Pneumococcal Infection
Conditions
Brief summary
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine (\[Prevnar 20™ / APEXXNAR™\]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.
Interventions
BIOLOGICALV116
0.5 mL injection solution in prefilled syringe containing 4 μg of each PnPs antigen (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) given by intramuscular (IM) injection.
BIOLOGICALPCV20
0.5 mL injection suspension in prefilled syringe containing 2.2 μg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 μg of PnPs antigen 6B.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 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 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 PCV20, 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 administration (prior to age of 5 is acceptable) of any 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 post-vaccination | 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 consist of the following: pain/tenderness, redness/erythema, and swelling. |
| Percentage of Participants With Solicited Systemic AEs | Up to 5 days post-vaccination | 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) |
| Percentage of Participants With Vaccine-related Serious AE (SAE) | Up to 194 days post-vaccination | A vaccine-related SAE is any untoward medical consequence 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, which is determined by the investigator to be related to the vaccine. |
| Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Day 30 post-vaccination | The serotype specific OPA GMTs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using the multiplex opsonophagocytic assay (MOPA). GMT values were estimated from a constrained longitudinal data analysis; (cLDA) model. Per protocol, within group, confidence intervals (CIs) or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure. |
| Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Baseline and Day 30 post-vaccination | The percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs for the 11 unique pneumococcal serotypes contained in V116. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure. |
| Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Day 30 post-vaccination | The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA. GMT values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants From Cohort 1 V116 With ≥4-fold Change in OPA Responses for Cross Reactive Pneumococcal Serotypes | Baseline and Day 30 post-vaccination | The percentage of participants with ≥4-fold rise from baseline was determined for Cohort 1 V116 serotypes 6C and 15B, two serotypes which cross react with PCV20. Point estimate and 95% CI are based on the Clopper-Pearson method. A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a ≥4-fold rise from baseline being \> 50 percentage points (one-sided p-value \< 0.025). Per protocol, participants treated with PCV20, and V116 Cohort 2 were not analyzed in this outcome measure. |
| Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Baseline and Day 30 post-vaccination | Percentage of participants with ≥4-fold rise from baseline in OPA GMTs in Cohort 1 was determined using MOPA. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure. |
| Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2 | Day 30 post-vaccination | The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA for serotypes 6C and 15B which cross react with PCV20. GMT values were estimated from a LDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure. |
| Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Day 30 post-vaccination | The serotype specific IgG GMCs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using pneumococcal electrochemiluminescence (PnECL). GMC values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure. |
| Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Baseline and Day 30 post-vaccination | The geometric mean fold rise (GMFR) from baseline in serotype specific OPA GMTs for cohort 1 was determined using MOPA. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure. |
| Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Baseline and Day 30 post-vaccination | The GMFR from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure. |
| Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Baseline and Day 30 post-vaccination | Percentage of participants with ≥4-fold rise from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure. |
Countries
Australia, Belgium, Chile, Germany, New Zealand, Puerto Rico, South Korea, Sweden, Taiwan, Turkey (Türkiye), United States
Participant flow
Recruitment details
Pneumococcal vaccine-naïve adults ≥18 years of age were enrolled in this study. Participants with underlying chronic conditions were eligible if the conditions were assessed to be stable per the investigator's judgment.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 V116 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1. | 1,179 |
| Cohort 1 PCV20 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1. | 1,177 |
| Cohort 2 V116 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1. | 200 |
| Cohort 2 PCV20 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1. | 100 |
| Total | 2,656 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 4 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 10 | 15 | 5 | 3 |
| Overall Study | Physician Decision | 0 | 2 | 0 | 0 |
| Overall Study | Randomized By Mistake Without Study Treatment | 1 | 2 | 0 | 0 |
| Overall Study | Randomized to PCV20 first, discontinued; then randomized to V116 second | 2 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 8 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Cohort 1 PCV20 | Cohort 1 V116 | Cohort 2 V116 | Cohort 2 PCV20 |
|---|---|---|---|---|---|
| Age, Continuous | 60.7 Years STANDARD_DEVIATION 12.4 | 63.9 Years STANDARD_DEVIATION 8.3 | 63.9 Years STANDARD_DEVIATION 8.3 | 35.2 Years STANDARD_DEVIATION 9 | 34.6 Years STANDARD_DEVIATION 8.7 |
| Age, Customized 18 to 49 years | 300 Participants | 0 Participants | 0 Participants | 200 Participants | 100 Participants |
| Age, Customized 50 to 64 years | 1176 Participants | 587 Participants | 589 Participants | 0 Participants | 0 Participants |
| Age, Customized 65 to 74 years | 928 Participants | 464 Participants | 464 Participants | 0 Participants | 0 Participants |
| Age, Customized 75 to 84 years | 225 Participants | 113 Participants | 112 Participants | 0 Participants | 0 Participants |
| Age, Customized ≥85 years | 27 Participants | 13 Participants | 14 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 583 Participants | 242 Participants | 259 Participants | 58 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2048 Participants | 922 Participants | 909 Participants | 141 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 25 Participants | 13 Participants | 11 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants | 4 Participants | 4 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 369 Participants | 168 Participants | 148 Participants | 38 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 258 Participants | 115 Participants | 116 Participants | 13 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 71 Participants | 30 Participants | 26 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 36 Participants | 16 Participants | 17 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1912 Participants | 844 Participants | 867 Participants | 139 Participants | 62 Participants |
| Sex: Female, Male Female | 1558 Participants | 670 Participants | 687 Participants | 137 Participants | 64 Participants |
| Sex: Female, Male Male | 1098 Participants | 507 Participants | 492 Participants | 63 Participants | 36 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 1,179 | 2 / 1,179 | 0 / 201 | 0 / 100 | 0 / 2 |
| other Total, other adverse events | 615 / 1,177 | 722 / 1,175 | 161 / 200 | 78 / 100 | 0 / 2 |
| serious Total, serious adverse events | 19 / 1,177 | 24 / 1,175 | 1 / 200 | 3 / 100 | 0 / 2 |
Outcome results
Primary
Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116
The percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs for the 11 unique pneumococcal serotypes contained in V116. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Time frame: Baseline and Day 30 post-vaccination
Population: All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Cohort 2 were not analyzed in this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 15A | 66.7 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 23A | 78.9 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 35B | 60.0 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 9N | 64.7 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 15C | 83.4 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 16F | 71.9 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 17F | 75.8 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 20A | 67.3 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 23B | 85.5 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 24F | 80.5 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 31 | 76.5 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 31 | 17.9 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 17F | 9.5 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 23A | 36.8 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 24F | 6.3 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 20A | 9.6 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 9N | 19.9 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 15A | 35.8 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 35B | 6.8 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 15C | 74.2 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 23B | 49.6 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 | Serotype 16F | 20.8 Percentage of participants |
Comparison: Serotype 9N: V116-PCV20 Percentage Differencep-value: <0.00195% CI: [40.7, 48.6]Stratified Miettinen & Nurminen
Comparison: Serotype 15A: V116-PCV20 Percentage Differencep-value: <0.00195% CI: [25.8, 35.8]Stratified Miettinen & Nurminen
Comparison: Serotype 15C: V116-PCV20 Percentage Differencep-value: <0.00195% CI: [5.6, 12.9]Stratified Miettinen & Nurminen
Comparison: Serotype 16F: V116-PCV20 Percentage Differencep-value: <0.00195% CI: [47.1, 54.9]Stratified Miettinen & Nurminen
Comparison: Serotype 17F: V116-PCV20 Percentage Differencep-value: <0.00195% CI: [62.8, 69.6]Stratified Miettinen & Nurminen
Comparison: Serotype 20A: V116-PCV20 Percentage Differencep-value: <0.00195% CI: [54.2, 61.1]Stratified Miettinen & Nurminen
Comparison: Serotype 23A: V116-PCV20 Percentage Differencep-value: <0.00195% CI: [37.6, 46.6]Stratified Miettinen & Nurminen
Comparison: Serotype 23B: V116-PCV20 Percentage Differencep-value: <0.00195% CI: [32.1, 39.6]Stratified Miettinen & Nurminen
Comparison: Serotype24F: V116-PCV20 Percentage Differencep-value: <0.00195% CI: [71.1, 77.1]Stratified Miettinen & Nurminen
Comparison: Serotype 31: V116-PCV20 Percentage Differencep-value: <0.00195% CI: [54.8, 62.1]Stratified Miettinen & Nurminen
Comparison: Serotype35B: V116-PCV20 Percentage Differencep-value: <0.00195% CI: [49.6, 56.6]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. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling.
Time frame: Up to 5 days post-vaccination
Population: All participants as treated consisting of randomized participants who were included in the group corresponding to the vaccine actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site erythema | 5.4 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site swelling | 6.0 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site pain | 39.4 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site erythema | 6.3 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site swelling | 8.3 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site pain | 51.7 Percentage of participants |
| Cohort 2 V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site pain | 71.5 Percentage of participants |
| Cohort 2 V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site erythema | 15.5 Percentage of participants |
| Cohort 2 V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site swelling | 14.0 Percentage of participants |
| Cohort 2 PCV20 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site erythema | 13.0 Percentage of participants |
| Cohort 2 PCV20 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site swelling | 14.0 Percentage of participants |
| Cohort 2 PCV20 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site pain | 74.0 Percentage of participants |
Comparison: Injection site erythema: estimated difference in percent96% CI: [-2.8, 1.1]
Comparison: Injection site pain: estimated difference in percent95% CI: [-16.2, -8.2]
Comparison: Injection site swelling: estimated difference in percent95% CI: [-4.4, -0.2]
Comparison: Injection site erythema: estimated difference in percent95% CI: [-6.6, 10.3]
Comparison: Injection site pain: estimated difference in percent95% CI: [-12.7, 8.6]
Comparison: Injection site swelling: estimated difference in percent95% CI: [-9.2, 7.9]
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)
Time frame: Up to 5 days post-vaccination
Population: All participants as treated consisting of randomized participants who were included in the group corresponding to the vaccine actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 V116 | Percentage of Participants With Solicited Systemic AEs | Fatigue | 20.1 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With Solicited Systemic AEs | Headache | 11.5 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With Solicited Systemic AEs | Myalgia | 5.9 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With Solicited Systemic AEs | Pyrexia | 1.3 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With Solicited Systemic AEs | Headache | 12.9 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With Solicited Systemic AEs | Myalgia | 6.7 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With Solicited Systemic AEs | Pyrexia | 1.3 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With Solicited Systemic AEs | Fatigue | 19.6 Percentage of participants |
| Cohort 2 V116 | Percentage of Participants With Solicited Systemic AEs | Myalgia | 16.5 Percentage of participants |
| Cohort 2 V116 | Percentage of Participants With Solicited Systemic AEs | Headache | 29.5 Percentage of participants |
| Cohort 2 V116 | Percentage of Participants With Solicited Systemic AEs | Pyrexia | 3.5 Percentage of participants |
| Cohort 2 V116 | Percentage of Participants With Solicited Systemic AEs | Fatigue | 40.5 Percentage of participants |
| Cohort 2 PCV20 | Percentage of Participants With Solicited Systemic AEs | Pyrexia | 1.0 Percentage of participants |
| Cohort 2 PCV20 | Percentage of Participants With Solicited Systemic AEs | Headache | 24.0 Percentage of participants |
| Cohort 2 PCV20 | Percentage of Participants With Solicited Systemic AEs | Fatigue | 34.0 Percentage of participants |
| Cohort 2 PCV20 | Percentage of Participants With Solicited Systemic AEs | Myalgia | 14.0 Percentage of participants |
Comparison: Fatigue: estimated difference in percent95% CI: [-2.7, 3.8]
Comparison: Headache: estimated difference in percent95% CI: [-4.1, 1.2]
Comparison: Myalgia: estimated difference in percent96% CI: [-2.8, 1.2]
Comparison: Pyrexia: estimated difference in percent95% CI: [-1, 1]
Comparison: Fatigue: estimated difference in percent95% CI: [-5.3, 17.6]
Comparison: Headache: estimated difference in percent5% CI: [-5.5, 15.5]
Comparison: Myalgia: estimated difference in percent95% CI: [-6.8, 10.6]
Comparison: Pyrexia: estimated difference in percent95% CI: [-2.2, 6.2]
Primary
Percentage of Participants With Vaccine-related Serious AE (SAE)
A vaccine-related SAE is any untoward medical consequence 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, which is determined by the investigator to be related to the vaccine.
Time frame: Up to 194 days post-vaccination
Population: All participants as treated consisting of randomized participants who were included in the group corresponding to the vaccine actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 V116 | Percentage of Participants With Vaccine-related Serious AE (SAE) | 0.0 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With Vaccine-related Serious AE (SAE) | 0.0 Percentage of participants |
| Cohort 2 V116 | Percentage of Participants With Vaccine-related Serious AE (SAE) | 0.0 Percentage of participants |
| Cohort 2 PCV20 | Percentage of Participants With Vaccine-related Serious AE (SAE) | 0.0 Percentage of participants |
Primary
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA. GMT values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.
Time frame: Day 30 post-vaccination
Population: All randomized participants treated with V116 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 6A | 5289.6 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 16F | 8877.0 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 23B | 2140.1 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 3 | 308.6 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 7F | 6447.2 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 8 | 4516.0 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 9N | 17283.2 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 10A | 6808.1 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 11A | 5871.6 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 12F | 6150.4 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 15A | 11319.2 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 15C | 10194.0 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype17F | 16070.6 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 19A | 2773.2 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 20A | 13150.0 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 22F | 9299.6 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 23A | 8848.7 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 24F | 4137.6 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 31 | 8005.6 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 33F | 34805.5 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 35B | 13933.4 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 15C | 5708.0 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 16F | 5720.0 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 23B | 1420.9 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype17F | 10068.0 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 3 | 282.7 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 6A | 2572.9 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 35B | 9053.9 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 7F | 4278.8 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 19A | 2374.6 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 8 | 3004.7 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 24F | 3047.2 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 9N | 8791.4 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 20A | 7562.7 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 10A | 4382.6 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 33F | 17607.4 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 11A | 3785.8 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 22F | 4683.6 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 12F | 3561.2 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 31 | 3820.7 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 15A | 5901.2 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 | Serotype 23A | 4739.5 Titer |
Comparison: Serotype 3: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [0.9, 1.33]LDA model
Comparison: Serotype 6A: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.61, 2.62]LDA model
Comparison: Serotype 7F: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.0015% CI: [1.23, 1.84]LDA model
Comparison: Serotype 8: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.26, 1.79]LDA model
Comparison: Serotype 9N: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.59, 2.43]LDA model
Comparison: Serotype 10A: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.26, 1.92]LDA model
Comparison: Serotype 11A: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.26, 1.91]LDA model
Comparison: Serotype 12F: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.37, 2.17]LDA model
Comparison: Serotype 15A: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.55, 2.37]LDA model
Comparison: Serotype 15C: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.36, 2.35]LDA model
Comparison: Serotype 16F: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.26, 1.91]LDA model
Comparison: Serotype 17F: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.26, 2.02]LDA model
Comparison: Serotype 19A: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [0.97, 1.4]LDA model
Comparison: Serotype 20A: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.39, 2.18]LDA model
Comparison: Serotype 22F: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.58, 2.49]LDA model
Comparison: Serotype 23A: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.43, 2.44]LDA model
Comparison: Serotype 23B: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.11, 2.04]LDA model
Comparison: Serotype 24F: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.1, 1.67]LDA model
Comparison: Serotype 31: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.63, 2.69]LDA model
Comparison: Serotype 33F: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.52, 2.57]LDA model
Comparison: Serotype 35B: V116 18-49 years/V116 50-64 years GMT Ratiop-value: <0.00195% CI: [1.26, 1.87]LDA model
Primary
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
The serotype specific OPA GMTs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using the multiplex opsonophagocytic assay (MOPA). GMT values were estimated from a constrained longitudinal data analysis; (cLDA) model. Per protocol, within group, confidence intervals (CIs) or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Time frame: Day 30 post-vaccination
Population: All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 9N | 7470.7 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 11A | 3232.6 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype15A | 5237.2 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 6A | 2302.0 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15C | 4216.2 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 8 | 2501.3 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 16F | 4868.2 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 19A | 2136.1 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 17F | 7764.9 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 3 | 274.0 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 20A | 6099.2 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 22F | 3874.5 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23A | 3737.2 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 10A | 3893.4 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23B | 1082.5 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 33F | 13558.9 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 24F | 2728.6 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 7F | 3637.4 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 31 | 3132.5 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 35B | 8527.8 Titer |
| Cohort 1 V116 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 12F | 2641.2 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 35B | 1383.0 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 31 | 144.4 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 3 | 176.7 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 6A | 2972.5 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 7F | 3429.9 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 8 | 1811.1 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 10A | 4678.0 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 11A | 2092.8 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 12F | 2499.6 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 19A | 2817.8 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 22F | 4770.1 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 33F | 11742.1 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 9N | 1640.4 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype15A | 1589.0 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15C | 2072.3 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 16F | 846.3 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 17F | 460.4 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 20A | 631.1 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23A | 461.5 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23B | 107.3 Titer |
| Cohort 1 PCV20 | Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 24F | 70.5 Titer |
Comparison: Serotype 3: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [1.4, 1.72]cLDA model
Comparison: Serotype 6A: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [0.68, 0.88]cLDA model
Comparison: Serotype 7F: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [0.95, 1.18]cLDA model
Comparison: Serotype 8: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [1.25, 1.53]cLDA model
Comparison: Serotype 10A: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [0.75, 0.93]cLDA model
Comparison: Serotype 11A: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [1.39, 1.72]cLDA model
Comparison: Serotype 12F: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [0.92, 1.21]cLDA model
Comparison: Serotype 19A: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [0.69, 0.84]cLDA model
Comparison: Serotype 22F: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [0.72, 0.92]cLDA model
Comparison: Serotype 33F: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [1.01, 1.32]cLDA model
Comparison: Serotype 9N: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [4.12, 5.04]cLDA model
Comparison: Serotype 15A: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [2.91, 3.74]cLDA model
Comparison: Serotype 15C: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [1.77, 2.34]cLDA model
Comparison: Serotype 16F: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [5.16, 6.41]cLDA model
Comparison: Serotype 17F: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [14.9, 19.09]cLDA model
Comparison: Serotype 20A: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [8.66, 10.79]cLDA model
Comparison: Serotype 23A: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [6.86, 9.55]cLDA model
Comparison: Serotype 23B: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [8.48, 12]cLDA model
Comparison: Serotype 24F: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [33.87, 44.25]cLDA model
Comparison: Serotype 31: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [18.68, 25.18]cLDA model
Comparison: Serotype 35B: V116/PCV20 GMT Ratiop-value: <0.00195% CI: [5.59, 6.8]cLDA model
Secondary
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
The GMFR from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Time frame: Baseline and Day 30 post-vaccination
Population: All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23B | 12.1 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 6A | 12.2 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 7F | 12.5 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 8 | 12.6 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 10A | 15.4 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype11A | 8.7 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 12F | 13.1 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 19A | 5.4 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 22F | 12.7 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 33F | 9.6 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 9N | 15.0 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15A | 22.3 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15C | 19.8 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 16F | 13.3 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 17F | 19.8 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23A | 17.8 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 3 | 5.1 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 20A | 11.7 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 24F | 21.2 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 31 | 13.0 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 35B | 14.7 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 3 | 3.5 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15A | 3.4 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 6A | 15.1 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15C | 8.2 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 7F | 12.2 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 35B | 1.0 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 8 | 8.8 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 16F | 1.6 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 10A | 19.2 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23B | 3.8 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype11A | 7.1 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 17F | 1.2 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 12F | 12.1 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 20A | 0.9 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 19A | 7.7 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 31 | 1.2 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 22F | 16.3 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23A | 2.9 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 33F | 9.1 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 24F | 1.1 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 9N | 2.7 GMFR |
Secondary
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
The geometric mean fold rise (GMFR) from baseline in serotype specific OPA GMTs for cohort 1 was determined using MOPA. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Time frame: Baseline and Day 30 post-vaccination
Population: All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 10A | 16.7 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15A | 9.4 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 7F | 16.5 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15C | 38.0 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 12F | 77.4 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 16F | 9.5 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 6A | 18.1 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 17F | 17.3 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 19A | 8.6 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 20A | 10.3 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 8 | 22.0 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23A | 21.8 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 22F | 19.1 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23B | 51.4 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 3 | 8.4 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 24F | 29.0 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 33F | 9.9 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 31 | 28.7 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 9N | 8.9 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 35B | 7.2 GMFR |
| Cohort 1 V116 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype11A | 17.4 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 35B | 1.2 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype11A | 11.6 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 33F | 8.5 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 3 | 5.4 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 6A | 22.6 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 7F | 14.7 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 8 | 14.2 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 10A | 20.8 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 12F | 73.5 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 19A | 11.0 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 22F | 25.5 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 9N | 2.0 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15A | 3.1 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15C | 20.3 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 16F | 1.9 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 17F | 1.2 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 20A | 1.2 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23A | 3.1 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23B | 6.1 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 24F | 1.1 GMFR |
| Cohort 1 PCV20 | Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 31 | 1.5 GMFR |
Secondary
Percentage of Participants From Cohort 1 V116 With ≥4-fold Change in OPA Responses for Cross Reactive Pneumococcal Serotypes
The percentage of participants with ≥4-fold rise from baseline was determined for Cohort 1 V116 serotypes 6C and 15B, two serotypes which cross react with PCV20. Point estimate and 95% CI are based on the Clopper-Pearson method. A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a ≥4-fold rise from baseline being \> 50 percentage points (one-sided p-value \< 0.025). Per protocol, participants treated with PCV20, and V116 Cohort 2 were not analyzed in this outcome measure.
Time frame: Baseline and Day 30 post-vaccination
Population: All randomized participants treated with V116 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, participants treated with PCV20 and V116 Cohort 2 were not analyzed in this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 V116 | Percentage of Participants From Cohort 1 V116 With ≥4-fold Change in OPA Responses for Cross Reactive Pneumococcal Serotypes | Serotype 6C | 49.3 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants From Cohort 1 V116 With ≥4-fold Change in OPA Responses for Cross Reactive Pneumococcal Serotypes | Serotype 15B | 64.7 Percentage of participants |
Comparison: Serotype 6Cp-value: 0.667Clopper-Pearson method.
Comparison: Serotype 15Bp-value: <0.001Clopper-Pearson method.
Secondary
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Percentage of participants with ≥4-fold rise from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Time frame: Baseline and Day 30 post-vaccination
Population: All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype11A | 71.1 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15A | 85.7 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 6A | 73.1 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15C | 81.4 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 12F | 74.2 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 16F | 81.4 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 3 | 56.5 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 17F | 84.5 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 19A | 55.6 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 20A | 74.7 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 10A | 80.3 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23A | 85.5 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 22F | 76.8 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23B | 76.1 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 7F | 76.4 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 24F | 84.0 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 33F | 71.6 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 31 | 81.1 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 9N | 77.9 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 35B | 83.1 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 8 | 75.8 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 35B | 3.3 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 33F | 66.7 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 3 | 41.0 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 6A | 79.7 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 7F | 75.8 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 8 | 67.8 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 10A | 82.0 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype11A | 62.7 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 12F | 71.4 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 19A | 65.0 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 22F | 78.5 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 9N | 29.4 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15A | 37.7 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15C | 63.2 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 16F | 11.8 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 17F | 4.3 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 20A | 1.3 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23A | 29.4 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23B | 42.2 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 24F | 2.3 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 31 | 3.9 Percentage of participants |
Secondary
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Percentage of participants with ≥4-fold rise from baseline in OPA GMTs in Cohort 1 was determined using MOPA. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Time frame: Baseline and Day 30 post-vaccination
Population: All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 19A | 64.4 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 22F | 70.5 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23B | 85.5 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 33F | 67.7 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 7F | 71.0 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 9N | 64.7 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15C | 83.4 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 8 | 75.8 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 16F | 71.9 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 31 | 76.5 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 17F | 75.8 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 10A | 71.9 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 20A | 67.3 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 3 | 71.3 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23A | 78.9 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype11A | 70.0 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 24F | 80.5 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15A | 66.7 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 12F | 89.0 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 35B | 60.0 Percentage of participants |
| Cohort 1 V116 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 6A | 76.8 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 35B | 6.8 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15C | 74.2 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23B | 49.6 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 3 | 59.1 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 6A | 79.9 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 7F | 65.9 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 8 | 67.4 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 10A | 74.1 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype11A | 61.5 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 12F | 87.1 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 22F | 74.4 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 33F | 61.5 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 9N | 19.9 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15A | 35.8 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 16F | 20.8 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 17F | 9.5 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 20A | 9.6 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23A | 36.8 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 24F | 6.3 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 31 | 17.9 Percentage of participants |
| Cohort 1 PCV20 | Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 19A | 70.2 Percentage of participants |
Secondary
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
The serotype specific IgG GMCs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using pneumococcal electrochemiluminescence (PnECL). GMC values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Time frame: Day 30 post-vaccination
Population: All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 19A | 8.39 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 7F | 6.97 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 22F | 4.39 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 31 | 3.07 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 33F | 13.81 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 8 | 10.02 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 3 | 0.78 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype15A | 13.88 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 10A | 11.98 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15C | 12.39 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 17F | 14.16 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 16F | 2.86 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 11A | 7.20 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 6A | 4.30 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 20A | 19.03 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 9N | 7.72 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23A | 3.78 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 12F | 1.73 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23B | 5.13 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 35B | 19.98 μg/mL |
| Cohort 1 V116 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 24F | 6.87 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 20A | 1.47 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 24F | 0.33 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 31 | 0.27 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 35B | 1.41 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 3 | 0.53 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 6A | 5.45 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 7F | 6.57 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 8 | 7.00 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 10A | 14.66 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 11A | 5.87 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 12F | 1.57 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 19A | 12.02 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 22F | 5.48 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 33F | 13.02 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 9N | 1.43 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype15A | 2.04 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 15C | 5.04 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 16F | 0.33 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 17F | 0.84 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23A | 0.59 μg/mL |
| Cohort 1 PCV20 | Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 | Serotype 23B | 1.58 μg/mL |
Comparison: Serotype 3: V116/PCV20 GMC Ratio95% CI: [1.35, 1.6]
Comparison: Serotype 6A: V116/PCV20 GMC Ratio95% CI: [0.7, 0.89]
Comparison: Serotype 7F: V116/PCV20 GMC Ratio95% CI: [0.95, 1.18]
Comparison: Serotype 8: V116/PCV20 GMC Ratio95% CI: [1.29, 1.59]
Comparison: Serotype 10A: V116/PCV20 GMC Ratio95% CI: [0.72, 0.92]
Comparison: Serotype 11A: V116/PCV20 GMC Ratio95% CI: [1.11, 1.36]
Comparison: Serotype 12F: V116/PCV20 GMC Ratio95% CI: [0.96, 1.26]
Comparison: Serotype 19A: V116/PCV20 GMC Ratio95% CI: [0.63, 0.77]
Comparison: Serotype 22F: V116/PCV20 GMC Ratio95% CI: [0.72, 0.9]
Comparison: Serotype 33F: V116/PCV20 GMC Ratio95% CI: [0.95, 1.18]
Comparison: Serotype 9N: V116/PCV20 GMC Ratio95% CI: [4.82, 6.06]
Comparison: Serotype 15A: V116/PCV20 GMC Ratio95% CI: [6.03, 7.64]
Comparison: Serotype 15C: V116/PCV20 GMC Ratio95% CI: [2.17, 2.79]
Comparison: Serotype 16F: V116/PCV20 GMC Ratio95% CI: [7.95, 9.64]
Comparison: Serotype 17F: V116/PCV20 GMC Ratio95% CI: [15.25, 18.41]
Comparison: Serotype 20A: V116/PCV20 GMC Ratio5% CI: [11.81, 14.13]
Comparison: Serotype 23A: V116/PCV20 GMC Ratio95% CI: [5.69, 7.24]
Comparison: Serotype 23B: V116/PCV20 GMC Ratio95% CI: [2.91, 3.64]
Comparison: Serotype 24F: V116/PCV20 GMC Ratio85% CI: [18.97, 23.43]
Comparison: Serotype 31: V116/PCV20 GMC Ratio95% CI: [10.36, 12.34]
Comparison: Serotype 35B: V116/PCV20 GMC Ratio95% CI: [12.97, 15.4]
Secondary
Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2
The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA for serotypes 6C and 15B which cross react with PCV20. GMT values were estimated from a LDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.
Time frame: Day 30 post-vaccination
Population: All randomized participants treated with V116 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 V116 | Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2 | 6C | 2577.2 Titer |
| Cohort 1 V116 | Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2 | 15B | 10976.7 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2 | 6C | 1254.7 Titer |
| Cohort 1 PCV20 | Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2 | 15B | 5438.9 Titer |
Comparison: Serotype 6C: V116 18-49 years/V116 50-64 years GMT Ratio95% CI: [1.52, 2.77]
Comparison: Serotype 15B: V116 18-49 years/V116 50-64 years GMT ratiop-value: <0.00195% CI: [1.57, 2.6]LDA model