Immunogenicity, Vaccine
Conditions
Keywords
Serum concentrations of anticapsular immunoglobulin G (IgG) and serum levels of opsonophagocytic activity (OPA) for the PCV13 pneumococcal serotypes
Brief summary
This is a PAC study after PCV13 launch in China. Based on recommendation from China Agency, Pfizer was required to conduct a descriptive immunogenicity study to measure the antibody levels at the time of disease onset.
Interventions
BIOLOGICALPCV13 PAC study
To test the serotype-specific IgG geometric mean concentration (GMC) and MOPA geometric mean titers (GMT) for each of the pneumococcal serotypes measured at the time of diagnosis of clinical pneumonia.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Months to 60 Months
Healthy volunteers
No
Inclusion criteria
1. Evidence of a personally signed and dated informed consent document indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study. 2. Subjects whose caregiver is willing and able to comply with scheduled visits, laboratory tests, and other study procedures. 3. A diagnosis of clinical pneumonia per SCH standard of care. 4. 5 months to ≤60 months of age at the time of consent. 5. Vaccination history (ie, vaccine book or picture of vaccine book) is available for confirmation.
Exclusion criteria
1. Infant or child who is a family member of: * Investigator site staff members directly involved in the conduct of the study; * Site staff members otherwise supervised by the investigator; * Pfizer employees directly involved in the conduct of the study. 2. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 3. Blood draw is counter indicated. 4. Previous participation in this study within 30 days. 5. Previous vaccination with licensed or investigational pneumococcal vaccine. This excludes previous vaccination with 13vPnC as per the approved recommendations in China. 6. Received blood, blood fractions, plasma, or immunoglobulins within 3 months of the study blood draw. 7. Hospital acquired pneumonia (ie, onset \>48 hours after hospitalization).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Day 1 | Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by enzyme-linked immunosorbent assay (ELISA) for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all participants with a collected blood sample. |
| Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Day 1 | Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort participants with adequate blood volume. In the Non-13vPnC cohort, a sample of participants with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. Titer was expressed as reciprocal of the highest serum dilution. |
| GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Day 1 | Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by ELISA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all participants with a collected blood sample. For each cohort, participants were assigned to 2 subgroups: Participant in whom a 13vPnC VT strain had been isolated from the respiratory tract, and participant from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier). |
| GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Day 1 | Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort participants with adequate blood volume. In the Non-13vPnC cohort, a sample of participants with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. For each cohort, participants were assigned to 2 subgroups: Participant in whom a 13vPnC VT strain had been isolated from the respiratory tract, and participant from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier). Titer was expressed as reciprocal of the highest serum dilution. |
Countries
China
Participant flow
Recruitment details
Children hospitalized with a diagnosis of clinical pneumonia were considered for the study. Participants participated in the study for 1 day. Participants were followed for 12 hours after blood draw and deep respiratory aspirate if collected as a study procedure. A total of 300 participants were enrolled in this study.
Pre-assignment details
No vaccines were administered during the study.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Cohort The vaccination history of 13-valent pneumococcal conjugate vaccine (13vPnC) initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnc vaccination was confirmed as received, and all other inclusion/exclusion criteria were met, this participant was enrolled and assigned to the vaccinated group (ie, 13vPnC Cohort). No vaccines were administered during the study. | 101 |
| Non-13vPnC Cohort The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). No vaccines were administered during the study. | 199 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 7 | 16 |
Baseline characteristics
| Characteristic | 13vPnC Cohort | Total | Non-13vPnC Cohort |
|---|---|---|---|
| Age, Customized 13-24 months | 39 Participants | 88 Participants | 49 Participants |
| Age, Customized 25-60 months | 34 Participants | 134 Participants | 100 Participants |
| Age, Customized <=4 months | 1 Participants | 1 Participants | 0 Participants |
| Age, Customized 5-12 months | 27 Participants | 77 Participants | 50 Participants |
| Race/Ethnicity, Customized Ethnicity Non-Hispanic/non-Latino | 101 Participants | 300 Participants | 199 Participants |
| Race/Ethnicity, Customized Race Asian | 101 Participants | 300 Participants | 199 Participants |
| Sex: Female, Male Female | 48 Participants | 142 Participants | 94 Participants |
| Sex: Female, Male Male | 53 Participants | 158 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 199 |
| other Total, other adverse events | 0 / 101 | 0 / 199 |
| serious Total, serious adverse events | 0 / 101 | 0 / 199 |
Outcome results
Primary
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by enzyme-linked immunosorbent assay (ELISA) for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all participants with a collected blood sample.
Time frame: Day 1
Population: Analysis population for this outcome measure (OM) included all participants who signed the informed consent document, met all inclusion/exclusion criteria, and had at least 1 immunogenicity assay value available for analysis. Overall number of participants analyzed indicates the number of participants in this analysis population. Number Analyzed in each row indicates the number of participants with valid and determinate assay results for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 4 | 1.36 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 9V | 1.18 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 6A | 2.42 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 14 | 4.67 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 3 | 0.42 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 18C | 1.03 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 6B | 2.47 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 19A | 3.19 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 5 | 1.74 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 19F | 3.31 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 7F | 1.81 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 23F | 2.04 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 1 | 1.55 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 23F | 0.25 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 1 | 0.12 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 3 | 0.07 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 4 | 0.08 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 5 | 0.72 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 6A | 0.38 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 6B | 0.37 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 7F | 0.19 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 9V | 0.30 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 14 | 0.08 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 18C | 0.06 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 19A | 0.75 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Serotype: 19F | 0.38 microgram per milliliter (µg/mL) |
Comparison: Geometric mean ratio (GMR) of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 195% CI: [8.99, 19.28]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 395% CI: [4.32, 8.01]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 495% CI: [12.07, 26.78]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 595% CI: [1.9, 3.08]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6A95% CI: [4.68, 8.61]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6B95% CI: [4.92, 8.97]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 7F95% CI: [6.91, 12.83]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 9V95% CI: [2.96, 5.1]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 1495% CI: [40.16, 96.12]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 18C95% CI: [11.22, 23.89]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19A95% CI: [3.22, 5.62]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19F95% CI: [6.24, 12.21]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 23F95% CI: [6.15, 11.29]
Primary
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort participants with adequate blood volume. In the Non-13vPnC cohort, a sample of participants with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. Titer was expressed as reciprocal of the highest serum dilution.
Time frame: Day 1
Population: Analysis population for this OM included all participants who signed the informed consent document, met all inclusion/exclusion criteria, and had at least 1 immunogenicity assay value available for analysis. Overall number of participants analyzed indicates the number of participants in this analysis population. Number Analyzed in each row indicates the number of participants with valid and determinate assay results for the specified serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 4 | 1148.4 Titers |
| 13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 9V | 919.7 Titers |
| 13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 6A | 1825.9 Titers |
| 13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 14 | 1387.9 Titers |
| 13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 3 | 272.8 Titers |
| 13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 18C | 404.2 Titers |
| 13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 6B | 844.8 Titers |
| 13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 19A | 1046.6 Titers |
| 13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 5 | 326.5 Titers |
| 13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 19F | 554.2 Titers |
| 13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 7F | 3791.4 Titers |
| 13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 23F | 3634.9 Titers |
| 13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 1 | 70.9 Titers |
| Non-13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 23F | 81.8 Titers |
| Non-13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 1 | 14.8 Titers |
| Non-13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 5 | 18.1 Titers |
| Non-13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 3 | 30.1 Titers |
| Non-13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 4 | 79.9 Titers |
| Non-13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 6A | 53.9 Titers |
| Non-13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 6B | 60.1 Titers |
| Non-13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 7F | 223.2 Titers |
| Non-13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 9V | 47.6 Titers |
| Non-13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 14 | 132.7 Titers |
| Non-13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 18C | 33.3 Titers |
| Non-13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 19A | 44.3 Titers |
| Non-13vPnC Cohort | Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Serotype: 19F | 31.4 Titers |
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 195% CI: [2.32, 9.86]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 395% CI: [4.72, 17.39]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 495% CI: [6.25, 33.05]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 595% CI: [8.84, 36.8]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6A95% CI: [14.33, 80.13]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6B95% CI: [6.07, 32.52]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 7F95% CI: [7.85, 36.76]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 9V95% CI: [9.13, 40.84]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 1495% CI: [4.74, 23.1]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 18C95% CI: [6, 24.51]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19A95% CI: [10.94, 51.1]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19F95% CI: [8.65, 35.93]
Comparison: GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 23F95% CI: [19.11, 103.43]
Primary
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by ELISA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all participants with a collected blood sample. For each cohort, participants were assigned to 2 subgroups: Participant in whom a 13vPnC VT strain had been isolated from the respiratory tract, and participant from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier).
Time frame: Day 1
Population: Analysis population for this OM included all participants who signed the informed consent document, met all inclusion/exclusion criteria, and had at least 1 immunogenicity assay value available for analysis. Overall number of participants analyzed indicates the number of participants in this analysis population. Number Analyzed in each row indicates the number of participants with valid and determinate assay results for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 14 | 3.29 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 1 | 0.81 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 9V | 0.97 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 23F | 1.04 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 18C | 0.65 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 3 | 0.32 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 19A | 4.69 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 7F | 0.83 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 4 | 0.97 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 19F | 5.80 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 6B | 1.94 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 6A | 1.78 microgram per milliliter (µg/mL) |
| 13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 5 | 1.45 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 5 | 1.77 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 6A | 2.59 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 6B | 2.60 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 14 | 4.96 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 18C | 1.08 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 19A | 3.02 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 23F | 2.23 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 19F | 3.22 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 1 | 1.69 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 3 | 0.44 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 4 | 1.43 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 7F | 1.97 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 9V | 1.21 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT+ Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 9V | 0.22 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT+ Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 23F | 0.25 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT+ Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 1 | 0.08 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT+ Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 3 | 0.05 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT+ Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 4 | 0.05 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT+ Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 5 | 0.58 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT+ Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 6A | 0.34 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT+ Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 6B | 0.51 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT+ Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 7F | 0.14 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT+ Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 14 | 0.04 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT+ Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 18C | 0.04 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT+ Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 19A | 0.58 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT+ Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 19F | 0.38 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 23F | 0.23 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 1 | 0.12 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 18C | 0.06 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 19F | 0.33 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 14 | 0.08 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 6A | 0.36 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 19A | 0.74 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 3 | 0.07 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 6B | 0.33 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 7F | 0.19 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 5 | 0.72 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 4 | 0.07 microgram per milliliter (µg/mL) |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Serotype: 9V | 0.30 microgram per milliliter (µg/mL) |
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 195% CI: [0.16, 1.42]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 395% CI: [0.27, 1.98]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 495% CI: [0.21, 2.19]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 595% CI: [0.36, 1.86]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6A95% CI: [0.25, 1.89]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6B95% CI: [0.27, 2.07]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 7F95% CI: [0.16, 1.09]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 9V95% CI: [0.35, 1.81]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 1495% CI: [0.2, 2.24]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 18C95% CI: [0.22, 1.65]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19A95% CI: [0.61, 3.93]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19F95% CI: [0.65, 4.99]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 23F95% CI: [0.17, 1.31]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 195% CI: [0.31, 1.38]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 395% CI: [0.4, 1.24]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 495% CI: [0.33, 1.59]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 595% CI: [0.52, 1.25]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6A95% CI: [0.57, 1.52]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6B95% CI: [0.95, 2.47]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 7F95% CI: [0.41, 1.34]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 9V95% CI: [0.34, 1.57]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 1495% CI: [0.16, 1.18]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 18C95% CI: [0.25, 1.4]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19A95% CI: [0.5, 1.23]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19F95% CI: [0.6, 2.18]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 23F95% CI: [0.68, 1.72]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 195% CI: [2.44, 43.49]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 395% CI: [2.07, 18.42]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 495% CI: [4.35, 80.37]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 595% CI: [1.14, 5.52]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6A95% CI: [2.33, 11.8]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6B95% CI: [1.47, 9.65]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 7F95% CI: [1.65, 21.36]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 9V95% CI: [1.17, 16.87]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 1495% CI: [16.67, 494.56]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 18C95% CI: [3.79, 83.78]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19A95% CI: [3.6, 18.3]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19F95% CI: [4.64, 50.35]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 23F95% CI: [1.72, 10.25]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 195% CI: [9.14, 21.23]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 395% CI: [4.17, 8.24]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 495% CI: [12.8, 31.15]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 595% CI: [1.87, 3.24]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6A95% CI: [5.05, 10.03]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6B95% CI: [5.54, 10.92]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 7F95% CI: [7.4, 14.61]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 9V95% CI: [3.04, 5.47]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 1495% CI: [37.25, 97.67]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 18C95% CI: [11.37, 26.47]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19A95% CI: [3, 5.62]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19F95% CI: [6.65, 14.08]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 23F95% CI: [6.9, 13.64]
Primary
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort participants with adequate blood volume. In the Non-13vPnC cohort, a sample of participants with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. For each cohort, participants were assigned to 2 subgroups: Participant in whom a 13vPnC VT strain had been isolated from the respiratory tract, and participant from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier). Titer was expressed as reciprocal of the highest serum dilution.
Time frame: Day 1
Population: Analysis population for this OM included all participants who signed the informed consent document, met all inclusion/exclusion criteria, and had at least 1 immunogenicity assay value available for analysis. Overall number of participants analyzed indicates the number of participants in this analysis population. Number Analyzed in each row indicates the number of participants with valid and determinate assay results for the specified serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 19A | 1515.6 Titers |
| 13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 6B | 69.4 Titers |
| 13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 1 | 35.0 Titers |
| 13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 18C | 364.1 Titers |
| 13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 9V | 215.9 Titers |
| 13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 14 | 578.9 Titers |
| 13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 3 | 146.6 Titers |
| 13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 23F | 1092.5 Titers |
| 13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 4 | 522.0 Titers |
| 13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 19F | 1830.0 Titers |
| 13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 5 | 539.5 Titers |
| 13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 6A | 482.4 Titers |
| 13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 7F | 4661.3 Titers |
| Non-13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 14 | 1617.3 Titers |
| Non-13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 5 | 302.7 Titers |
| Non-13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 6B | 1099.1 Titers |
| Non-13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 19F | 472.7 Titers |
| Non-13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 18C | 443.2 Titers |
| Non-13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 1 | 71.1 Titers |
| Non-13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 4 | 1154.4 Titers |
| Non-13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 7F | 3837.7 Titers |
| Non-13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 9V | 1074.9 Titers |
| Non-13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 19A | 1122.7 Titers |
| Non-13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 23F | 4111.0 Titers |
| Non-13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 6A | 2110.3 Titers |
| Non-13vPnC Cohort | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 3 | 273.7 Titers |
| Non-13vPnC Cohort: VT+ Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 23F | 104.1 Titers |
| Non-13vPnC Cohort: VT+ Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 14 | 289.1 Titers |
| Non-13vPnC Cohort: VT+ Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 1 | 11.1 Titers |
| Non-13vPnC Cohort: VT+ Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 3 | 29.2 Titers |
| Non-13vPnC Cohort: VT+ Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 4 | 38.1 Titers |
| Non-13vPnC Cohort: VT+ Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 5 | 11.1 Titers |
| Non-13vPnC Cohort: VT+ Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 6A | 46.1 Titers |
| Non-13vPnC Cohort: VT+ Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 6B | 102.7 Titers |
| Non-13vPnC Cohort: VT+ Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 7F | 442.5 Titers |
| Non-13vPnC Cohort: VT+ Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 9V | 65.0 Titers |
| Non-13vPnC Cohort: VT+ Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 18C | 22.3 Titers |
| Non-13vPnC Cohort: VT+ Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 19A | 62.7 Titers |
| Non-13vPnC Cohort: VT+ Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 19F | 19.3 Titers |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 6B | 53.9 Titers |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 3 | 28.6 Titers |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 18C | 34.4 Titers |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 6A | 52.5 Titers |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 5 | 17.6 Titers |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 1 | 14.6 Titers |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 19A | 41.6 Titers |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 4 | 86.1 Titers |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 23F | 84.4 Titers |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 19F | 30.4 Titers |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 9V | 45.3 Titers |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 14 | 125.9 Titers |
| Non-13vPnC Cohort: VT- or Sp- Subgroup | GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Serotype: 7F | 180.8 Titers |
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 195% CI: [0.06, 3.91]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 395% CI: [0.1, 2.92]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 495% CI: [0.1, 2.07]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 595% CI: [0.27, 11.75]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6A95% CI: [0.03, 1.65]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6B95% CI: [0.01, 0.44]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 7F95% CI: [0.56, 2.65]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 9V95% CI: [0.03, 1.26]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 1495% CI: [0.08, 1.55]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 18C95% CI: [0.15, 4.47]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19A95% CI: [0.19, 9.44]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19F95% CI: [0.67, 22.42]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 23F95% CI: [0.05, 1.52]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 195% CI: [0.19, 3.07]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 395% CI: [0.42, 2.46]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 495% CI: [0.05, 3.73]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 595% CI: [0.15, 2.73]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6A95% CI: [0.11, 6.99]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6B95% CI: [0.29, 12.51]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 7F95% CI: [0.34, 17.43]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 9V95% CI: [0.27, 7.7]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 1495% CI: [0.3, 17.41]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 18C95% CI: [0.14, 2.97]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19A95% CI: [0.28, 8.21]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19F95% CI: [0.13, 2.97]
Comparison: GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 23F95% CI: [0.15, 10.24]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 195% CI: [0.41, 23.91]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 395% CI: [1.45, 17.39]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 495% CI: [1.32, 141.81]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 595% CI: [6.16, 380.54]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6A95% CI: [0.48, 229.1]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6B95% CI: [0.02, 19.83]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 7F95% CI: [1.98, 55.96]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 9V95% CI: [0.19, 56.82]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 1495% CI: [0.06, 63.12]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 18C95% CI: [2.15, 123.48]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19A95% CI: [1.59, 367.81]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19F95% CI: [13.08, 691.01]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 23F95% CI: [0.64, 171.84]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 195% CI: [2.15, 10.96]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 395% CI: [4.5, 20.36]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 495% CI: [5.2, 34.51]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 595% CI: [7.76, 37.91]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6A95% CI: [15.16, 106.65]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6B95% CI: [8.39, 49.51]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 7F95% CI: [8.65, 52.07]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 9V95% CI: [10.39, 54.19]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 1495% CI: [5.46, 30.22]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 18C95% CI: [5.95, 27.88]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19A95% CI: [11.46, 63.58]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19F95% CI: [7.02, 34.38]
Comparison: GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 23F95% CI: [18.67, 127.16]