458 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 14 | 5898 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 7F | 6740 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 23F | 2752 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 19A | 2120 Titer |
| 7vPnC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 4 | 4626 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 19A | 2340 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 4 | 6065 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 6B | 10380 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 9V | 7555 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 14 | 7031 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 18C | 6005 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 19F | 2696 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | 7vPnC serotype 23F | 4841 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 1 | 347 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 3 | 99 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 5 | 336 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 6A | 10842 Titer |
| MnCC / 13vPnC | Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) | Additional serotype 7F | 6050 Titer |
Comparison: 7vPnC serotype 4: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.5, 1.17]
Comparison: 7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.7, 1.73]
Comparison: 7vPnC serotype 9V: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.61, 1.15]
Comparison: 7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.56, 1.25]
Comparison: 7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.51, 1.4]
Comparison: 7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.32, 1.12]
Comparison: 7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.38, 0.85]
Comparison: Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.75, 2.22]
Comparison: Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.82, 1.61]
Comparison: Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.36, 2.13]
Comparison: Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.55, 1.39]
Comparison: Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.73, 1.7]
Comparison: Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).95% CI: [0.5, 1.63]
Secondary
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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: Baseline (Visit 1), Day 7 (Visit 4)
Population: Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 9V | 1.54 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 1 | 1.04 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 18C | 0.75 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 3 | 1.30 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 6B | 5.89 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 5 | 3.24 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 19F | 2.94 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 6A | 3.78 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 14 | 0.58 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 7F | 1.38 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 23F | 2.51 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 19A | 7.05 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 4 | 0.20 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 19A | 13.40 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 4 | 3.21 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 6B | 29.46 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 9V | 5.96 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 14 | 10.25 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 18C | 3.17 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 19F | 7.46 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 23F | 10.56 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 1 | 4.42 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 3 | 2.12 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 5 | 5.40 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 6A | 13.60 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 7F | 4.70 Mcg/mL |
Comparison: Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [1.3, 2.05]
Comparison: 7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [9.16, 27.46]
Comparison: 7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [3.5, 7.16]
Comparison: 7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [2.93, 5.09]
Comparison: 7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [11.11, 27.79]
Comparison: 7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [2.86, 6.23]
Comparison: 7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [1.78, 3.62]
Comparison: 7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [2.86, 6.19]
Comparison: Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [2.79, 6.42]
Comparison: Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [1.3, 2.14]
Comparison: Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [2.39, 5.42]
Comparison: Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [2.42, 4.82]
Comparison: Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [1.6, 2.26]
Secondary
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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: Baseline (Visit 1), Day 28 (Visit 5)
Population: Evaluable Immunogenicity population. GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 9V | 1.54 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 1 | 1.04 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 18C | 0.75 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 3 | 1.30 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 6B | 5.89 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 5 | 3.24 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 19F | 2.94 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 6A | 3.78 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 14 | 0.58 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 7F | 1.38 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 23F | 2.51 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 19A | 7.05 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 4 | 0.20 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 19A | 21.29 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 4 | 5.96 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 6B | 66.72 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 9V | 8.62 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 14 | 41.45 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 18C | 5.93 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 19F | 13.41 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 23F | 17.20 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 1 | 11.59 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 3 | 2.19 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 5 | 6.80 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 6A | 29.11 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 7F | 9.92 Mcg/mL |
Comparison: 7vPnC serotype 4: Geometric mean fold rises (GMFRs) were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [17.61, 49.33]
Comparison: 7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [8.49, 15.13]
Comparison: 7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [4.06, 7.67]
Comparison: 7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [40.74, 124.08]
Comparison: 7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [4.92, 12.73]
Comparison: 7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [2.87, 7.26]
Comparison: 7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [4.51, 10.42]
Comparison: Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [6.98, 17.64]
Comparison: Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [1.37, 2.07]
Comparison: Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [1.52, 2.9]
Comparison: Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [4.77, 12.42]
Comparison: Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [4.95, 10.48]
Comparison: Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [2.23, 4.1]
Secondary
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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: Baseline (Visit 1), Day 7 (Visit 4)
Population: Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 9V | 1.69 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 1 | 0.70 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 18C | 0.72 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 3 | 1.11 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 6B | 3.97 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 5 | 3.83 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 19F | 2.01 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 6A | 3.82 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 14 | 0.79 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 7F | 1.12 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 23F | 2.31 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 19A | 6.18 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 4 | 0.15 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 19A | 12.03 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 4 | 1.21 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 6B | 9.42 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 9V | 3.41 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 14 | 5.22 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 18C | 3.53 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 19F | 5.47 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 23F | 6.51 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 1 | 2.65 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 3 | 1.46 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 5 | 5.00 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 6A | 7.79 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 7F | 3.21 Mcg/mL |
Comparison: 7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [4.5, 15.56]
Comparison: 7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [1.78, 3.16]
Comparison: 7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [1.63, 2.49]
Comparison: 7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [4.31, 10.15]
Comparison: 7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [3.34, 7.26]
Comparison: 7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [2.08, 3.57]
Comparison: 7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [2.08, 3.83]
Comparison: Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [2.8, 5.13]
Comparison: Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [1.11, 1.57]
Comparison: Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [1.05, 1.61]
Comparison: Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [1.51, 2.75]
Comparison: Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [2.19, 3.77]
Comparison: Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [1.59, 2.39]
Secondary
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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: Baseline (Visit 1), Day 28 (Visit 5)
Population: Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 9V | 1.69 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 1 | 0.70 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 18C | 0.72 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 3 | 1.16 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 6B | 3.97 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 5 | 3.83 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 19F | 2.01 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 6A | 3.82 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 14 | 0.79 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 7F | 1.12 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 23F | 2.31 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 19A | 6.18 Mcg/mL |
| 7vPnC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 4 | 0.15 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 19A | 20.17 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 4 | 2.86 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 6B | 22.62 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 9V | 4.70 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 14 | 18.50 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 18C | 9.79 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 19F | 18.02 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 23F | 20.80 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 1 | 5.30 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 3 | 1.81 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 5 | 7.39 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 6A | 17.05 Mcg/mL |
| MnCC / 13vPnC | Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 7F | 5.94 Mcg/mL |
Comparison: 7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [9.99, 38.77]
Comparison: 7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [3.9, 8.33]
Comparison: 7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [2.16, 3.57]
Comparison: 7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [13.17, 41.79]
Comparison: 7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [8.94, 20.92]
Comparison: 7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [6.21, 12.97]
Comparison: 7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [5.91, 13.72]
Comparison: Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [5.36, 10.72]
Comparison: Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [1.3, 1.86]
Comparison: Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [1.43, 2.6]
Comparison: Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [3.09, 6.45]
Comparison: Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [3.65, 7.75]
Comparison: Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [2.49, 4.28]
Secondary
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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: Baseline (Visit 1), Day 7 (Visit 4)
Population: Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 9V | 43 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 1 | 6 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 18C | 58 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 3 | 11 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 6B | 1034 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 5 | 4 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 19F | 40 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 6A | 17 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 14 | 148 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 7F | 60 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 23F | 79 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 19A | 76 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 4 | 19 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 19A | 1345 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 4 | 5449 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 6B | 7885 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 9V | 6497 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 14 | 3497 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 18C | 5922 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 19F | 1243 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 23F | 1487 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 1 | 367 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 3 | 119 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 5 | 185 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 6A | 8072 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 7F | 4601 Titer |
Comparison: 7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [76.65, 1035.49]
Comparison: 7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [3.47, 16.75]
Comparison: 7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [42.01, 545.84]
Comparison: 7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [8.67, 64.54]
Comparison: 7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [32, 325.4]
Comparison: 7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [12.71, 76.13]
Comparison: 7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [6.82, 51.39]
Comparison: Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [37.33, 111.18]
Comparison: Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [6.64, 18.52]
Comparison: Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [23.09, 73.48]
Comparison: Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [171.63, 1339.96]
Comparison: Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [21.63, 270.02]
Comparison: Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [7.61, 41.08]
Secondary
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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: Baseline (Visit 1), Day 28 (Visit 5)
Population: Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 9V | 43 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 1 | 6 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 18C | 54 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 3 | 11 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 6B | 1024 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 5 | 4 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 19F | 33 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 6A | 17 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 14 | 159 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 7F | 60 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 23F | 87 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 19A | 76 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 4 | 22 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 19A | 1869 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 4 | 4535 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 6B | 11939 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 9V | 6709 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 14 | 5946 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 18C | 5067 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 19F | 1623 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 23F | 2799 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 1 | 440 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 3 | 111 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 5 | 277 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 6A | 9029 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 7F | 7036 Titer |
Comparison: 7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [55.11, 739.05]
Comparison: 7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [5.2, 26.1]
Comparison: 7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [48.72, 501.86]
Comparison: 7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [13.71, 102.31]
Comparison: 7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [30.99, 284.31]
Comparison: 7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [23.27, 101.97]
Comparison: 7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [11.99, 85.81]
Comparison: Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [50.42, 120.94]
Comparison: Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [6.8, 15.72]
Comparison: Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [32.75, 116.34]
Comparison: Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [212.04, 1357.19]
Comparison: Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [33.28, 410.33]
Comparison: Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [11.3, 53.42]
Secondary
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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: Baseline (Visit 1), Day 7 (Visit 4)
Population: Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 9V | 116 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 1 | 5 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 18C | 25 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 3 | 12 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 6B | 405 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 5 | 4 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 19F | 20 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 6A | 23 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 14 | 280 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 7F | 95 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 23F | 11 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 19A | 39 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 4 | 40 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 19A | 1763 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 4 | 6782 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 6B | 7195 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 9V | 7855 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 14 | 6209 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 18C | 5193 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 19F | 1855 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | 7vPnC serotype 23F | 991 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 1 | 385 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 3 | 101 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 5 | 258 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 6A | 6107 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 | Additional serotype 7F | 3577 Titer |
Comparison: 7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [22.24, 1301.79]
Comparison: 7vPnC serotype 6B: GMRFs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [5.27, 59.91]
Comparison: 7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [18.45, 249.02]
Comparison: 7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [7.94, 61.88]
Comparison: 7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [70.04, 602.78]
Comparison: 7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [40.28, 203.27]
Comparison: 7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [36.25, 232.13]
Comparison: Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [47.32, 120.91]
Comparison: Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [5.21, 14.4]
Comparison: Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [31.06, 115.92]
Comparison: Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [105.09, 692.6]
Comparison: Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [10.85, 131.09]
Comparison: Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [21.31, 94.01]
Secondary
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for 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: Baseline (Visit 1), Day 28 (Visit 5)
Population: Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 9V | 120 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 1 | 5 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 18C | 25 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 3 | 11 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 6B | 288 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 5 | 4 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 19F | 23 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 6A | 24 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 14 | 262 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 7F | 76 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 23F | 11 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 19A | 39 Titer |
| 7vPnC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 4 | 28 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 19A | 2424 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 4 | 4704 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 6B | 11607 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 9V | 7457 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 14 | 7006 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 18C | 5736 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 19F | 2696 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | 7vPnC serotype 23F | 5197 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 1 | 341 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 3 | 98 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 5 | 336 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 6A | 10488 Titer |
| MnCC / 13vPnC | Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 | Additional serotype 7F | 6098 Titer |
Comparison: 7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [20.22, 1409.76]
Comparison: 7vPnC serotype 6B: GMRFs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [10.97, 148.44]
Comparison: 7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [18.83, 203.72]
Comparison: 7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [9.67, 73.84]
Comparison: 7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [79.81, 645.29]
Comparison: 7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [54.54, 250.13]
Comparison: 7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [207.01, 1117.69]
Comparison: Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [41.8, 105.75]
Comparison: Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [5.36, 13.94]
Comparison: Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [41.38, 147.8]
Comparison: Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [169.52, 1132.43]
Comparison: Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [23.28, 274.82]
Comparison: Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.95% CI: [28.73, 131.76]
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination
Local reactions reported using the diary card during the 4-day reactogenicity period after vaccination. Tenderness at injection site scaled as Any (tenderness present) or Significant (present and interfered with limb movement). Redness and swelling at injection site scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); or Severe (\> 7.0 cm). Participants may be represented in \>1 category.
Time frame: Baseline up to 4 days after vaccination on Day 1
Population: Safety population included all participants who received the vaccine. N=number of participants with analyzable data for reactogenicity events (reported Yes for at least 1 day or No for all days).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Tenderness: Any | 92.1 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Swelling: Moderate | 10.5 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Swelling: Any | 10.5 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Redness: Any | 5.3 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Tenderness: Significant | 10.5 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Redness: Mild | 0.0 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Swelling: Mild | 2.6 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Redness: Moderate | 5.3 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Swelling: Mild | 2.8 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Tenderness: Any | 86.1 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Tenderness: Significant | 19.4 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Swelling: Any | 5.6 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Redness: Moderate | 2.8 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Swelling: Moderate | 2.8 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Redness: Any | 5.6 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination | Redness: Mild | 2.8 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Systemic events reported using the diary card during the 4-day reactogenicity period after vaccination. Temperature scaled as Fever ≥38 but ≤39 degrees Celsius (C) (mild), \>39 but ≤40 degrees C (moderate), or \>40 degrees C (severe). Presence of Decreased appetite, Irritability, Increased sleep, Decreased sleep, Rash, and Hives; also scaled as Mild (easily tolerated, minimal discomfort; not interfering with activities), Moderate (sufficiently discomforting to interfere with normal activities), or Severe (may prevent normal activities and require medical intervention).
Time frame: Baseline up to 4 days after vaccination on Day 1
Population: Safety population; N=number of participants with analyzable data for reactogenicity events (reported Yes for at least 1 day or No for all days).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Fever ≥38 but ≤39 degrees C | 2.9 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Decreased appetite | 7.9 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Decreased appetite: Mild | 7.9 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Decreased appetite: Moderate | 2.6 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Irritability | 18.4 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Irritability: Mild | 13.2 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Irritability: Moderate | 5.3 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Increased sleep | 26.3 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Increased sleep: Mild | 15.8 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Increased sleep: Moderate | 13.2 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Increased sleep: Severe | 2.6 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Decreased sleep | 7.9 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Decreased sleep: Mild | 5.3 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Decreased sleep: Moderate | 2.6 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Rash | 5.3 percentage of participants |
| 7vPnC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Rash: Mild | 5.3 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Rash: Mild | 0.0 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Fever ≥38 but ≤39 degrees C | 0.0 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Increased sleep: Mild | 25.0 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Decreased appetite | 16.7 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Decreased sleep: Mild | 8.3 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Decreased appetite: Mild | 11.1 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Increased sleep: Moderate | 13.9 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Decreased appetite: Moderate | 8.3 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Rash | 0.0 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Irritability | 13.9 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Increased sleep: Severe | 0.0 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Irritability: Mild | 11.1 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Decreased sleep: Moderate | 2.8 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Irritability: Moderate | 5.6 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Decreased sleep | 11.1 percentage of participants |
| MnCC / 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination | Increased sleep | 33.3 percentage of participants |