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 adults 50 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 that V116 is superior to PPSV23 for the 9 serotypes unique to V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in unique V116 serotypes, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).
Detailed description
Selected participants may be eligible for optional immunogenicity or PBMC substudies extension that will investigate the exploratory objectives.
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
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; 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. Solicited injection-site AEs consisted of pain/tenderness, redness/erythema, and swelling. 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method. |
| 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. Solicited systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature ≥ 100.4 °F/38.0 °C). 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method. |
| Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) | Up to 6 months 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 an other important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination are summarized. 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method. |
| Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | Day 30 postvaccination | Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs), and they hypothesis test (1-sided p-value), were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated. |
| Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes 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 unique pneumococcal serotypes contained in V116 was determined. The 9 unique pneumococcal serotypes in V116 are as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific Cross-Reactive OPAs | Baseline (Day 1) and Day 30 postvaccination | OPA induced by serotypes 6A and 15C in V116 but cross-reactive to serotypes 6C and 15B, respectively, were measured. The percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs was determined. Point estimate, 95% CI, and p-value are based on the Clopper-Pearson method. Per protocol, this outcome measure was not planned or analyzed in the PPSV23 study arm. |
| Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | Baseline (Day 1) and Day 30 postvaccination | The GMFR from baseline in serotype-specific OPA GMTs for all serotypes in V116 was determined using MOPA. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. |
| Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | Day 30 postvaccination | The GMCs for serotype-specific IgG antibodies for all serotypes in V116 were determined using pneumococcal electrochemiluminescence (PnECL). The GMC ratio estimation and 95% CI were calculated using a cLDA method. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated. |
| Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | Baseline (Day 1) and Day 30 postvaccination | The GMFR from baseline in GMCs for serotype-specific IgG antibodies for all serotypes in V116 was determined using PnECL. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. |
| Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | Baseline (Day 1) and Day 30 postvaccination | The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs for all serotypes in V116 was determined with MOPA. The within-group CIs were calculated based on the Clopper-Pearson method. |
| Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | Baseline (Day 1) and Day 30 postvaccination | The percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs for all serotypes in V116 was determined using PnECL. The within-group CIs were calculated based on the Clopper-Pearson method. |
Countries
Argentina, Australia, Colombia, Germany, Israel, New Zealand, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Participant flow
Pre-assignment details
1484 participants were randomized in the base study. Additionally, a subgroup of the first 700 participants randomized in the base study to either V116 or PPSV23 were followed for an additional 18 months after completing Visit 5 as part of an immunogenicity substudy extension. 80 participants enrolled at selected study sites were followed for an additional 6 months after completing Visit 5 as part of a PBMC substudy extension. These substudies investigated exploratory objectives.
Participants by arm
| Arm | Count |
|---|---|
| V116 Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1. | 741 |
| PPSV23 Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1. | 743 |
| Total | 1,484 |
Baseline characteristics
| Characteristic | PPSV23 | Total | V116 |
|---|---|---|---|
| Age, Continuous | 63.7 Years STANDARD_DEVIATION 8.3 | 63.8 Years STANDARD_DEVIATION 8.3 | 63.9 Years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 162 Participants | 313 Participants | 151 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 571 Participants | 1150 Participants | 579 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 21 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 140 Participants | 291 Participants | 151 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 124 Participants | 243 Participants | 119 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 12 Participants | 9 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 469 Participants | 924 Participants | 455 Participants |
| Sex: Female, Male Female | 333 Participants | 665 Participants | 332 Participants |
| Sex: Female, Male Male | 410 Participants | 819 Participants | 409 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 741 | 0 / 743 | 0 / 349 | 0 / 348 | 0 / 41 | 0 / 39 |
| other Total, other adverse events | 399 / 739 | 364 / 741 | 0 / 349 | 0 / 348 | 0 / 41 | 0 / 39 |
| serious Total, serious adverse events | 22 / 739 | 18 / 741 | 0 / 349 | 0 / 348 | 0 / 41 | 0 / 39 |
Outcome results
Primary
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116
The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the unique pneumococcal serotypes contained in V116 was determined. The 9 unique pneumococcal serotypes in V116 are as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Population: Per protocol, all randomized participants who were vaccinated and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 15A | 69.7 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 24F | 50.5 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 31 | 74.4 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 16F | 63.2 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 35B | 63.8 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 15C | 87.9 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 23A | 70.6 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 23B | 86.6 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 6A | 79.1 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 24F | 14.6 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 6A | 53.0 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 15A | 30.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 15C | 76.2 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 16F | 20.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 23B | 44.1 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 31 | 18.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 35B | 5.2 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 | 23A | 34.7 Percentage of Participants |
Comparison: Serotype 6A: V116-PPSV23 Percentage Differencep-value: <0.00195% CI: [20.9, 31]Stratified Miettinen & Nurminen method
Comparison: Serotype 15A: V116-PPSV23 Percentage Differencep-value: <0.00195% CI: [33.6, 44.8]Stratified Miettinen & Nurminen method
Comparison: Serotype 15C: V116-PPSV23 Percentage Differencep-value: 0.21495% CI: [7.5, 15.9]Stratified Miettinen & Nurminen method
Comparison: Serotype 16F: V116-PPSV23 Percentage Differencep-value: <0.00195% CI: [37.8, 47.8]Stratified Miettinen & Nurminen method
Comparison: Serotype 23A: V116-PPSV23 Percentage Differencep-value: <0.00195% CI: [29.6, 41.8]Stratified Miettinen & Nurminen method
Comparison: Serotype 23B: V116-PPSV23 Percentage Differencep-value: <0.00195% CI: [37.6, 47]Stratified Miettinen & Nurminen method
Comparison: Serotype 24F: V116-PPSV23 Percentage Differencep-value: <0.00195% CI: [30.6, 41]Stratified Miettinen & Nurminen method
Comparison: Serotype 31: V116-PPSV23 Percentage Differencep-value: <0.00195% CI: [51.5, 60.5]Stratified Miettinen & Nurminen method
Comparison: Serotype 35B: V116-PPSV23 Percentage Differencep-value: <0.00195% CI: [54.6, 62.7]Stratified Miettinen & Nurminen method
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. Solicited injection-site AEs consisted of pain/tenderness, redness/erythema, and swelling. 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen & Nurminen method.
Time frame: Up to 5 days postvaccination
Population: All randomized participants that received a vaccination. Participants are included in the group corresponding to the vaccination received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) | Injection site pain | 39.0 Percentage of Participants |
| V116 | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) | Injection site erythema | 4.7 Percentage of Participants |
| V116 | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) | Injection site swelling | 4.9 Percentage of Participants |
| PPSV23 | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) | Injection site erythema | 6.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) | Injection site pain | 35.2 Percentage of Participants |
| PPSV23 | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) | Injection site swelling | 4.3 Percentage of Participants |
Comparison: Injection site erythema: estimated difference in percent95% CI: [-4, 0.7]
Comparison: Injection site pain: estimated difference in percent95% CI: [-1.2, 8.7]
Comparison: Injection site swelling: estimated difference in percent95% CI: [-1.6, 2.7]
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. Solicited systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature ≥ 100.4 °F/38.0 °C). 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen & Nurminen method.
Time frame: Up to 5 days postvaccination
Population: All randomized participants that received a vaccination. Participants are included in the group corresponding to the vaccination received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 | Percentage of Participants With Solicited Systemic AEs | Fatigue | 16.5 Percentage of Participants |
| V116 | Percentage of Participants With Solicited Systemic AEs | Headache | 13.7 Percentage of Participants |
| V116 | Percentage of Participants With Solicited Systemic AEs | Myalgia | 5.3 Percentage of Participants |
| V116 | Percentage of Participants With Solicited Systemic AEs | Pyrexia | 1.1 Percentage of Participants |
| PPSV23 | Percentage of Participants With Solicited Systemic AEs | Pyrexia | 1.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With Solicited Systemic AEs | Fatigue | 15.7 Percentage of Participants |
| PPSV23 | Percentage of Participants With Solicited Systemic AEs | Myalgia | 5.9 Percentage of Participants |
| PPSV23 | Percentage of Participants With Solicited Systemic AEs | Headache | 12.0 Percentage of Participants |
Comparison: Fatigue: estimated difference in percent95% CI: [-2.9, 4.6]
Comparison: Headache: estimated difference in percent95% CI: [-1.8, 5.1]
Comparison: Myalgia: estimated difference in percent95% CI: [-3.1, 1.7]
Comparison: Pyrexia: estimated difference in percent95% CI: [-1.5, 0.9]
Primary
Percentage of Participants With Vaccine-Related Serious Adverse Events (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 an other important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination are summarized. 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen & Nurminen method.
Time frame: Up to 6 months postvaccination
Population: All randomized participants that received a vaccination. Participants are included in the group corresponding to the vaccination received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V116 | Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) | 0 Percentage of Participants |
| PPSV23 | Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) | 0 Percentage of Participants |
Comparison: Vaccine-Related Serious Adverse Events95% CI: [-0.5, 0.5]
Primary
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116
Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs), and they hypothesis test (1-sided p-value), were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.
Time frame: Day 30 postvaccination
Population: Per protocol, all randomized participants who were vaccinated and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 8 | 3379.6 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 9N | 7346.6 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 24F | 4568.0 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 10A | 4382.9 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 15C | 7604.8 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 11A | 3711.1 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 31 | 5040.7 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 12F | 3031.8 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 23A | 4804.2 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 17F | 8215.7 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 35B | 10707.5 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 19A | 2670.0 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 15A | 6746.5 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 20A | 6966.1 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 3 | 230.4 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 22F | 4724.1 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 23B | 2252.6 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 33F | 15497.3 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 7F | 4876.7 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 6A | 3193.9 Titers |
| V116 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 16F | 6675.4 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 6A | 964.0 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 15A | 1462.1 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 15C | 2605.0 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 16F | 1482.2 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 23A | 837.2 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 23B | 137.2 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 24F | 1346.7 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 31 | 423.9 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 35B | 1735.0 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 3 | 211.5 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 7F | 3314.6 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 9N | 6545.9 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 10A | 2818.7 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 11A | 1809.7 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 12F | 1854.9 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 17F | 4060.5 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 19A | 1879.9 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 20A | 4208.4 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 22F | 3084.9 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 33F | 17483.0 Titers |
| PPSV23 | Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 | 8 | 2882.1 Titers |
Comparison: Serotype 3: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [0.96, 1.23]cLDA model
Comparison: Serotype 7F: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [1.29, 1.68]cLDA model
Comparison: Serotype 8: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [1.04, 1.32]cLDA model
Comparison: Serotype 9N: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [1, 1.26]cLDA model
Comparison: Serotype 10A: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [1.37, 1.77]cLDA model
Comparison: Serotype 11A: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [1.82, 2.31]cLDA model
Comparison: Serotype 12F: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [1.4, 1.9]cLDA model
Comparison: Serotype 17F: V116/PPSV23GMT Ratiop-value: <0.00195% CI: [1.77, 2.31]cLDA model
Comparison: Serotype 19A: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [1.26, 1.6]cLDA model
Comparison: Serotype 20A: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [1.46, 1.88]cLDA model
Comparison: Serotype 22F: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [1.34, 1.75]cLDA model
Comparison: Serotype 33F: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [0.76, 1.04]cLDA model
Comparison: Serotype 6A: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [2.84, 3.87]cLDA model
Comparison: Serotype 15A: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [3.99, 5.33]cLDA model
Comparison: Serotype 15C: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [2.5, 3.42]cLDA model
Comparison: Serotype 16F: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [3.99, 5.09]cLDA model
Comparison: Serotype 23A: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [4.81, 6.85]cLDA model
Comparison: Serotype 23B: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [13.46, 20.03]cLDA model
Comparison: Serotype 24F: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [2.97, 3.87]cLDA model
Comparison: Serotype 31: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [10.16, 13.91]cLDA model
Comparison: Serotype 35B: V116/PPSV23 GMT Ratiop-value: <0.00195% CI: [5.54, 6.87]cLDA model
Secondary
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific Cross-Reactive OPAs
OPA induced by serotypes 6A and 15C in V116 but cross-reactive to serotypes 6C and 15B, respectively, were measured. The percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs was determined. Point estimate, 95% CI, and p-value are based on the Clopper-Pearson method. Per protocol, this outcome measure was not planned or analyzed in the PPSV23 study arm.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Population: Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination. Per protocol, this outcome measure was not planned or analyzed in the PPSV23 study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific Cross-Reactive OPAs | 15B | 72.6 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific Cross-Reactive OPAs | 6C | 52.7 Percentage of Participants |
Comparison: Serotype 6Cp-value: 0.093Clopper-Pearson method
Comparison: Serotype 15Bp-value: <0.001Clopper-Pearson method
Secondary
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116
The percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs for all serotypes in V116 was determined using PnECL. The within-group CIs were calculated based on the Clopper-Pearson method.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Population: Per protocol, all randomized participants who were vaccinated and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 6A | 81.4 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 8 | 84.4 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 15A | 91.3 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 17F | 91.0 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 15C | 90.7 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 10A | 88.9 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 16F | 83.8 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 23B | 78.9 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 19A | 63.9 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 24F | 88.2 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 7F | 84.8 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 35B | 85.1 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 11A | 76.8 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 33F | 83.0 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 20A | 85.5 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 9N | 85.5 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 23A | 85.9 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 22F | 85.4 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 12F | 86.5 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 31 | 82.0 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 3 | 59.8 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 35B | 2.1 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 3 | 54.7 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 7F | 79.7 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 8 | 86.5 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 9N | 83.2 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 10A | 81.1 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 11A | 56.6 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 12F | 73.7 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 17F | 79.6 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 19A | 58.5 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 20A | 73.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 22F | 77.5 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 6A | 47.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 15A | 34.2 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 15C | 72.1 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 23B | 33.1 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 31 | 11.6 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 33F | 83.5 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 16F | 11.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 23A | 29.9 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 | 24F | 1.7 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116
The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs for all serotypes in V116 was determined with MOPA. The within-group CIs were calculated based on the Clopper-Pearson method.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Population: Per protocol, all randomized participants who were vaccinated and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 23A | 70.6 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 7F | 75.2 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 8 | 83.6 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 9N | 72.3 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 10A | 74.7 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 11A | 72.1 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 12F | 93.3 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 17F | 84.1 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 19A | 70.9 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 20A | 71.0 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 22F | 76.5 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 33F | 66.2 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 6A | 79.1 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 15A | 69.7 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 15C | 87.9 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 16F | 63.2 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 3 | 69.2 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 23B | 86.6 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 24F | 50.5 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 31 | 74.4 Percentage of Participants |
| V116 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 35B | 63.8 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 22F | 67.2 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 3 | 66.9 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 23A | 34.7 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 7F | 69.9 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 33F | 70.9 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 8 | 85.4 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 16F | 20.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 9N | 73.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 6A | 53.0 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 10A | 66.5 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 23B | 44.1 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 11A | 58.8 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 15A | 30.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 12F | 90.7 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 31 | 18.3 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 17F | 71.8 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 15C | 76.2 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 19A | 64.1 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 24F | 14.6 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 20A | 58.1 Percentage of Participants |
| PPSV23 | Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 | 35B | 5.2 Percentage of Participants |
Secondary
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116
The GMFR from baseline in serotype-specific OPA GMTs for all serotypes in V116 was determined using MOPA. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Population: Per protocol, all randomized participants who were vaccinated and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 3 | 7.5 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 10A | 16.6 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 11A | 18.5 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 12F | 89.2 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 17F | 25.2 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 19A | 10.2 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 20A | 10.9 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 22F | 20.5 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 33F | 8.8 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 6A | 19.5 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 15A | 10.4 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 15C | 49.4 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 16F | 7.0 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 23A | 13.9 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 23B | 53.9 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 24F | 5.5 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 31 | 19.5 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 35B | 7.0 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 7F | 18.3 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 8 | 34.3 Ratio |
| V116 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 9N | 11.3 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 35B | 1.1 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 3 | 6.8 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 9N | 11.4 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 15A | 2.4 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 10A | 10.9 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 24F | 1.6 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 11A | 9.2 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 15C | 17.3 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 12F | 58.1 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 8 | 28.8 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 17F | 12.9 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 16F | 1.8 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 19A | 7.2 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 31 | 1.7 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 20A | 6.6 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 23A | 2.7 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 22F | 12.3 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 7F | 14.0 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 33F | 10.2 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 23B | 4.5 Ratio |
| PPSV23 | Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 | 6A | 5.5 Ratio |
Secondary
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116
The GMFR from baseline in GMCs for serotype-specific IgG antibodies for all serotypes in V116 was determined using PnECL. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Population: Per protocol, all randomized participants who were vaccinated and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 3 | 5.3 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 7F | 19.3 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 8 | 16.4 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 9N | 20.1 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 10A | 22.3 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 11A | 10.9 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 12F | 20.5 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 17F | 25.5 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 19A | 7.8 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 20A | 15.8 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 22F | 19.1 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 33F | 14.4 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 6A | 17.1 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 15A | 27.5 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 15C | 30.1 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 16F | 15.4 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 23A | 20.4 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 23B | 13.3 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 24F | 23.0 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 31 | 13.0 Ratio |
| V116 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 35B | 16.8 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 22F | 11.0 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 3 | 4.7 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 24F | 1.1 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 7F | 10.9 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 33F | 12.0 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 8 | 14.1 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 23A | 2.8 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 9N | 13.3 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 6A | 4.6 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 10A | 11.1 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 35B | 1.1 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 11A | 5.0 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 15A | 3.1 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 12F | 10.6 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 23B | 2.9 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 17F | 10.8 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 15C | 8.8 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 19A | 5.3 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 31 | 1.6 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 20A | 8.6 Ratio |
| PPSV23 | Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 | 16F | 1.6 Ratio |
Secondary
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116
The GMCs for serotype-specific IgG antibodies for all serotypes in V116 were determined using pneumococcal electrochemiluminescence (PnECL). The GMC ratio estimation and 95% CI were calculated using a cLDA method. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.
Time frame: Day 30 postvaccination
Population: Per protocol, all randomized participants who were vaccinated and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 15A | 17.98 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 7F | 9.35 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 8 | 13.83 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 9N | 11.21 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 10A | 15.05 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 11A | 8.83 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 12F | 2.28 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 17F | 16.39 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 19A | 9.54 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 22F | 5.32 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 33F | 19.12 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 6A | 5.79 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 15C | 19.27 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 16F | 3.48 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 23A | 4.21 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 23B | 5.74 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 24F | 8.52 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 31 | 3.48 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 35B | 22.26 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 20A | 22.97 μg/mL |
| V116 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 3 | 0.79 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 23A | 0.56 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 3 | 0.69 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 33F | 15.70 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 7F | 5.02 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 35B | 1.43 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 8 | 11.85 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 6A | 1.53 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 9N | 7.23 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 15A | 2.01 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 10A | 7.41 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 23B | 1.20 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 11A | 4.01 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 15C | 5.61 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 12F | 1.14 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 31 | 0.40 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 17F | 6.85 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 16F | 0.35 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 19A | 6.42 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 20A | 12.32 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 24F | 0.40 μg/mL |
| PPSV23 | Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 | 22F | 3.00 μg/mL |
Comparison: Serotype 31: V116/PPSV23 GMC Ratio95% CI: [7.82, 9.65]
Comparison: Serotype 3: V116/PPSV23 GMC Ratio95% CI: [1.04, 1.25]
Comparison: Serotype 7F: V116/PPSV23 GMC Ratio95% CI: [1.65, 2.1]
Comparison: Serotype 35B: V116/PPSV23 GMC Ratio95% CI: [14.13, 17.07]
Comparison: Serotype 8: V116/PPSV23 GMC Ratio95% CI: [1.04, 1.31]
Comparison: Serotype 9N: V116/PPSV23 GMC Ratio95% CI: [1.37, 1.76]
Comparison: Serotype 10A: V116/PPSV23 GMC Ratio95% CI: [1.79, 2.31]
Comparison: Serotype 11A: V116/PPSV23 GMC Ratio95% CI: [1.97, 2.46]
Comparison: Serotype 12F: V116/PPSV23 GMC Ratio95% CI: [1.72, 2.3]
Comparison: Serotype 17F: V116/PPSV23 GMC Ratio95% CI: [2.12, 2.7]
Comparison: Serotype 19A: V116/PPSV23 GMC Ratio95% CI: [1.32, 1.67]
Comparison: Serotype 20A: V116/PPSV23 GMC Ratio95% CI: [1.65, 2.1]
Comparison: Serotype 22F: V116/PPSV23 GMC Ratio95% CI: [1.55, 2.02]
Comparison: Serotype 33F: V116/PPSV23 GMC Ratio95% CI: [1.08, 1.37]
Comparison: Serotype 6A: V116/PPSV23 GMC Ratio95% CI: [3.29, 4.35]
Comparison: Serotype 15A: V116/PPSV23 GMC Ratio95% CI: [7.89, 10.09]
Comparison: Serotype 15C: V116/PPSV23 GMC Ratio95% CI: [3.01, 3.92]
Comparison: Serotype 16F: V116/PPSV23 GMC Ratio95% CI: [8.83, 10.97]
Comparison: Serotype 23A: V116/PPSV23 GMC Ratio95% CI: [6.68, 8.61]
Comparison: Serotype 23B: V116/PPSV23 GMC Ratio95% CI: [4.26, 5.38]
Comparison: Serotype 24F: V116/PPSV23 GMC Ratio95% CI: [18.98, 23.65]