Pneumococcal Infection
Conditions
Brief summary
The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination within each vaccination group separately.
Interventions
BIOLOGICALV116
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
BIOLOGICALPlacebo
Saline in each 0.5 mL sterile solution
BIOLOGICALPCV15
Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 μg of PnPs antigen 6B in each 0.5 mL sterile suspension
BIOLOGICALPPSV23
Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
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 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Has documented result(s) of ≥1 of the following risk conditions for pneumococcal disease: diabetes mellitus, receiving treatment with ≥1 approved antidiabetic medication, with all Hemoglobin A1c (HbA1c) measurements ≤9% within 6 months before first study vaccination; compensated chronic liver disease; diagnosis of chronic obstructive pulmonary disease (COPD) managed per local guidelines; diagnosis of mild or moderate persistent asthma managed per local guidelines; confirmed diagnosis of chronic heart disease managed per local guidelines; confirmed diagnosis of chronic kidney disease (\>3 months duration). * Is receiving stable medical management for the listed risk conditions for ≥3 months with no anticipated major change in treatment expected for the duration of the study and with ≤1 hospitalization directly related to the risk condition. * Female Is not a participant of childbearing potential (POCBP); or if a POCBP Uses an acceptable contraceptive method or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis); their medical history, menstrual history, and recent sexual activity has been reviewed by the investigator.
Exclusion criteria
* Has a history of active hepatitis. * Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before first study vaccination (Day 1). * Has a history of myocardial infarction, acute coronary syndrome, transient ischemic attack, or ischemic or hemorrhagic stroke within 3 months before first study vaccination (Day 1). * Has a history of severe pulmonary hypertension with World Health Organization (WHO) functional class ≥3 or history of Eisenmenger syndrome * Has a history of autoimmune related chronic kidney disease, chronic kidney failure, a reversible cause of kidney disease, nephrotic syndrome, or any ineligible Kidney Disease: Improving Global Outcomes (KDIGO)-recommended stage of glomerular filtration rate (GFR) and Albuminuria * 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 before first study vaccination (Day 1). * Has a known hypersensitivity to any component of V116, PCV15, or PPSV23, including diphtheria toxoid. * Has a known or suspected impairment of immunological function including, but not limited to, congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or autoimmune disease. * Has a coagulation disorder contraindicating intramuscular (IM) vaccination. * Had a recent febrile illness or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of any study vaccine. * Has a known malignancy that is progressing or has required active treatment \<3 years before randomization. * Has planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgical procedure during the duration of this study. * Has expected survival for \<1 year. * Has received any prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol. * Has 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 at Visit 2 (Day 1). * Is currently receiving systemic 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. * Has received any non-live vaccine ≤14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine. * Has received any live virus vaccine (including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) live virus vaccines) ≤30 days before receipt of any study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of any study vaccine * Has received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of any study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of any study vaccine. * Is receiving chronic home oxygen therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Solicited Injection-site Adverse Events (AEs) From Day 1 Through Day 5 Post-vaccination | Up to 5 days following each 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. The percentage of participants with solicited injection-site AEs was assessed following any vaccination. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling. |
| Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination | Up to 5 days following each 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. The percentage of participants with solicited systemic AEs was assessed following any vaccination. Solicited systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature \>= 100.4 °F/38.0 °C). |
| Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through The Duration of Participation in The Study | Up to 194 days following Visit 2 (Day 1) | 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 another important medical event, which is determined by the investigator to be related to the vaccine. The percentage of participants with SAEs was assessed following any vaccination. |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | 30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group. | The serotype specific OPA GMTs for the pneumococcal serotypes were determined using the multiplex opsonophagocytic assay (MOPA). The point estimate was calculated by exponentiating the estimates of the mean of the natural log values and within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | 30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group. | The serotype specific IgG GMCs for the pneumococcal serotypes were determined using pneumococcal electrochemiluminescence assay (PnECL). The point estimate was calculated by exponentiating the estimates of the mean of the natural log values and within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. |
| Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group) | The geometric mean fold rise (GMFR) from baseline to post-vaccination in serotype specific OPA GMTs was determined using MOPA. The within-group 95% confidence intervals (Cis) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. |
| Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group) | The GMFR from baseline to post-vaccination in serotype specific IgG GMCs was determined using Pn electrochemiluminescence (ECL) assay. The within-group 95% confidence intervals (Cis) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. |
| Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group) | The percentage of participants with ≥4-fold rise from baseline to post-vaccination with V116 and PCV15+PPSV23 in serotype-specific OPA responses for pneumococcal serotypes contained in V116 was calculated using MOPA. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. |
| Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group) | The percentage of participants with ≥4-fold rise from baseline to post-vaccination with V116 and PCV15+PPSV23 in serotype-specific OPA responses for pneumococcal serotypes contained in V116 was calculated using Pn ECL assay. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. |
Countries
Australia, Canada, Chile, Japan, New Zealand, Poland, South Korea, United States
Contacts
STUDY_DIRECTORClinical Director
Merck Sharp & Dohme LLC
Participant flow
Recruitment details
Pneumococcal vaccine-naïve adults 18 to 64 years of age (inclusive) with increased risk of pneumococcal disease were enrolled in this study. Participants must have had documented results of ≥ 1 of the following risk conditions: diabetes mellitus, chronic heart disease, chronic kidney disease, chronic liver disease, and/or chronic lung disease. Participants with comorbidities were eligible if the conditions were assessed to be stable as per the investigator's judgment.
Participants by arm
| Arm | Count |
|---|---|
| V116 + Placebo Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8). | 387 |
| PCV15 + PPSV23 Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8). | 131 |
| Total | 518 |
Baseline characteristics
| Characteristic | PCV15 + PPSV23 | Total | V116 + Placebo |
|---|---|---|---|
| Age, Continuous | 53.3 Years STANDARD_DEVIATION 8.9 | 52.6 Years STANDARD_DEVIATION 9.4 | 52.4 Years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants | 136 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 94 Participants | 375 Participants | 281 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 76 Participants | 58 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 18 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 8 Participants | 18 Participants | 10 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 101 Participants | 395 Participants | 294 Participants |
| Sex: Female, Male Female | 55 Participants | 233 Participants | 178 Participants |
| Sex: Female, Male Male | 76 Participants | 285 Participants | 209 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 387 | 0 / 131 |
| other Total, other adverse events | 240 / 386 | 112 / 130 |
| serious Total, serious adverse events | 10 / 386 | 7 / 130 |
Outcome results
Primary
Participants With Solicited Systemic AEs From Day 1 Through Day 5 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. The percentage of participants with solicited systemic AEs was assessed following any vaccination. 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 following each vaccination
Population: All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 + Placebo | Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination | Fatigue | 30.3 Percentage of participants |
| V116 + Placebo | Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination | Headache | 22.3 Percentage of participants |
| V116 + Placebo | Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination | Myalgia | 10.9 Percentage of participants |
| V116 + Placebo | Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination | Pyrexia | 3.1 Percentage of participants |
| PCV15 + PPSV23 | Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination | Pyrexia | 4.6 Percentage of participants |
| PCV15 + PPSV23 | Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination | Fatigue | 45.4 Percentage of participants |
| PCV15 + PPSV23 | Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination | Myalgia | 15.4 Percentage of participants |
| PCV15 + PPSV23 | Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination | Headache | 26.2 Percentage of participants |
Primary
Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through The Duration of Participation in The Study
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 another important medical event, which is determined by the investigator to be related to the vaccine. The percentage of participants with SAEs was assessed following any vaccination.
Time frame: Up to 194 days following Visit 2 (Day 1)
Population: All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V116 + Placebo | Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through The Duration of Participation in The Study | 0.0 Percentage of participants |
| PCV15 + PPSV23 | Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through The Duration of Participation in The Study | 0.0 Percentage of participants |
Primary
Percentage of Participants With Solicited Injection-site Adverse Events (AEs) From Day 1 Through Day 5 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. The percentage of participants with solicited injection-site AEs was assessed following any vaccination. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling.
Time frame: Up to 5 days following each vaccination
Population: All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 + Placebo | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) From Day 1 Through Day 5 Post-vaccination | Injection site erythema | 9.1 Percentage of participants |
| V116 + Placebo | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) From Day 1 Through Day 5 Post-vaccination | Injection site pain | 51.8 Percentage of participants |
| V116 + Placebo | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) From Day 1 Through Day 5 Post-vaccination | Injection site swelling | 8.0 Percentage of participants |
| PCV15 + PPSV23 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) From Day 1 Through Day 5 Post-vaccination | Injection site erythema | 25.4 Percentage of participants |
| PCV15 + PPSV23 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) From Day 1 Through Day 5 Post-vaccination | Injection site pain | 78.5 Percentage of participants |
| PCV15 + PPSV23 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) From Day 1 Through Day 5 Post-vaccination | Injection site swelling | 35.4 Percentage of participants |
Primary
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
The serotype specific OPA GMTs for the pneumococcal serotypes were determined using the multiplex opsonophagocytic assay (MOPA). The point estimate was calculated by exponentiating the estimates of the mean of the natural log values and within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.
Time frame: 30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group.
Population: The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 3 | 216.2 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 6A | 3734.9 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 7F | 4261.2 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 8 | 3460.8 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 9N | 7553.9 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 10A | 4502.0 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 11A | 3761.7 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 12F | 2432.3 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 17F | 10425.3 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 19A | 2837.2 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 20A | 8091.5 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 22F | 4432.7 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 33F | 24512.8 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 15A | 7274.6 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 15C | 7923.1 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 16F | 9546.6 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 23A | 5875.3 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 23B | 2316.9 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 24F | 5677.1 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 31 | 5803.9 Titers |
| V116 + Placebo | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 35B | 13141.3 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 20A | 3749.8 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 3 | 192.9 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 24F | 1666.8 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 6A | 2443.8 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 22F | 2717.4 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 7F | 3218.5 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 23A | 1493.9 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 8 | 3406.4 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 33F | 11395.1 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 9N | 4548.4 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 35B | 1812.1 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 10A | 2542.0 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 15A | 1791.8 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 11A | 1697.2 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 23B | 117.0 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 12F | 1364.5 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 15C | 2269.8 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 17F | 4331.7 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 31 | 360.7 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 19A | 2437.2 Titers |
| PCV15 + PPSV23 | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | Serotype 16F | 1626.2 Titers |
Secondary
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
The percentage of participants with ≥4-fold rise from baseline to post-vaccination with V116 and PCV15+PPSV23 in serotype-specific OPA responses for pneumococcal serotypes contained in V116 was calculated using Pn ECL assay. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.
Time frame: Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)
Population: The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include, but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 3 | 57.8 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 6A | 81.1 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 7F | 88.8 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 8 | 82.2 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 9N | 86.9 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 10A | 86.3 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 11A | 79.8 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 12F | 82.8 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 17F | 93.2 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 19A | 64.2 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 20A | 83.1 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 22F | 85.0 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 33F | 87.2 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 15A | 88.3 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 15C | 88.5 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 16F | 85.8 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 23A | 88.3 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 23B | 81.7 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 24F | 82.0 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 31 | 83.1 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 35B | 79.5 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 20A | 75.7 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 3 | 54.1 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 24F | 2.7 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 6A | 86.5 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 22F | 83.8 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 7F | 83.8 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 23A | 37.8 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 8 | 83.8 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 33F | 79.3 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 9N | 78.4 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 35B | 0.9 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 10A | 79.3 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 15A | 44.1 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 11A | 63.1 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 23B | 43.2 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 12F | 69.4 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 15C | 75.5 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 17F | 82.9 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 31 | 9.9 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 19A | 73.0 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | Serotype 16F | 7.3 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
The percentage of participants with ≥4-fold rise from baseline to post-vaccination with V116 and PCV15+PPSV23 in serotype-specific OPA responses for pneumococcal serotypes contained in V116 was calculated using MOPA. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.
Time frame: Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)
Population: The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 3 | 70.1 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 6A | 79.1 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 7F | 78.3 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 8 | 84.6 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 9N | 74.7 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 10A | 74.9 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 11A | 76.7 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 12F | 94.2 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 17F | 89.6 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 19A | 68.0 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 20A | 66.9 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 22F | 74.8 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 33F | 78.5 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 15A | 67.6 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 15C | 86.0 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 16F | 65.6 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 23A | 71.3 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 23B | 87.7 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 24F | 41.6 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 31 | 77.0 Percentage of Participants |
| V116 + Placebo | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 35B | 64.4 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 20A | 42.3 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 3 | 63.7 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 24F | 6.2 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 6A | 79.3 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 22F | 57.8 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 7F | 63.6 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 23A | 52.6 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 8 | 82.5 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 33F | 58.0 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 9N | 58.9 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 35B | 5.9 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 10A | 70.4 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 15A | 29.5 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 11A | 49.0 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 23B | 49.1 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 12F | 85.0 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 15C | 72.4 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 17F | 76.2 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 31 | 16.2 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 19A | 68.6 Percentage of Participants |
| PCV15 + PPSV23 | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | Serotype 16F | 16.7 Percentage of Participants |
Secondary
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
The geometric mean fold rise (GMFR) from baseline to post-vaccination in serotype specific OPA GMTs was determined using MOPA. The within-group 95% confidence intervals (Cis) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.
Time frame: Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)
Population: The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 3 | 8.3 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 6A | 22.8 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 7F | 20.4 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 8 | 25.7 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 9N | 12.6 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 10A | 19.9 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 11A | 20.7 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 12F | 95.0 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 17F | 28.4 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 19A | 9.7 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 20A | 8.5 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 22F | 15.1 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 33F | 12.3 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 15A | 10.4 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 15C | 52.8 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 16F | 8.6 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 23A | 14.5 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 23B | 83.6 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 24F | 4.0 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 31 | 23.2 Ratio |
| V116 + Placebo | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 35B | 7.2 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 20A | 3.8 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 3 | 6.1 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 24F | 0.9 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 6A | 17.1 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 22F | 9.1 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 7F | 10.5 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 23A | 4.3 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 8 | 25.2 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 33F | 5.5 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 9N | 7.2 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 35B | 1.2 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 10A | 10.7 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 15A | 2.4 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 11A | 6.8 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 23B | 6.2 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 12F | 48.6 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 15C | 18.3 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 17F | 13.1 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 31 | 1.5 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 19A | 9.9 Ratio |
| PCV15 + PPSV23 | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 16F | 1.6 Ratio |
Secondary
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
The GMFR from baseline to post-vaccination in serotype specific IgG GMCs was determined using Pn electrochemiluminescence (ECL) assay. The within-group 95% confidence intervals (Cis) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.
Time frame: Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)
Population: The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 3 | 5.2 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 6A | 16.2 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 7F | 19.0 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 8 | 14.8 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 9N | 19.2 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 10A | 20.1 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 11A | 11.7 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 12F | 17.7 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 17F | 29.6 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 19A | 7.1 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 20A | 15.1 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 22F | 19.7 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 33F | 14.7 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 15A | 23.6 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 15C | 24.2 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 16F | 16.0 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 23A | 20.9 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 23B | 16.6 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 24F | 18.0 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 31 | 14.4 Ratio |
| V116 + Placebo | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 35B | 12.8 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 20A | 8.7 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 3 | 4.5 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 24F | 1.1 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 6A | 20.1 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 22F | 13.2 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 7F | 12.8 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 23A | 3.8 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 8 | 15.5 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 33F | 11.0 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 9N | 9.9 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 35B | 1.0 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 10A | 11.0 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 15A | 3.7 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 11A | 5.6 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 23B | 3.7 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 12F | 8.1 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 15C | 9.2 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 17F | 13.9 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 31 | 1.5 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 19A | 8.1 Ratio |
| PCV15 + PPSV23 | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | Serotype 16F | 1.6 Ratio |
Secondary
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
The serotype specific IgG GMCs for the pneumococcal serotypes were determined using pneumococcal electrochemiluminescence assay (PnECL). The point estimate was calculated by exponentiating the estimates of the mean of the natural log values and within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.
Time frame: 30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group.
Population: The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 3 | 0.77 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 6A | 4.57 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 7F | 8.77 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 8 | 10.20 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 9N | 7.53 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 10A | 12.18 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 11A | 7.78 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 12F | 1.90 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 17F | 17.35 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 19A | 9.11 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 20A | 19.51 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 22F | 5.17 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 33F | 15.38 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 15A | 14.65 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 15C | 14.48 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 16F | 2.90 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 23A | 3.85 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 23B | 6.62 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 24F | 5.18 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 31 | 3.27 μg/mL |
| V116 + Placebo | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 35B | 19.78 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 20A | 13.38 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 3 | 0.79 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 24F | 0.34 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 6A | 5.83 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 22F | 3.98 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 7F | 6.95 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 23A | 0.79 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 8 | 12.50 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 33F | 11.40 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 9N | 4.35 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 35B | 1.55 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 10A | 6.88 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 15A | 2.37 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 11A | 4.04 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 23B | 1.46 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 12F | 0.84 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 15C | 5.42 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 17F | 8.20 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 31 | 0.38 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 19A | 10.88 μg/mL |
| PCV15 + PPSV23 | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | Serotype 16F | 0.27 μg/mL |