Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B1851014 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Subjects received Prevnar in study D118-P8 |
|
| 2 | Experimental | Subjects received MnCC in study D118-P8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent Pneumococcal Conjugate Vaccine | Biological | single injection, single dose, single site, 0.5 mL per dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 (Visit 5) |
| 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. | Day 7 (Visit 4) |
| 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. | Day 28 (Visit 5) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Hayward | California | 94545 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24008739 | Derived | Klein NP, Ensor K, Jouve S, Northington R, Moscariello M, McGovern PC. Long-term immune responses to pneumococcal conjugate vaccines in children previously vaccinated with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Sep;32(9):990-7. doi: 10.1097/INF.0b013e3182959f34. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 7vPnC / 13vPnC | 13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8. |
| FG001 | MnCC / 13vPnC | 13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 7vPnC / 13vPnC | 13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8. |
| BG001 | MnCC / 13vPnC | 13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | observed percentage of participants | Day 28 (Visit 5) |
|
Baseline up to Day 4 after vaccination for local reactions and systemic events or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess AEs)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 7vPnC / 13vPnC | 13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8. Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods). Other Adverse Events N=22; Local reactions N=38; Systemic events N=38. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphoid tissue hyperplasia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 13-valent Pneumococcal Conjugate Vaccine | Biological | single injection, single dose, single site, 0.5 mL per dose. |
|
|
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.
| Day 7 (Visit 4) |
| 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. | Day 28 (Visit 5) |
| 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. | Day 7 (Visit 4) |
| Baseline (Visit 1), Day 28 (Visit 5) |
| 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. | Baseline (Visit 1), Day 28 (Visit 5) |
| 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. | Baseline (Visit 1), Day 7 (Visit 4) |
| 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. | Baseline (Visit 1), Day 7 (Visit 4) |
| 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. | Baseline (Visit 1), Day 28 (Visit 5) |
| 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. | Baseline (Visit 1), Day 28 (Visit 5) |
| 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. | Baseline (Visit 1), Day 7 (Visit 4) |
| 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. | Baseline (Visit 1), Day 7 (Visit 4) |
| 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. | Day 28 (Visit 5) |
| 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. | Day 7 (Visit 4) |
| 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. | Day 28 (Visit 5) |
| 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. | Day 7 (Visit 4) |
| Baseline up to 4 days after vaccination on Day 1 |
| 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). | Baseline up to 4 days after vaccination on Day 1 |
| San Jose |
| California |
| 95119 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8. |
| OG001 | MnCC / 13vPnC | 13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8. |
|
|
|
| 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. | Evaluable Immunogenicity population; N=number of participants with a determinate IgG antibody concentration for the serotypes. | Posted | Number | 95% Confidence Interval | observed percentage of participants | Day 7 (Visit 4) |
|
|
|
|
| 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. | Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes. | Posted | Number | 95% Confidence Interval | observed percentage of participants | Day 28 (Visit 5) |
|
|
|
|
| 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. | Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes. | Posted | Number | 95% Confidence Interval | observed percentage of participants | Day 7 (Visit 4) |
|
|
|
|
| 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. | Evaluable Immunogenicity population. GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. | Posted | Geometric Mean | 95% Confidence Interval | Mcg/mL | Baseline (Visit 1), Day 28 (Visit 5) |
|
|
|
|
| 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. | Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. | Posted | Geometric Mean | 95% Confidence Interval | Mcg/mL | Baseline (Visit 1), Day 28 (Visit 5) |
|
|
|
|
| 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. | Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. | Posted | Geometric Mean | 95% Confidence Interval | Mcg/mL | Baseline (Visit 1), Day 7 (Visit 4) |
|
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Mcg/mL | Baseline (Visit 1), Day 7 (Visit 4) |
|
|
|
|
| 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. | Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline (Visit 1), Day 28 (Visit 5) |
|
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline (Visit 1), Day 28 (Visit 5) |
|
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline (Visit 1), Day 7 (Visit 4) |
|
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline (Visit 1), Day 7 (Visit 4) |
|
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Mcg/mL | Day 28 (Visit 5) |
|
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Mcg/mL | Day 7 (Visit 4) |
|
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 28 (Visit 5) |
|
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 7 (Visit 4) |
|
|
|
|
| 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. | 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). | Posted | Number | percentage of participants | Baseline up to 4 days after vaccination on Day 1 |
|
|
|
| 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). | Safety population; N=number of participants with analyzable data for reactogenicity events (reported Yes for at least 1 day or No for all days). | Posted | Number | percentage of participants | Baseline up to 4 days after vaccination on Day 1 |
|
|
|
| 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. | Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes. | Posted | Number | 95% Confidence Interval | observed percentage of participants | Day 28 (Visit 5) |
|
|
|
|
| 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. | Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes. | Posted | Number | 95% Confidence Interval | observed percentage of participants | Day 7 (Visit 4) |
|
|
|
|
| 0 |
| 38 |
| 38 |
| 38 |
| EG001 | MnCC / 13vPnC | 13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8. Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods). Other Adverse Events N=20; Local reactions N=36; Systemic events N=36. | 0 | 36 | 36 | 36 |
| Palpitations | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Congenital flat feet | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Ear congestion | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Gastritis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Avulsion fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Patellofemoral pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Tenderness: Any | Skin and subcutaneous tissue disorders | Local Reaction | Systematic Assessment |
|
| Tenderness: Significant | Skin and subcutaneous tissue disorders | Local Reaction | Systematic Assessment |
|
| Swelling: Any | Skin and subcutaneous tissue disorders | Local Reaction | Systematic Assessment |
|
| Swelling: Mild | Skin and subcutaneous tissue disorders | Local Reaction | Systematic Assessment |
|
| Swelling: Moderate | Skin and subcutaneous tissue disorders | Local Reaction | Systematic Assessment |
|
| Redness: Any | Skin and subcutaneous tissue disorders | Local Reaction | Systematic Assessment |
|
| Redness: Mild | Skin and subcutaneous tissue disorders | Local Reaction | Systematic Assessment |
|
| Redness: Moderate | Skin and subcutaneous tissue disorders | Local Reaction | Systematic Assessment |
|
| Fever ≥38 degrees C but ≤39 degrees C | General disorders | Systemic Event | Systematic Assessment |
|
| Decreased appetite | General disorders | Systemic Event | Systematic Assessment |
|
| Decreased appetite: Mild | General disorders | Systemic Event | Systematic Assessment |
|
| Decreased appetite: Moderate | General disorders | Systemic Event | Systematic Assessment |
|
| Irritability | General disorders | Systemic Event | Systematic Assessment |
|
| Irritability: Mild | General disorders | Systemic Event | Systematic Assessment |
|
| Irritability: Moderate | General disorders | Systemic Event | Systematic Assessment |
|
| Increased sleep | General disorders | Systemic Event | Systematic Assessment |
|
| Increased sleep: Mild | General disorders | Systemic Event | Systematic Assessment |
|
| Increased sleep: Moderate | General disorders | Systemic Event | Systematic Assessment |
|
| Increased sleep: Severe | General disorders | Systemic Event | Systematic Assessment |
|
| Decreased sleep | General disorders | Systemic Event | Systematic Assessment |
|
| Decreased sleep: Mild | General disorders | Systemic Event | Systematic Assessment |
|
| Decreased sleep: Moderate | General disorders | Systemic Event | Systematic Assessment |
|
| Rash | General disorders | Systemic Event | Systematic Assessment |
|
| Rash: Mild | General disorders | Systemic Event | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
| difference in proportions |
| 0.0 |
| 2-Sided |
| 95 |
| -9.5 |
| 10.0 |
| No |
| Superiority or Other |
| 7vPnC serotype 9V: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 2.9 | 2-Sided | 95 | -6.9 | 14.9 | No | Superiority or Other |
| 7vPnC serotype 14: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 5.7 | 2-Sided | 95 | -4.2 | 19.2 | No | Superiority or Other |
| 7vPnC serotype 18C: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 3.1 | 2-Sided | 95 | -9.3 | 17.0 | No | Superiority or Other |
| 7vPnC serotype 19F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.4 | 10.3 | No | Superiority or Other |
| 7vPnC serotype 23F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.0 | No | Superiority or Other |
| Additional serotype 1: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 2.9 | 2-Sided | 95 | -6.9 | 14.9 | No | Superiority or Other |
| Additional serotype 3: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 6.9 | 2-Sided | 95 | -7.4 | 23.4 | No | Superiority or Other |
| Additional serotype 5: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.0 | No | Superiority or Other |
| Additional serotype 6A: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.0 | No | Superiority or Other |
| Additional serotype 7F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.0 | No | Superiority or Other |
| Additional serotype 19A: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.0 | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
| difference in proportions |
| 0.0 |
| 2-Sided |
| 95 |
| -10.0 |
| 10.1 |
| No |
| Superiority or Other |
| 7vPnC serotype 9V: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.4 | 10.3 | No | Superiority or Other |
| 7vPnC serotype 14: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.4 | 10.3 | No | Superiority or Other |
| 7vPnC serotype 18C: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.0 | No | Superiority or Other |
| 7vPnC serotype 19F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | -2.6 | 2-Sided | 95 | -13.9 | 8.0 | No | Superiority or Other |
| 7vPnC serotype 23F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -10.0 | 10.1 | No | Superiority or Other |
| Additional serotype 1: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 2.9 | 2-Sided | 95 | -6.7 | 15.3 | No | Superiority or Other |
| Additional serotype 3: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.0 | No | Superiority or Other |
| Additional serotype 5: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.9 | 2-Sided | 95 | -15.0 | 17.6 | No | Superiority or Other |
| Additional serotype 6A: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.4 | 10.3 | No | Superiority or Other |
| Additional serotype 7F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -10.0 | 10.1 | No | Superiority or Other |
| Additional serotype 19A: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | -2.6 | 2-Sided | 95 | -13.9 | 7.6 | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
| difference in proportions |
| 0.0 |
| 2-Sided |
| 95 |
| -10.2 |
| 10.6 |
| No |
| Superiority or Other |
| 7vPnC serotype 9V: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.4 | 10.3 | No | Superiority or Other |
| 7vPnC serotype 14: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.3 | No | Superiority or Other |
| 7vPnC serotype 18C: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -10.0 | 10.1 | No | Superiority or Other |
| 7vPnC serotype 19F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | -2.8 | 2-Sided | 95 | -16.8 | 10.1 | No | Superiority or Other |
| 7vPnC serotype 23F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 3.0 | 2-Sided | 95 | -9.1 | 16.6 | No | Superiority or Other |
| Additional serotype 1: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 2.9 | 2-Sided | 95 | -7.1 | 15.0 | No | Superiority or Other |
| Additional serotype 3: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | -2.6 | 2-Sided | 95 | -13.9 | 8.0 | No | Superiority or Other |
| Additional serotype 5: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 1.2 | 2-Sided | 95 | -14.8 | 18.2 | No | Superiority or Other |
| Additional serotype 6A: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.0 | No | Superiority or Other |
| Additional serotype 7F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 3.0 | 2-Sided | 95 | -6.8 | 15.8 | No | Superiority or Other |
| Additional serotype 19A: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | -2.6 | 2-Sided | 95 | -13.9 | 7.6 | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
| 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. | geometric mean fold rise | 11.34 | 2-Sided | 95 | 8.49 | 15.13 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 5.58 | 2-Sided | 95 | 4.06 | 7.67 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 71.09 | 2-Sided | 95 | 40.74 | 124.08 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 7.91 | 2-Sided | 95 | 4.92 | 12.73 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 4.56 | 2-Sided | 95 | 2.87 | 7.26 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 6.85 | 2-Sided | 95 | 4.51 | 10.42 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 11.10 | 2-Sided | 95 | 6.98 | 17.64 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 1.68 | 2-Sided | 95 | 1.37 | 2.07 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 2.10 | 2-Sided | 95 | 1.52 | 2.90 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 7.70 | 2-Sided | 95 | 4.77 | 12.42 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 7.20 | 2-Sided | 95 | 4.95 | 10.48 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 3.02 | 2-Sided | 95 | 2.23 | 4.10 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
| 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. | geometric mean fold rise | 5.70 | 2-Sided | 95 | 3.90 | 8.33 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 2.78 | 2-Sided | 95 | 2.16 | 3.57 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 23.46 | 2-Sided | 95 | 13.17 | 41.79 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 13.68 | 2-Sided | 95 | 8.94 | 20.92 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 8.98 | 2-Sided | 95 | 6.21 | 12.97 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 9.00 | 2-Sided | 95 | 5.91 | 13.72 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 7.58 | 2-Sided | 95 | 5.36 | 10.72 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 1.56 | 2-Sided | 95 | 1.30 | 1.86 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 1.93 | 2-Sided | 95 | 1.43 | 2.60 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 4.46 | 2-Sided | 95 | 3.09 | 6.45 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 5.32 | 2-Sided | 95 | 3.65 | 7.75 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 3.27 | 2-Sided | 95 | 2.49 | 4.28 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
| 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. | geometric mean fold rise | 5.01 | 2-Sided | 95 | 3.50 | 7.16 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 3.86 | 2-Sided | 95 | 2.93 | 5.09 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 17.57 | 2-Sided | 95 | 11.11 | 27.79 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 4.22 | 2-Sided | 95 | 2.86 | 6.23 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 2.54 | 2-Sided | 95 | 1.78 | 3.62 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 4.21 | 2-Sided | 95 | 2.86 | 6.19 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 4.23 | 2-Sided | 95 | 2.79 | 6.42 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 1.63 | 2-Sided | 95 | 1.30 | 2.05 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 1.67 | 2-Sided | 95 | 1.30 | 2.14 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 3.60 | 2-Sided | 95 | 2.39 | 5.42 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 3.41 | 2-Sided | 95 | 2.42 | 4.82 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 1.90 | 2-Sided | 95 | 1.60 | 2.26 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
| 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. | geometric mean fold rise | 2.37 | 2-Sided | 95 | 1.78 | 3.16 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 2.02 | 2-Sided | 95 | 1.63 | 2.49 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 6.61 | 2-Sided | 95 | 4.31 | 10.15 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 4.92 | 2-Sided | 95 | 3.34 | 7.26 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 2.73 | 2-Sided | 95 | 2.08 | 3.57 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 2.82 | 2-Sided | 95 | 2.08 | 3.83 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 3.79 | 2-Sided | 95 | 2.80 | 5.13 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 1.32 | 2-Sided | 95 | 1.11 | 1.57 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 1.30 | 2-Sided | 95 | 1.05 | 1.61 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 2.04 | 2-Sided | 95 | 1.51 | 2.75 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 2.87 | 2-Sided | 95 | 2.19 | 3.77 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 1.95 | 2-Sided | 95 | 1.59 | 2.39 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
| 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. | geometric mean fold rise | 11.7 | 2-Sided | 95 | 5.20 | 26.10 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 156.4 | 2-Sided | 95 | 48.72 | 501.86 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 37.4 | 2-Sided | 95 | 13.71 | 102.31 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 93.9 | 2-Sided | 95 | 30.99 | 284.31 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 48.7 | 2-Sided | 95 | 23.27 | 101.97 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 32.1 | 2-Sided | 95 | 11.99 | 85.81 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 78.1 | 2-Sided | 95 | 50.42 | 120.94 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 10.3 | 2-Sided | 95 | 6.80 | 15.72 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 61.7 | 2-Sided | 95 | 32.75 | 116.34 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 536.5 | 2-Sided | 95 | 212.04 | 1357.19 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 116.9 | 2-Sided | 95 | 33.28 | 410.33 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 24.6 | 2-Sided | 95 | 11.30 | 53.42 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
| 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. | geometric mean fold rise | 40.3 | 2-Sided | 95 | 10.97 | 148.44 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 61.9 | 2-Sided | 95 | 18.83 | 203.72 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 26.7 | 2-Sided | 95 | 9.67 | 73.84 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 226.9 | 2-Sided | 95 | 79.81 | 645.29 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 116.8 | 2-Sided | 95 | 54.54 | 250.13 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 481.0 | 2-Sided | 95 | 207.01 | 1117.69 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 66.5 | 2-Sided | 95 | 41.80 | 105.75 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 8.6 | 2-Sided | 95 | 5.36 | 13.94 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 78.2 | 2-Sided | 95 | 41.38 | 147.80 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 438.1 | 2-Sided | 95 | 169.52 | 1132.43 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 80.0 | 2-Sided | 95 | 23.28 | 274.82 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 61.5 | 2-Sided | 95 | 28.73 | 131.76 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
| 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. | geometric mean fold rise | 7.6 | 2-Sided | 95 | 3.47 | 16.75 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 151.4 | 2-Sided | 95 | 42.01 | 545.84 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 23.7 | 2-Sided | 95 | 8.67 | 64.54 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 102.1 | 2-Sided | 95 | 32.00 | 325.40 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 31.1 | 2-Sided | 95 | 12.71 | 76.13 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 18.7 | 2-Sided | 95 | 6.82 | 51.39 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 64.4 | 2-Sided | 95 | 37.33 | 111.18 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 11.1 | 2-Sided | 95 | 6.64 | 18.52 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 41.2 | 2-Sided | 95 | 23.09 | 73.48 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 479.6 | 2-Sided | 95 | 171.63 | 1339.96 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 76.4 | 2-Sided | 95 | 21.63 | 270.02 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 17.7 | 2-Sided | 95 | 7.61 | 41.08 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
| 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. | geometric mean fold rise | 17.8 | 2-Sided | 95 | 5.27 | 59.91 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 67.8 | 2-Sided | 95 | 18.45 | 249.02 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 22.2 | 2-Sided | 95 | 7.94 | 61.88 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 205.5 | 2-Sided | 95 | 70.04 | 602.78 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 90.5 | 2-Sided | 95 | 40.28 | 203.27 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 91.7 | 2-Sided | 95 | 36.25 | 232.13 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 75.6 | 2-Sided | 95 | 47.32 | 120.91 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 8.7 | 2-Sided | 95 | 5.21 | 14.40 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 60.0 | 2-Sided | 95 | 31.06 | 115.92 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 269.8 | 2-Sided | 95 | 105.09 | 692.60 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 37.7 | 2-Sided | 95 | 10.85 | 131.09 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 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. | geometric mean fold rise | 44.8 | 2-Sided | 95 | 21.31 | 94.01 | CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise. | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). |
| ratio of geometric mean concentrations |
| 2.95 |
| 2-Sided |
| 95 |
| 1.78 |
| 4.90 |
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. |
| No |
| Superiority or Other |
| 7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.85 | 2-Sided | 95 | 1.25 | 2.75 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 2.24 | 2-Sided | 95 | 1.11 | 4.53 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 0.63 | 2-Sided | 95 | 0.38 | 1.05 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 0.90 | 2-Sided | 95 | 0.50 | 1.62 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 0.83 | 2-Sided | 95 | 0.48 | 1.43 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.70 | 2-Sided | 95 | 0.96 | 3.00 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.25 | 2-Sided | 95 | 0.79 | 1.96 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 0.90 | 2-Sided | 95 | 0.54 | 1.52 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.81 | 2-Sided | 95 | 0.98 | 3.34 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.72 | 2-Sided | 95 | 1.05 | 2.83 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.06 | 2-Sided | 95 | 0.67 | 1.66 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). |
| ratio of geometric mean concentrations |
| 3.13 |
| 2-Sided |
| 95 |
| 1.84 |
| 5.32 |
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. |
| No |
| Superiority or Other |
| 7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.68 | 2-Sided | 95 | 1.13 | 2.51 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.96 | 2-Sided | 95 | 0.95 | 4.07 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 0.90 | 2-Sided | 95 | 0.51 | 1.56 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.58 | 2-Sided | 95 | 0.93 | 2.66 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.62 | 2-Sided | 95 | 0.97 | 2.73 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.41 | 2-Sided | 95 | 0.83 | 2.39 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.44 | 2-Sided | 95 | 0.89 | 2.34 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.06 | 2-Sided | 95 | 0.68 | 1.64 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.88 | 2-Sided | 95 | 1.05 | 3.35 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.48 | 2-Sided | 95 | 0.90 | 2.44 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean concentrations | 1.11 | 2-Sided | 95 | 0.75 | 1.66 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). |
| ratio of geometric mean titers |
| 1.1 |
| 2-Sided |
| 95 |
| 0.70 |
| 1.73 |
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. |
| No |
| Superiority or Other |
| 7vPnC serotype 9V: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 0.8 | 2-Sided | 95 | 0.61 | 1.15 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 0.8 | 2-Sided | 95 | 0.56 | 1.25 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 0.8 | 2-Sided | 95 | 0.51 | 1.40 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 0.6 | 2-Sided | 95 | 0.32 | 1.12 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 0.6 | 2-Sided | 95 | 0.38 | 0.85 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 1.3 | 2-Sided | 95 | 0.75 | 2.22 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 1.1 | 2-Sided | 95 | 0.82 | 1.61 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 0.9 | 2-Sided | 95 | 0.36 | 2.13 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 0.9 | 2-Sided | 95 | 0.55 | 1.39 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 1.1 | 2-Sided | 95 | 0.73 | 1.70 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 0.9 | 2-Sided | 95 | 0.50 | 1.63 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). |
| ratio of geometric mean titers |
| 1.3 |
| 2-Sided |
| 95 |
| 0.77 |
| 2.05 |
CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. |
| No |
| Superiority or Other |
| 7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 0.9 | 2-Sided | 95 | 0.54 | 1.44 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 0.6 | 2-Sided | 95 | 0.38 | 0.95 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 1.1 | 2-Sided | 95 | 0.64 | 1.91 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 0.7 | 2-Sided | 95 | 0.28 | 1.62 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| 7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 1.4 | 2-Sided | 95 | 0.68 | 2.81 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 1.0 | 2-Sided | 95 | 0.53 | 1.77 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 1.1 | 2-Sided | 95 | 0.69 | 1.81 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 0.8 | 2-Sided | 95 | 0.32 | 1.85 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 1.4 | 2-Sided | 95 | 0.80 | 2.36 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 1.3 | 2-Sided | 95 | 0.65 | 2.44 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC). | ratio of geometric mean titers | 0.9 | 2-Sided | 95 | 0.46 | 1.57 | CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) - (MnCC/13vPnC)]. | No | Superiority or Other |
| Swelling: Any |
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Redness: Any |
|
| Redness: Mild |
|
| Redness: Moderate |
|
| Decreased appetite: Mild |
|
| Decreased appetite: Moderate |
|
| Irritability |
|
| Irritability: Mild |
|
| Irritability: Moderate |
|
| Increased sleep |
|
| Increased sleep: Mild |
|
| Increased sleep: Moderate |
|
| Increased sleep: Severe |
|
| Decreased sleep |
|
| Decreased sleep: Mild |
|
| Decreased sleep: Moderate |
|
| Rash |
|
| Rash: Mild |
|
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
| difference in proportions |
| 0.0 |
| 2-Sided |
| 95 |
| -10.0 |
| 10.1 |
| No |
| Superiority or Other |
| 7vPnC serotype 9V: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.4 | 10.3 | No | Superiority or Other |
| 7vPnC serotype 14: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.4 | 10.3 | No | Superiority or Other |
| 7vPnC serotype 18C: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.0 | No | Superiority or Other |
| 7vPnC serotype 19F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.4 | 10.3 | No | Superiority or Other |
| 7vPnC serotype 23F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -10.0 | 10.1 | No | Superiority or Other |
| Additional serotype 1: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.4 | 10.3 | No | Superiority or Other |
| Additional serotype 3: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.0 | No | Superiority or Other |
| Additional serotype 5: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 3.1 | 2-Sided | 95 | -9.3 | 17.0 | No | Superiority or Other |
| Additional serotype 6A: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.4 | 10.3 | No | Superiority or Other |
| Additional serotype 7F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -10.0 | 10.1 | No | Superiority or Other |
| Additional serotype 19A: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.0 | No | Superiority or Other |
| 7vPnC serotype 9V |
|
| 7vPnC serotype 14 |
|
| 7vPnC serotype 18C |
|
| 7vPnC serotype 19F |
|
| 7vPnC serotype 23F |
|
| Additional serotype 1 |
|
| Additional serotype 3 |
|
| Additional serotype 5 |
|
| Additional serotype 6A |
|
| Additional serotype 7F |
|
| Additional serotype 19A |
|
| difference in proportions |
| 0.0 |
| 2-Sided |
| 95 |
| -10.2 |
| 10.6 |
| No |
| Superiority or Other |
| 7vPnC serotype 9V: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.4 | 10.3 | No | Superiority or Other |
| 7vPnC serotype 14: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.3 | No | Superiority or Other |
| 7vPnC serotype 18C: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -10.0 | 10.1 | No | Superiority or Other |
| 7vPnC serotype 19F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -10.1 | 10.5 | No | Superiority or Other |
| 7vPnC serotype 23F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 3.0 | 2-Sided | 95 | -9.1 | 16.6 | No | Superiority or Other |
| Additional serotype 1: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -10.0 | 10.1 | No | Superiority or Other |
| Additional serotype 3: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.4 | 10.3 | No | Superiority or Other |
| Additional serotype 5: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 3.3 | 2-Sided | 95 | -8.6 | 17.2 | No | Superiority or Other |
| Additional serotype 6A: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.0 | No | Superiority or Other |
| Additional serotype 7F: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.7 | 10.6 | No | Superiority or Other |
| Additional serotype 19A: difference in proportions, [(7vPnC/13vPnC) - (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval. | difference in proportions | 0.0 | 2-Sided | 95 | -9.5 | 10.0 | No | Superiority or Other |