Pneumococcal Disease
Conditions
Brief summary
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve Japanese adults 65 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23 and the cross-reactive serotype 15B in V116, and that the immunogenicity of V116 is superior to PPSV23 for the unique serotype 15C in V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in the 8 unique V116 serotypes (except for 15C), as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).
Interventions
BIOLOGICALV116
Sterile 0.5 mL solution in prefilled syringe containing 4 μg of each pneumococcal polysaccharide (PnPs) antigen 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.
BIOLOGICALPPSV23
Sterile 0.5 mL solution in prefilled syringe containing 25 μg of each PnPs antigen 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Is Japanese * For females, is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) or is a POCBP and uses acceptable contraception/abstinence; has a negative highly sensitive pregnancy test (urine or serum) within 24 (urine) or 72 (serum) hours before the first dose of study intervention; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of inclusion of an early undetected pregnancy
Exclusion criteria
* Has a history of invasive pneumococcal disease (IPD) \[positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site\] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1) * Has a known hypersensitivity to any component of V116 or PPSV23, including diphtheria toxoid * Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease * Has a coagulation disorder contraindicating IM vaccination * Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F \[≥38.0°C\] or axillary or temporal temperature ≥99.4°F \[≥37.4°C\]) or received antibiotic therapy for any acute illness occurring \<72 hours before receipt of study vaccine * Has a known malignancy that is progressing or has required active treatment \<3 years before enrollment * Received prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol * Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine * Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease * Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable) * Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine * Received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 postvaccination blood draw is complete
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Up to 5 days postvaccination | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. |
| Percentage of Participants With Solicited Systemic AEs | Up to 5 days postvaccination | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited systemic AEs were muscle pain/myalgia, headache, and tiredness/fatigue. |
| Percentage of Participants With Vaccine-related Serious AEs (SAEs) | Up to 30 days postvaccination | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were summarized. |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30 postvaccination | The serotype-specific OPA GMTs for the 12 common serotypes contained in V116 and PPSV23, the unique serotype 15C in V116, and the cross-reactive serotype 15B were determined using the multiplex opsonophagocytic assay (MOPA). |
| Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Baseline (Day 1) and Day 30 postvaccination | The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the 8 unique serotypes contained in V116 (except for 15C) were determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific OPA GMTs (Unique Serotypes) | Day 30 postvaccination | The serotype-specific OPA GMTs for the 8 unique serotypes contained in V116 (except for serotype 15C) and the cross-reactive serotype 6C in V116 were determined using MOPA. |
| Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Baseline (Day 1) and Day 30 postvaccination | Activity for the serotypes contained in V116 and PPSV23 were determined using PnECL. The percentage of participants who had ≥4-fold rise in IgG titers were calculated from baseline to postvaccination. |
| Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Day 30 postvaccination | The GMCs for serotype-specific IgG antibodies were determined using pneumococcal electrochemiluminescence (PnECL). |
| Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Baseline (Day 1) and Day 30 postvaccination | The GMFR from baseline in serotype-specific OPA GMTs was determined using MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. |
| Serotype-specific GMFR in IgG GMCs | Baseline (Day 1) and Day 30 postvaccination | The GMFR from baseline in GMCs for serotype-specific IgG antibodies was determined using PnECL. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. |
| Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Baseline (Day 1) and Day 30 postvaccination | Activity for the serotypes contained in V116 and PPSV23 were determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| V116 Participants receive a single intramuscular (IM) injection of V116 on Day 1. | 225 |
| PPSV23 Participants receive a single IM injection of PPSV23 on Day 1. | 225 |
| Total | 450 |
Baseline characteristics
| Characteristic | PPSV23 | Total | V116 |
|---|---|---|---|
| Age, Continuous | 70.9 Years STANDARD_DEVIATION 5.6 | 70.9 Years STANDARD_DEVIATION 5.7 | 70.9 Years STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 225 Participants | 450 Participants | 225 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Serotype 15A | 416.4 Titers | 401.3 Titers | 387.0 Titers |
| Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Serotype 16F | 757.9 Titers | 787.8 Titers | 820.5 Titers |
| Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Serotype 23A | 344.8 Titers | 333.9 Titers | 324.0 Titers |
| Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Serotype 23B | 41.2 Titers | 38.9 Titers | 36.6 Titers |
| Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Serotype 24F | 641.9 Titers | 634.6 Titers | 627.6 Titers |
| Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Serotype 31 | 176.5 Titers | 151.0 Titers | 129.0 Titers |
| Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Serotype 35B | 937.0 Titers | 893.7 Titers | 852.6 Titers |
| Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Serotype 6A | 149.1 Titers | 127.9 Titers | 108.5 Titers |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 225 Participants | 450 Participants | 225 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 96 Participants | 195 Participants | 99 Participants |
| Sex: Female, Male Male | 129 Participants | 255 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 225 | 0 / 225 |
| other Total, other adverse events | 77 / 225 | 96 / 225 |
| serious Total, serious adverse events | 1 / 225 | 0 / 225 |
Outcome results
Primary
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)
The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the 8 unique serotypes contained in V116 (except for 15C) were determined.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Population: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 6A | 72.8 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 15A | 59.7 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 16F | 50.3 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 23A | 57.6 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 23B | 82.1 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 24F | 42.9 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 31 | 70.3 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 35B | 52.9 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 35B | 6.0 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 6A | 45.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 23B | 43.7 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 15A | 26.0 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 31 | 13.1 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 16F | 11.9 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 24F | 16.0 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116) | Serotype 23A | 27.9 Percentage of Participants |
Comparison: Serotype 6Ap-value: <0.00195% CI: [17.8, 36.9]Stratified Miettinen & Nurminen
Comparison: Serotype 15Ap-value: <0.00195% CI: [23.6, 43]Stratified Miettinen & Nurminen
Comparison: Serotype 16Fp-value: <0.00195% CI: [29.8, 46.4]Stratified Miettinen & Nurminen
Comparison: Serotype 23Ap-value: <0.00195% CI: [17.4, 40.6]Stratified Miettinen & Nurminen
Comparison: Serotype 23Bp-value: <0.00195% CI: [29.3, 46.7]Stratified Miettinen & Nurminen
Comparison: Serotype 24Fp-value: <0.00195% CI: [18.3, 35.6]Stratified Miettinen & Nurminen
Comparison: Serotype 31p-value: <0.00195% CI: [49.3, 64.4]Stratified Miettinen & Nurminen
Comparison: Serotype 35Bp-value: <0.00195% CI: [39.5, 54.1]Stratified Miettinen & Nurminen
Primary
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Time frame: Up to 5 days postvaccination
Population: The analysis population includes all participants who received ≥1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | 32.9 Percentage of participants |
| PPSV23 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | 39.1 Percentage of participants |
Primary
Percentage of Participants With Solicited Systemic AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited systemic AEs were muscle pain/myalgia, headache, and tiredness/fatigue.
Time frame: Up to 5 days postvaccination
Population: The analysis population includes all participants who received ≥1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V116 | Percentage of Participants With Solicited Systemic AEs | 17.3 Percentage of participants |
| PPSV23 | Percentage of Participants With Solicited Systemic AEs | 16.4 Percentage of participants |
Primary
Percentage of Participants With Vaccine-related Serious AEs (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were summarized.
Time frame: Up to 30 days postvaccination
Population: The analysis population includes all participants who received ≥1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V116 | Percentage of Participants With Vaccine-related Serious AEs (SAEs) | 0.0 Percentage of participants |
| PPSV23 | Percentage of Participants With Vaccine-related Serious AEs (SAEs) | 0.0 Percentage of participants |
Primary
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
The serotype-specific OPA GMTs for the 12 common serotypes contained in V116 and PPSV23, the unique serotype 15C in V116, and the cross-reactive serotype 15B were determined using the multiplex opsonophagocytic assay (MOPA).
Time frame: Day 30 postvaccination
Population: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 3 | 14.2 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 10A | 1591.2 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 7F | 243.9 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 19A | 1338.4 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 8 | 48.8 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 7F | 2675.1 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 9N | 383.1 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 20A | 2617.2 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 10A | 131.5 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 11A | 1269.6 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 11A | 75.2 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 22F | 1830.9 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 12F | 18.1 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 9N | 2844.8 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 17F | 285.8 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 33F | 7692.4 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 19A | 188.1 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 12F | 968.5 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 20A | 460.0 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 15C | 2488.5 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 22F | 179.9 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 8 | 1293.3 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 33F | 1236.7 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 15B | 2081.1 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 15C | 110.0 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 17F | 3138.1 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 15B | 243.3 Titers |
| V116 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 3 | 155.1 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 15B | 251.7 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 3 | 170.8 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 7F | 2411.4 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 8 | 1142.4 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 9N | 2710.5 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 10A | 880.2 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 11A | 887.9 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 12F | 503.7 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 17F | 1860.3 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 19A | 1140.7 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 20A | 1731.5 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 22F | 1295.5 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 33F | 8610.8 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 15C | 1185.0 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Day 30, Serotype 15B | 1479.7 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 3 | 14.9 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 7F | 217.6 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 8 | 46.3 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 9N | 383.2 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 10A | 103.5 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 11A | 91.2 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 12F | 19.2 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 17F | 226.8 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 19A | 179.7 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 20A | 421.1 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 22F | 167.9 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 33F | 1198.9 Titers |
| PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) | Baseline, Serotype 15C | 102.6 Titers |
Comparison: Serotype 3p-value: <0.00195% CI: [0.75, 1.17]Constrained Longitudinal Data Analysis
Comparison: Serotype 7Fp-value: <0.00195% CI: [0.88, 1.33]Constrained Longitudinal Data Analysis
Comparison: Serotype 8p-value: <0.00195% CI: [0.93, 1.36]Constrained Longitudinal Data Analysis
Comparison: Serotype 9Np-value: <0.00195% CI: [0.86, 1.29]Constrained Longitudinal Data Analysis
Comparison: Serotype 10Ap-value: <0.00195% CI: [1.28, 2.14]Constrained Longitudinal Data Analysis
Comparison: Serotype 11Ap-value: <0.00195% CI: [1.2, 1.92]Constrained Longitudinal Data Analysis
Comparison: Serotype 12Fp-value: <0.00195% CI: [1.43, 2.72]Constrained Longitudinal Data Analysis
Comparison: Serotype 17Fp-value: <0.00195% CI: [1.28, 2]Constrained Longitudinal Data Analysis
Comparison: Serotype 19Ap-value: <0.00195% CI: [0.93, 1.45]Constrained Longitudinal Data Analysis
Comparison: Serotype 20Ap-value: <0.00195% CI: [1.18, 1.77]Constrained Longitudinal Data Analysis
Comparison: Serotype 22Fp-value: <0.00195% CI: [1.1, 1.76]Constrained Longitudinal Data Analysis
Comparison: Serotype 33Fp-value: <0.00195% CI: [0.68, 1.12]Constrained Longitudinal Data Analysis
Comparison: Serotype 15Bp-value: <0.00195% CI: [1.07, 1.89]Constrained Longitudinal Data Analysis
Comparison: Serotype 15Cp-value: <0.00195% CI: [1.56, 2.7]Constrained Longitudinal Data Analysis
Secondary
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Activity for the serotypes contained in V116 and PPSV23 were determined using PnECL. The percentage of participants who had ≥4-fold rise in IgG titers were calculated from baseline to postvaccination.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Population: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 3 | 56.4 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 7F | 77.8 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 8 | 78.7 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 9N | 72.9 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 10A | 79.1 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 11A | 69.3 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 12F | 73.3 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 17F | 82.7 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 19A | 49.3 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 20A | 75.1 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 22F | 71.6 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 33F | 71.6 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 6A | 76.4 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 15A | 80.9 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 15C | 77.8 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 16F | 80.4 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 23A | 76.9 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 23B | 72.9 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 24F | 87.6 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 31 | 75.6 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 35B | 84.0 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 6C | 29.8 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 15B | 60.4 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 33F | 73.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 3 | 59.6 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 23B | 35.6 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 7F | 70.7 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 6A | 45.8 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 8 | 78.7 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 35B | 0.9 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 9N | 75.1 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 15A | 27.6 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 10A | 61.8 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 24F | 0.0 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 11A | 44.9 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 15C | 61.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 12F | 56.9 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 15B | 65.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 17F | 69.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 16F | 8.0 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 19A | 47.1 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 31 | 7.6 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 20A | 59.6 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 23A | 14.7 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 22F | 56.9 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes) | Serotype 6C | 6.7 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Activity for the serotypes contained in V116 and PPSV23 were determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Population: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 3 | 73.8 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 7F | 68.5 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 8 | 79.8 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 9N | 57.6 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 10A | 69.3 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 11A | 69.3 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 12F | 84.3 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 17F | 66.1 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 19A | 58.1 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 20A | 54.1 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 22F | 62.0 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 33F | 58.0 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 6A | 72.8 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 15A | 59.7 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 15C | 81.0 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 16F | 50.3 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 23A | 57.6 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 23B | 82.1 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 24F | 42.9 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 31 | 70.3 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 35B | 52.9 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 6C | 34.2 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 15B | 67.2 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 33F | 63.7 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 3 | 71.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 23B | 43.7 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 7F | 69.6 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 6A | 45.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 8 | 81.0 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 35B | 6.0 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 9N | 58.8 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 15A | 26.0 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 10A | 59.7 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 24F | 16.0 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 11A | 55.8 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 15C | 65.4 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 12F | 74.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 15B | 54.6 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 17F | 62.6 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 16F | 11.9 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 19A | 61.0 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 31 | 13.1 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 20A | 42.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 23A | 27.9 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 22F | 52.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes) | Serotype 6C | 25.4 Percentage of Participants |
Secondary
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
The GMFR from baseline in serotype-specific OPA GMTs was determined using MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Population: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 3 | 7.2 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 33F | 6.4 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 11A | 13.6 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 6A | 9.4 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 8 | 20.6 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 15A | 6.7 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 12F | 32.2 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 15C | 19.1 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 16F | 4.7 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 23A | 5.9 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 17F | 9.8 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 23B | 26.2 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 9N | 6.9 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 24F | 3.8 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 19A | 6.7 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 31 | 13.6 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 7F | 10.0 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 35B | 5.5 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 20A | 5.6 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 6C | 2.9 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 10A | 10.1 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 15B | 7.4 Ratio |
| V116 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 22F | 8.9 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 15B | 4.8 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 3 | 7.2 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 7F | 9.8 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 8 | 19.1 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 9N | 6.6 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 10A | 7.6 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 11A | 7.3 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 12F | 17.1 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 17F | 7.1 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 19A | 5.8 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 20A | 4.1 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 22F | 6.9 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 33F | 7.3 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 6A | 3.7 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 15A | 2.0 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 16F | 1.5 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 23A | 1.8 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 23B | 4.2 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 24F | 1.5 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 31 | 1.4 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 35B | 1.2 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 6C | 2.0 Ratio |
| PPSV23 | Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT | Serotype 15C | 9.3 Ratio |
Secondary
Serotype-specific GMFR in IgG GMCs
The GMFR from baseline in GMCs for serotype-specific IgG antibodies was determined using PnECL. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Population: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 33F | 8.7 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 6A | 10.4 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 7F | 12.1 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 15A | 14.0 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 12F | 11.9 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 15C | 14.3 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 9N | 11.8 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 16F | 12.8 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 17F | 12.9 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 23A | 12.0 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 3 | 5.0 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 23B | 8.6 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 19A | 5.1 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 24F | 18.0 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 10A | 11.4 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 31 | 9.1 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 20A | 9.5 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 35B | 12.7 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 8 | 11.6 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 6C | 2.7 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 22F | 10.7 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 15B | 6.8 Ratio |
| V116 | Serotype-specific GMFR in IgG GMCs | Serotype 11A | 8.0 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 15B | 7.3 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 3 | 5.1 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 7F | 8.3 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 8 | 9.8 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 9N | 9.8 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 10A | 6.4 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 11A | 3.9 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 12F | 6.3 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 17F | 7.0 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 19A | 4.2 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 20A | 6.2 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 22F | 5.7 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 6A | 4.1 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 15A | 2.7 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 15C | 6.9 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 16F | 1.6 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 23A | 2.0 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 23B | 3.1 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 24F | 1.1 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 31 | 1.5 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 35B | 1.1 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 6C | 1.3 Ratio |
| PPSV23 | Serotype-specific GMFR in IgG GMCs | Serotype 33F | 7.7 Ratio |
Secondary
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
The GMCs for serotype-specific IgG antibodies were determined using pneumococcal electrochemiluminescence (PnECL).
Time frame: Day 30 postvaccination
Population: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 3 | 0.54 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 7F | 6.12 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 8 | 8.13 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 9N | 7.49 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 10A | 8.21 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 11A | 6.00 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 12F | 1.55 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 17F | 10.48 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 19A | 5.70 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 20A | 15.61 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 22F | 2.84 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 33F | 13.93 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 6A | 3.42 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 15A | 9.98 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 15C | 9.87 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 16F | 3.07 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 23A | 2.00 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 23B | 4.22 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 24F | 7.79 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 31 | 2.57 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 35B | 14.19 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 6C | 1.19 µg/mL |
| V116 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 15B | 10.15 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 33F | 12.67 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 3 | 0.58 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 23B | 1.65 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 7F | 4.25 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 6A | 1.64 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 8 | 6.72 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 35B | 1.38 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 9N | 5.44 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 15A | 1.64 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 10A | 3.84 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 24F | 0.41 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 11A | 3.02 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 15C | 4.55 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 12F | 0.66 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 15B | 9.86 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 17F | 5.08 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 16F | 0.37 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 19A | 4.87 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 31 | 0.40 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 20A | 9.78 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 23A | 0.32 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 22F | 1.39 µg/mL |
| PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Serotype 6C | 0.50 µg/mL |
Secondary
Serotype-specific OPA GMTs (Unique Serotypes)
The serotype-specific OPA GMTs for the 8 unique serotypes contained in V116 (except for serotype 15C) and the cross-reactive serotype 6C in V116 were determined using MOPA.
Time frame: Day 30 postvaccination
Population: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 6A | 1263.8 Titers |
| V116 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 15A | 2752.3 Titers |
| V116 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 16F | 4094.8 Titers |
| V116 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 23A | 2107.5 Titers |
| V116 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 23B | 1359.0 Titers |
| V116 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 24F | 2521.9 Titers |
| V116 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 31 | 2095.4 Titers |
| V116 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 35B | 4758.1 Titers |
| PPSV23 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 35B | 1051.4 Titers |
| PPSV23 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 6A | 641.8 Titers |
| PPSV23 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 23B | 202.2 Titers |
| PPSV23 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 15A | 832.2 Titers |
| PPSV23 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 31 | 260.7 Titers |
| PPSV23 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 16F | 1183.9 Titers |
| PPSV23 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 24F | 1043.8 Titers |
| PPSV23 | Serotype-specific OPA GMTs (Unique Serotypes) | Serotype 23A | 729.2 Titers |