Pneumonia, Pneumococcal
Conditions
Brief summary
This Phase 1 and Phase 2 study will evaluate the safety, tolerability and immunogenicity of V116 when administered to adults. Phase 1 has no formal hypothesis. The primary hypotheses for Phase 2 are: V116 is noninferior to Pneumovax™23 as measured by the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for the common serotypes at 30 days postvaccination and that the serotype-specific OPA GMTs for the unique serotypes in V116 at 30 days postvaccination are statistically significantly greater following vaccination with V116 than those following vaccination with Pneumovax™23.
Interventions
BIOLOGICALV116
Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
BIOLOGICALPneumovax™23
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 No maximum
Healthy volunteers
Yes
Inclusion criteria
* Phase 1: * Male or female, from 18 years to 49 years of age inclusive * Phase 2: * Male or female ≥50 years of age Phase 1 and Phase 2 * Males: refrain from donating sperm, remain abstinent during study or agree to use condom * Females: Not pregnant. If a woman of childbearing potential, agree to use contraception or remain abstinent
Exclusion criteria
* History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years of screening * Known hypersensitivity to any component of the pPCV, or any diphtheria toxoid-containing vaccine * 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 * Coagulation disorder contraindicating IM vaccination * 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 within 72 hours of screening * Known malignancy that is progressing or has required active treatment within 3 years.(Note: participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ \[eg, breast carcinoma, cervical cancer in situ\] that have undergone potentially curative therapy are not excluded) * Pregnant * Received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study, outside of the protocol. * Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease * Received a blood transfusion or blood products, including immunoglobulin, 6 months before study vaccination or is scheduled to receive a blood transfusion or blood product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | 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. Injection-site AEs solicited on the Vaccine Report Card (VRC) were redness/erythema, swelling, and tenderness/pain. The percentage of participants with one or more solicited injection-site AE was assessed. |
| Phase 1: Percentage of Participants With a Solicited Systemic AE | 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. Systemic AEs solicited on the VRC were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was assessed. |
| Phase 1: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | Up to Day 195 | A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination were reported. |
| Phase 2: Percentage of Participants With a Solicited Injection-site AE | 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. Injection-site AEs solicited on the Vaccine Report Card (VRC) were redness/erythema, swelling, and tenderness/pain. The percentage of participants with one or more solicited injection-site AE was assessed. |
| Phase 2: Percentage of Participants With a Solicited Systemic AE | 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. Systemic AEs solicited on the VRC were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with 1 or more solicited systemic AE was assessed. |
| Phase 2: Percentage of Participants With Vaccine-related SAEs | Up to Day 293 | An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced at least one SAE that were assessed by the investigator to be at least possibly related to the study vaccination were reported. |
| Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | 30 days post vaccination | GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the muliplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated. |
| Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | 30 days post vaccination | GMTs for the serotypes unique to V116 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group CIs were not calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Baseline (Day 1) and 30 days post vaccination | GMTs for the serotypes in V116 and Pneumovax™23 were determined using the MOPA at baseline and at 30 days post vaccination and derived from a cLDA model. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMT/Day 1 GMT. |
| Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | 30 days post vaccination | Serotype-specific pneumococcal IgG antibodies were measured using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated. |
| Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Baseline (Day 1) and 30 days post vaccination | The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined by the MOPA and derived from a cLDA model. |
| Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Baseline (Day 1) and 30 days post vaccination | GMCs for each serotype common in V116 and Pneumovax™23 were measured using PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMC/Day 1 GMC. |
| Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | 30 days post vaccination | Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated. |
| Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | 30 days post vaccination | GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated. |
| Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | 30 days post vaccination | GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated. |
| Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Baseline (Day 1) and 30 days postvaccination | GMTs for the serotypes in V116 and Pneumovax™23 were determined using the MOPA at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. |
| Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Baseline (Day 1) and 30 days post vaccination | GMCs for the serotypes in V116 and Pneumovax™23 were measured by PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMC/Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. |
| Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | 30 days post vaccination | Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated. |
| Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | 30 days post vaccination | Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phase 1: V116 0.5 mL Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1 | 30 |
| Phase 1: V116 1.0 mL Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1 | 30 |
| Phase 1: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1 | 30 |
| Phase 2: V116 Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2 | 254 |
| Phase 2: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2 | 256 |
| Total | 600 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 7 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 2 | 4 |
Baseline characteristics
| Characteristic | Phase 1: V116 0.5 mL | Phase 1: V116 1.0 mL | Phase 1: Pneumovax™23 | Phase 2: V116 | Phase 2: Pneumovax™23 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 37.8 years STANDARD_DEVIATION 7.4 | 34.7 years STANDARD_DEVIATION 8.9 | 35.2 years STANDARD_DEVIATION 8.2 | 61.3 years STANDARD_DEVIATION 7 | 61.2 years STANDARD_DEVIATION 7.3 | 57.5 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 13 Participants | 13 Participants | 107 Participants | 107 Participants | 254 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 17 Participants | 17 Participants | 147 Participants | 147 Participants | 344 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 4 Participants | 4 Participants | 25 Participants | 30 Participants | 69 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 23 Participants | 24 Participants | 224 Participants | 220 Participants | 514 Participants |
| Sex: Female, Male Female | 16 Participants | 19 Participants | 24 Participants | 142 Participants | 140 Participants | 341 Participants |
| Sex: Female, Male Male | 14 Participants | 11 Participants | 6 Participants | 112 Participants | 116 Participants | 259 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 | 0 / 30 | 0 / 30 | 0 / 30 | 1 / 254 | 0 / 256 |
| other Total, other adverse events | 23 / 30 | 24 / 30 | 21 / 30 | 159 / 254 | 133 / 254 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 4 / 254 | 3 / 254 |
Outcome results
Primary
Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
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. Injection-site AEs solicited on the Vaccine Report Card (VRC) were redness/erythema, swelling, and tenderness/pain. The percentage of participants with one or more solicited injection-site AE was assessed.
Time frame: Up to 5 days post-vaccination
Population: All randomized participants enrolled in Phase 1 portion who received study vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site pain | 73.3 Percentage of participants |
| Phase 1: V116 0.5 mL | Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site erythema | 10.0 Percentage of participants |
| Phase 1: V116 0.5 mL | Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site swelling | 20.0 Percentage of participants |
| Phase 1: V116 1.0 mL | Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site pain | 76.7 Percentage of participants |
| Phase 1: V116 1.0 mL | Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site erythema | 23.3 Percentage of participants |
| Phase 1: V116 1.0 mL | Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site swelling | 16.7 Percentage of participants |
| Phase 1: Pneumovax™23 | Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site erythema | 20.0 Percentage of participants |
| Phase 1: Pneumovax™23 | Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site swelling | 13.3 Percentage of participants |
| Phase 1: Pneumovax™23 | Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Injection site pain | 56.7 Percentage of participants |
Comparison: Injection site erythema95% CI: [-29.3, 9]
Comparison: Injection site erythema95% CI: [-18.1, 24.6]
Comparison: Injection site pain95% CI: [-7.7, 39.3]
Comparison: Injection site pain95% CI: [-4.1, 42.1]
Comparison: Injection site swelling95% CI: [-13.2, 26.5]
Comparison: Injection site swelling95% CI: [-16, 22.8]
Primary
Phase 1: Percentage of Participants With a Solicited Systemic AE
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. Systemic AEs solicited on the VRC were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was assessed.
Time frame: Up to 5 days post-vaccination
Population: All randomized participants enrolled in Phase 1 portion who received study vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 1: Percentage of Participants With a Solicited Systemic AE | Headache | 30.0 Percentage of participants |
| Phase 1: V116 0.5 mL | Phase 1: Percentage of Participants With a Solicited Systemic AE | Arthralgia | 16.7 Percentage of participants |
| Phase 1: V116 0.5 mL | Phase 1: Percentage of Participants With a Solicited Systemic AE | Myalgia | 26.7 Percentage of participants |
| Phase 1: V116 0.5 mL | Phase 1: Percentage of Participants With a Solicited Systemic AE | Fatigue | 26.7 Percentage of participants |
| Phase 1: V116 1.0 mL | Phase 1: Percentage of Participants With a Solicited Systemic AE | Arthralgia | 10.0 Percentage of participants |
| Phase 1: V116 1.0 mL | Phase 1: Percentage of Participants With a Solicited Systemic AE | Myalgia | 30.0 Percentage of participants |
| Phase 1: V116 1.0 mL | Phase 1: Percentage of Participants With a Solicited Systemic AE | Fatigue | 26.7 Percentage of participants |
| Phase 1: V116 1.0 mL | Phase 1: Percentage of Participants With a Solicited Systemic AE | Headache | 20.0 Percentage of participants |
| Phase 1: Pneumovax™23 | Phase 1: Percentage of Participants With a Solicited Systemic AE | Myalgia | 13.3 Percentage of participants |
| Phase 1: Pneumovax™23 | Phase 1: Percentage of Participants With a Solicited Systemic AE | Arthralgia | 6.7 Percentage of participants |
| Phase 1: Pneumovax™23 | Phase 1: Percentage of Participants With a Solicited Systemic AE | Headache | 16.7 Percentage of participants |
| Phase 1: Pneumovax™23 | Phase 1: Percentage of Participants With a Solicited Systemic AE | Fatigue | 16.7 Percentage of participants |
Comparison: Fatigue95% CI: [-11.4, 31]
Comparison: Fatigue95% CI: [-11.4, 31]
Comparison: Arthralgia95% CI: [-7.4, 28.3]
Comparison: Arthralgia95% CI: [-13.1, 20.2]
Comparison: Myalgia95% CI: [-7.5, 33.8]
Comparison: Myalgia95% CI: [-4.6, 37.3]
Comparison: Headache95% CI: [-8.5, 34.5]
Comparison: Headache95% CI: [-17.2, 23.8]
Primary
Phase 1: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination were reported.
Time frame: Up to Day 195
Population: All randomized participants enrolled in Phase 1 portion who received study vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: V116 0.5 mL | Phase 1: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | 0.0 Percentage of participants |
| Phase 1: V116 1.0 mL | Phase 1: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | 0.0 Percentage of participants |
| Phase 1: Pneumovax™23 | Phase 1: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | 0.0 Percentage of participants |
95% CI: [-11.5, 11.5]
95% CI: [-11.5, 11.5]
Primary
Phase 2: Percentage of Participants With a Solicited Injection-site AE
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. Injection-site AEs solicited on the Vaccine Report Card (VRC) were redness/erythema, swelling, and tenderness/pain. The percentage of participants with one or more solicited injection-site AE was assessed.
Time frame: Up to 5 days post-vaccination
Population: All randomized participants enrolled in Phase 2 portion who received study vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants With a Solicited Injection-site AE | Injection site erythema | 8.7 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants With a Solicited Injection-site AE | Injection site pain | 46.5 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants With a Solicited Injection-site AE | Injection site swelling | 11.0 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants With a Solicited Injection-site AE | Injection site erythema | 6.7 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants With a Solicited Injection-site AE | Injection site pain | 37.8 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants With a Solicited Injection-site AE | Injection site swelling | 7.9 Percentage of Participants |
Comparison: Injection site erythema95% CI: [-2.8, 6.8]
Comparison: Injection site pain95% CI: [0.1, 17.1]
Comparison: Injection site swelling95% CI: [-2, 8.4]
Primary
Phase 2: Percentage of Participants With a Solicited Systemic AE
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. Systemic AEs solicited on the VRC were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with 1 or more solicited systemic AE was assessed.
Time frame: Up to 5 days post-vaccination
Population: All randomized participants enrolled in Phase 2 portion who received study vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants With a Solicited Systemic AE | Fatigue | 19.3 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants With a Solicited Systemic AE | Arthralgia | 4.3 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants With a Solicited Systemic AE | Myalgia | 11.0 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants With a Solicited Systemic AE | Headache | 16.9 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants With a Solicited Systemic AE | Headache | 13.4 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants With a Solicited Systemic AE | Fatigue | 12.2 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants With a Solicited Systemic AE | Myalgia | 9.4 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants With a Solicited Systemic AE | Arthralgia | 4.3 Percentage of Participants |
Comparison: Fatigue95% CI: [0.8, 13.5]
Comparison: Arthralgia95% CI: [-3.8, 3.8]
Comparison: Myalgia95% CI: [-3.8, 7]
Comparison: Headache95% CI: [-2.7, 9.9]
Primary
Phase 2: Percentage of Participants With Vaccine-related SAEs
An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced at least one SAE that were assessed by the investigator to be at least possibly related to the study vaccination were reported.
Time frame: Up to Day 293
Population: All randomized participants enrolled in Phase 2 portion who received study vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants With Vaccine-related SAEs | 0.0 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants With Vaccine-related SAEs | 0.0 Percentage of Participants |
95% CI: [-1.5, 1.5]
Primary
Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116
GMTs for the serotypes unique to V116 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Time frame: 30 days post vaccination
Population: All randomized participants enrolled in Phase 2 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 6A | 2757.55 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 15A | 11640.00 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 15C | 12611.76 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 16F | 9820.72 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 23A | 11554.45 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 23B | 3137.15 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 24F | 7640.78 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 35B | 15704.65 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 31 | 4461.98 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 23A | 593.91 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 6A | 456.97 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 31 | 127.84 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 15A | 1711.40 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 23B | 105.00 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 15C | 4200.74 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 35B | 1745.16 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 16F | 539.16 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 | Serotype 24F | 238.65 Titers |
Comparison: Serotype 6A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [4.23, 8.62]P-value is estimated from a cLDA model.
Comparison: Serotype 15A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [5.37, 8.62]P-value is estimated from a cLDA model.
Comparison: Serotype 15C. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [2.31, 3.9]P-value is estimated from a cLDA model.
Comparison: Serotype 16F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [12.98, 25.57]P-value is estimated from a cLDA model.
Comparison: Serotype 23A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [12.87, 29.4]P-value is estimated from a cLDA model.
Comparison: Serotype 23B. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [20.72, 43.09]P-value is estimated from a cLDA model.
Comparison: Serotype 24F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [22.83, 44.89]P-value is estimated from a cLDA model.
Comparison: Serotype 31. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [24.25, 50.23]P-value is estimated from a cLDA model.
Comparison: Serotype 35B. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [7.19, 11.26]P-value is estimated from a cLDA model.
Primary
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23
GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the muliplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated.
Time frame: 30 days post vaccination
Population: All randomized participants enrolled in Phase 2 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 3 | 226.26 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 7F | 3535.44 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 19A | 2388.12 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 22F | 8213.56 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 33F | 28129.21 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 8 | 1504.65 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 9N | 10327.15 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 10A | 6062.22 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 11A | 2840.38 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 12F | 2549.45 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 17F | 18394.13 Titers |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 20A | 9305.32 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 17F | 11249.90 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 3 | 226.21 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 9N | 9106.32 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 7F | 2906.76 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 12F | 991.10 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 19A | 2116.13 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 10A | 5092.07 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 22F | 5192.20 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 20A | 5068.03 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 33F | 29974.55 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 11A | 1252.27 Titers |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 8 | 1526.78 Titers |
Comparison: Serotype 3. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [0.82, 1.22]P-value is estimated from a cLDA model.
Comparison: Serotype 7F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [0.95, 1.56]P-value is estimated from a cLDA model.
Comparison: Serotype 19A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [0.9, 1.41]P-value is estimated from a cLDA model.
Comparison: Serotype 22F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [1.16, 2.16]P-value is estimated from a cLDA model.
Comparison: Serotype 33F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [0.71, 1.24]P-value is estimated from a cLDA model.
Comparison: Serotype 8. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [0.8, 1.21]P-value is estimated from a cLDA model.
Comparison: Serotype 9N. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [0.87, 1.47]P-value is estimated from a cLDA model.
Comparison: Serotype 10A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [0.93, 1.52]P-value is estimated from a cLDA model.
Comparison: Serotype 11A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [1.78, 2.9]P-value is estimated from a cLDA model.
Comparison: Serotype 12F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [1.86, 3.55]P-value is estimated from a cLDA model.
Comparison: Serotype 17F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [1.24, 2.16]P-value is estimated from a cLDA model.
Comparison: Serotype 20A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [1.43, 2.36]P-value is estimated from a cLDA model.
Secondary
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG
GMCs for the serotypes in V116 and Pneumovax™23 were measured by PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMC/Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated.
Time frame: Baseline (Day 1) and 30 days post vaccination
Population: All randomized participants enrolled in Phase 1 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 23A | 23.43 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 11A | 2.71 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 22F | 19.51 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 16F | 4.39 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 12F | 10.35 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 15B | 12.54 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 15C | 31.93 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 17F | 19.23 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 31 | 12.83 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 15A | 14.61 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 20A | 10.81 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 33F | 9.33 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 6A | 23.58 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 6C | 6.52 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 24F | 11.18 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 8 | 13.86 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 19A | 4.67 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 3 | 5.36 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 9N | 12.90 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 7F | 8.38 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 23B | 9.03 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 10A | 11.36 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 35B | 9.77 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 23B | 15.56 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 3 | 5.94 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 7F | 16.00 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 19A | 7.28 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 22F | 21.83 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 33F | 16.28 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 8 | 22.89 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 9N | 20.85 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 10A | 16.10 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 11A | 7.18 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 12F | 22.71 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 17F | 22.52 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 20A | 11.18 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 6A | 29.48 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 15A | 28.84 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 15C | 37.55 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 16F | 10.80 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 23A | 22.53 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 24F | 19.44 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 31 | 19.71 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 35B | 11.33 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 6C | 9.48 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 15B | 11.96 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 35B | 0.96 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 16F | 1.69 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 10A | 9.58 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 7F | 7.44 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 23A | 2.75 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 9N | 14.37 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 8 | 25.99 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 23B | 2.66 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 33F | 11.75 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 15B | 8.05 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 24F | 1.26 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 22F | 24.34 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 6C | 2.22 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 20A | 5.60 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 31 | 1.77 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 6A | 5.66 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 17F | 10.07 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 19A | 3.66 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 15A | 3.02 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 12F | 9.75 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 3 | 4.97 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 15C | 7.94 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | Serotype 11A | 5.17 Ratio |
Secondary
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
GMTs for the serotypes in V116 and Pneumovax™23 were determined using the MOPA at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated.
Time frame: Baseline (Day 1) and 30 days postvaccination
Population: All randomized participants enrolled in Phase 1 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 9N | 22.91 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 7F | 15.64 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 19A | 12.26 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 22F | 92.21 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 33F | 17.68 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 8 | 39.67 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 3 | 12.90 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 10A | 12.69 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 11A | 7.46 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 12F | 360.69 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 17F | 36.57 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 20A | 15.67 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 6A | 311.54 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15A | 31.56 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15C | 37.97 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 16F | 16.82 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 23A | 380.08 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 23B | 99.58 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 24F | 14.86 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 31 | 95.53 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 35B | 13.68 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 6C | 41.71 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15B | 78.68 Ratio |
| Phase 1: V116 0.5 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 20B | 3.78 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 6C | 65.05 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 3 | 10.68 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 6A | 375.42 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 23A | 269.90 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 7F | 19.68 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 17F | 37.33 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 35B | 12.56 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 19A | 18.34 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15A | 29.31 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15B | 89.25 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 22F | 81.76 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 12F | 448.73 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 23B | 157.02 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 33F | 34.83 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15C | 58.39 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 20A | 19.20 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 8 | 50.01 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 11A | 8.23 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 20B | 4.17 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 9N | 19.80 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 16F | 25.99 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 24F | 23.51 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 10A | 18.21 Ratio |
| Phase 1: V116 1.0 mL | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 31 | 94.51 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 10A | 10.35 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 11A | 7.64 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 12F | 162.71 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 17F | 20.54 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 31 | 3.23 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 20A | 14.91 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15B | 33.11 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 6A | 20.95 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15A | 5.53 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 35B | 1.73 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15C | 10.58 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 20B | 5.01 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 16F | 4.30 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 3 | 10.01 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 7F | 34.18 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 23A | 17.52 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 19A | 14.92 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 6C | 2.82 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 22F | 32.64 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 33F | 20.24 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 23B | 5.39 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 8 | 72.24 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 9N | 27.38 Ratio |
| Phase 1: Pneumovax™23 | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 24F | 1.24 Ratio |
Secondary
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23
Serotype-specific pneumococcal IgG antibodies were measured using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Time frame: 30 days post vaccination
Population: All randomized participants enrolled in Phase 1 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 3 | 0.78 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 7F | 3.33 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 19A | 6.29 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 22F | 5.27 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 33F | 8.64 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 8 | 11.33 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 9N | 5.40 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 10A | 8.90 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 11A | 4.50 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 12F | 1.03 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 17F | 11.54 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 20A | 16.44 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 20A | 19.13 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 3 | 0.97 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 9N | 8.60 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 11A | 9.44 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 7F | 6.39 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 8 | 17.62 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 17F | 15.71 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 19A | 10.27 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 10A | 13.13 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 33F | 15.19 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 22F | 7.14 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 12F | 2.13 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 22F | 7.16 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 33F | 11.51 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 12F | 0.99 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 8 | 17.80 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 9N | 5.26 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 10A | 7.15 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 17F | 5.48 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 3 | 0.86 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 7F | 2.98 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 11A | 5.93 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 19A | 4.93 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 20A | 9.97 μg/mL |
Comparison: Serotype 9N95% CI: [0.57, 1.85]
Comparison: Serotype 9N95% CI: [0.9, 2.97]
Comparison: Serotype 10A95% CI: [0.67, 2.32]
Comparison: Serotype 10A95% CI: [0.98, 3.45]
Comparison: Serotype 11A95% CI: [0.42, 1.38]
Comparison: Serotype 11A95% CI: [0.87, 2.91]
Comparison: Serotype 12F95% CI: [0.5, 2.17]
Comparison: Serotype 12F95% CI: [1.02, 4.5]
Comparison: Serotype 17F95% CI: [1.21, 3.68]
Comparison: Serotype 17F95% CI: [1.64, 5.03]
Comparison: Serotype 20A95% CI: [0.93, 2.93]
Comparison: Serotype 20A95% CI: [1.07, 3.43]
Comparison: Serotype 395% CI: [0.58, 1.42]
Comparison: Serotype 395% CI: [0.71, 1.76]
Comparison: Serotype 7F95% CI: [0.63, 1.99]
Comparison: Serotype 7F95% CI: [1.19, 3.84]
Comparison: Serotype 19A95% CI: [0.74, 2.21]
Comparison: Serotype 19A95% CI: [1.19, 3.63]
Comparison: Serotype 22F95% CI: [0.37, 1.46]
Comparison: Serotype 22F95% CI: [0.5, 2]
Comparison: Serotype 33F95% CI: [0.4, 1.41]
Comparison: Serotype 33F95% CI: [0.7, 2.48]
Comparison: Serotype 895% CI: [0.37, 1.08]
Comparison: Serotype 895% CI: [0.58, 1.69]
Secondary
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116
Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Time frame: 30 days post vaccination
Population: All randomized participants enrolled in Phase 1 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 16F | 1.27 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 35 | 11.89 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 23B | 5.52 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 23A | 4.02 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 6A | 6.32 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 31 | 2.68 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 15C | 16.33 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 15A | 8.87 μg/mL |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 24F | 3.39 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 23A | 4.03 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 6A | 8.08 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 15A | 15.66 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 15C | 18.26 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 16F | 2.44 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 23B | 7.67 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 24F | 6.79 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 31 | 3.99 μg/mL |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 35 | 16.09 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 15C | 3.71 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 6A | 1.47 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 24F | 0.42 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 15A | 1.76 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 35 | 1.29 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 23A | 0.43 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 16F | 0.37 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 31 | 0.29 μg/mL |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 | Serotype 23B | 1.61 μg/mL |
Comparison: Serotype 6A95% CI: [1.99, 9.25]
Comparison: Serotype 6A95% CI: [2.53, 11.91]
Comparison: Serotype 15A95% CI: [2.59, 9.85]
Comparison: Serotype 15A95% CI: [4.55, 17.5]
Comparison: Serotype 15C95% CI: [2.38, 8.15]
Comparison: Serotype 15C95% CI: [2.64, 9.16]
Comparison: Serotype 16F95% CI: [1.97, 5.91]
Comparison: Serotype 16F95% CI: [3.78, 11.45]
Comparison: Serotype 23A95% CI: [4.35, 20.4]
Comparison: Serotype 23A95% CI: [4.34, 20.62]
Comparison: Serotype 23B95% CI: [1.95, 6.05]
Comparison: Serotype 24F95% CI: [3.36, 19.35]
Comparison: Serotype 23B95% CI: [2.69, 8.45]
Comparison: Serotype 24F95% CI: [6.68, 39.01]
Comparison: Serotype 3195% CI: [4.93, 16.95]
Comparison: Serotype 3195% CI: [7.28, 25.32]
Comparison: Serotype 35B95% CI: [5.56, 15.36]
Comparison: Serotype 35B95% CI: [7.49, 20.87]
Secondary
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23
GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Time frame: 30 days post vaccination
Population: All randomized participants enrolled in Phase 1 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 3 | 242.35 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 7F | 4503.32 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 19A | 3312.61 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 22F | 21336.23 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 33F | 62540.43 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 8 | 1830.31 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 9N | 28204.72 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 10A | 10338.92 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 11A | 2531.25 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 12F | 5171.95 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 17F | 48838.60 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 20A | 13910.60 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 20A | 17799.33 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 3 | 259.17 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 9N | 26659.08 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 11A | 3152.05 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 7F | 5672.08 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 8 | 2321.18 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 17F | 51152.97 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 19A | 4595.55 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 10A | 12377.52 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 33F | 137389.68 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 22F | 26003.97 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 12F | 7279.62 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 22F | 12905.25 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 33F | 72703.24 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 12F | 3036.31 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 8 | 2598.16 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 9N | 24483.35 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 10A | 6623.80 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 17F | 24816.34 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 3 | 243.66 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 7F | 5122.36 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 11A | 2836.72 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 19A | 3475.22 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 | Serotype 20A | 11430.20 Titers |
Comparison: Serotype 395% CI: [0.67, 1.47]
Comparison: Serotype 395% CI: [0.72, 1.57]
Comparison: Serotype 7F95% CI: [0.54, 1.42]
Comparison: Serotype 7F95% CI: [0.68, 1.8]
Comparison: Serotype 19A95% CI: [0.59, 1.54]
Comparison: Serotype 19A95% CI: [0.81, 2.15]
Comparison: Serotype 22F95% CI: [0.85, 3.23]
Comparison: Serotype 22F95% CI: [1.03, 3.96]
Comparison: Serotype 33F95% CI: [0.44, 1.67]
Comparison: Serotype 33F95% CI: [0.97, 3.69]
Comparison: Serotype 895% CI: [0.46, 1.08]
Comparison: Serotype 895% CI: [0.58, 1.38]
Comparison: Serotype 9N95% CI: [0.62, 2.15]
Comparison: Serotype 9N95% CI: [0.58, 2.04]
Comparison: Serotype 10A95% CI: [0.9, 2.71]
Comparison: Serotype 10A95% CI: [1.08, 3.23]
Comparison: Serotype 11A95% CI: [0.53, 1.49]
Comparison: Serotype 11A95% CI: [0.66, 1.87]
Comparison: Serotype 12F95% CI: [0.89, 3.27]
Comparison: Serotype 12F95% CI: [1.24, 4.62]
Comparison: Serotype 17F95% CI: [1.16, 3.34]
Comparison: Serotype 17F95% CI: [1.21, 3.51]
Comparison: Serotype 20A95% CI: [0.77, 1.91]
Comparison: Serotype 20A95% CI: [0.99, 2.45]
Secondary
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23
GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Time frame: 30 days post vaccination
Population: All randomized participants enrolled in Phase 1 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 16F | 11120.97 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 35B | 21103.18 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 23B | 5258.43 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 23A | 26267.17 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 6A | 7182.41 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 31 | 7417.79 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 15C | 20743.02 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 15A | 19337.39 Titers |
| Phase 1: V116 0.5 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 24F | 7593.39 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 23A | 36793.08 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 6A | 7407.66 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 15A | 24580.49 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 15C | 27242.11 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 16F | 17201.69 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 23B | 8684.75 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 24F | 11867.21 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 31 | 7453.48 Titers |
| Phase 1: V116 1.0 mL | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 35B | 23826.47 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 15C | 9728.58 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 6A | 513.88 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 24F | 381.95 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 15A | 2615.98 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 35B | 3044.94 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 23A | 1908.80 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 16F | 2931.40 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 31 | 128.36 Titers |
| Phase 1: Pneumovax™23 | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 | Serotype 23B | 220.48 Titers |
Comparison: Serotype 6A95% CI: [5.9, 33.1]
Comparison: Serotype 6A95% CI: [6.05, 34.35]
Comparison: Serotype 15A95% CI: [4.29, 12.75]
Comparison: Serotype 15A95% CI: [5.42, 16.28]
Comparison: Serotype 15C95% CI: [1.25, 3.63]
Comparison: Serotype 15C95% CI: [1.64, 4.79]
Comparison: Serotype 16F95% CI: [1.88, 7.67]
Comparison: Serotype 16F95% CI: [2.88, 11.94]
Comparison: Serotype 23A95% CI: [5.68, 33.32]
Comparison: Serotype 23A95% CI: [7.91, 47]
Comparison: Serotype 23B95% CI: [8.64, 65.82]
Comparison: Serotype 23B95% CI: [14.15, 109.65]
Comparison: Serotype 24F95% CI: [9.03, 43.74]
Comparison: Serotype 24F95% CI: [13.98, 69.03]
Comparison: Serotype 3195% CI: [25.1, 134.33]
Comparison: Serotype 3195% CI: [25.15, 132.78]
Comparison: Serotype 35B95% CI: [4.45, 10.8]
Comparison: Serotype 35B95% CI: [5, 12.24]
Secondary
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
GMTs for the serotypes in V116 and Pneumovax™23 were determined using the MOPA at baseline and at 30 days post vaccination and derived from a cLDA model. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMT/Day 1 GMT.
Time frame: Baseline (Day 1) and 30 days post vaccination
Population: All randomized participants enrolled in Phase 2 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 9N | 33.51 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 7F | 31.07 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 19A | 13.05 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 22F | 52.66 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 33F | 13.47 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 8 | 39.06 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 3 | 12.03 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 10A | 12.34 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 11A | 33.21 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 12F | 150.08 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 17F | 40.71 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 20A | 20.48 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 6A | 79.16 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15A | 26.66 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15C | 65.18 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 16F | 56.50 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 23A | 237.14 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 23B | 97.79 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 24F | 48.78 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 31 | 92.00 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 35B | 12.41 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 6C | 19.41 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15B | 24.32 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 20B | 7.21 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15B | 25.73 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 3 | 10.96 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 6A | 11.30 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 7F | 22.52 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 24F | 1.52 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 19A | 10.26 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15A | 3.93 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 22F | 46.34 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 6C | 4.24 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 33F | 14.04 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 15C | 23.73 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 8 | 40.06 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 31 | 3.25 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 9N | 29.38 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 16F | 3.54 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 10A | 8.12 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 20B | 5.35 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 11A | 12.29 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 23A | 10.65 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 12F | 57.03 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 35B | 1.53 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 17F | 25.68 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 23B | 4.62 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | Serotype 20A | 12.16 Ratio |
Secondary
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG
GMCs for each serotype common in V116 and Pneumovax™23 were measured using PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMC/Day 1 GMC.
Time frame: Baseline (Day 1) and 30 days post vaccination
Population: All randomized participants enrolled in Phase 2 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 3 | 5.23 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 7F | 9.96 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 19A | 5.29 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 22F | 12.45 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 33F | 9.94 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 8 | 14.53 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 9N | 17.77 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 10A | 17.32 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 11A | 7.71 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 12F | 13.72 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 17F | 20.26 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 20A | 14.95 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 6A | 13.35 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 15A | 23.94 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 15C | 22.35 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 16F | 12.42 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 23A | 20.27 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 23B | 13.50 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 24F | 25.20 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 31 | 15.89 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 35B | 18.72 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 6C | 5.78 Ratio |
| Phase 1: V116 0.5 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 15B | 9.95 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 20A | 6.30 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 3 | 4.56 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 23B | 2.51 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 7F | 8.28 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 6A | 3.56 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 19A | 4.12 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 35B | 1.04 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 22F | 9.04 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 15A | 3.02 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 33F | 11.63 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 24F | 1.08 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 8 | 15.51 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 15C | 7.28 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 9N | 11.80 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 15B | 8.87 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 10A | 9.29 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 16F | 1.51 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 11A | 4.72 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 31 | 1.62 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 12F | 6.14 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 23A | 2.66 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 17F | 11.11 Ratio |
| Phase 1: V116 1.0 mL | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | Serotype 6C | 1.67 Ratio |
Secondary
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination
The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined by the MOPA and derived from a cLDA model.
Time frame: Baseline (Day 1) and 30 days post vaccination
Population: All randomized participants enrolled in Phase 2 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 9N | 77.3 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 7F | 74.2 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 19A | 66.9 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 22F | 81.3 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 33F | 68.4 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 8 | 80.9 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 3 | 74.8 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 10A | 59.9 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 11A | 80.3 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 12F | 90.2 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 17F | 85.2 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 20A | 83.6 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 6A | 83.2 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 15A | 86.6 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 15C | 88.5 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 16F | 85.4 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 23A | 93.3 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 23B | 87.4 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 24F | 82.8 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 31 | 86.6 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 35B | 73.2 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 6C | 58.4 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 15B | 71.0 Percentage of Participants |
| Phase 1: V116 0.5 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 20B | 52.8 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 15B | 75.3 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 3 | 75.7 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 6A | 58.8 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 7F | 77.0 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 24F | 15.3 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 19A | 67.1 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 15A | 39.3 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 22F | 79.3 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 6C | 33.8 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 33F | 75.7 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 15C | 71.0 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 8 | 85.5 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 31 | 30.1 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 9N | 79.5 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 16F | 30.2 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 10A | 55.2 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 20B | 44.1 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 11A | 62.9 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 23A | 48.7 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 12F | 82.9 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 35B | 11.3 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 17F | 80.9 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 23B | 40.4 Percentage of Participants |
| Phase 1: V116 1.0 mL | Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination | Serotype 20A | 69.4 Percentage of Participants |
Secondary
Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23
Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Time frame: 30 days post vaccination
Population: All randomized participants enrolled in Phase 2 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 3 | 0.78 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 7F | 4.98 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 19A | 7.77 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 22F | 3.81 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 33F | 11.89 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 8 | 9.86 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 9N | 7.18 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 10A | 10.78 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 11A | 5.16 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 12F | 1.56 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 17F | 12.85 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 20A | 20.59 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 17F | 7.06 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 3 | 0.72 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 9N | 5.51 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 7F | 4.07 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 12F | 0.68 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 19A | 6.26 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 10A | 5.89 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 22F | 2.79 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 20A | 9.09 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 33F | 13.82 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 11A | 3.35 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 | Serotype 8 | 10.30 μg/mL |
Comparison: Serotype 3. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [0.9, 1.3]P-value is estimated from a cLDA model.
Comparison: Serotype 7F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [0.99, 1.52]P-value is estimated from a cLDA model.
Comparison: Serotype 19A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [1.02, 1.52]P-value is estimated from a cLDA model.
Comparison: Serotype 22F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [1.06, 1.75]P-value is estimated from a cLDA model.
Comparison: Serotype 33F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [0.69, 1.06]P-value is estimated from a cLDA model.
Comparison: Serotype 8. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [0.78, 1.18]P-value is estimated from a cLDA model.
Comparison: Serotype 9N. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [1.04, 1.64]P-value is estimated from a cLDA model.
Comparison: Serotype 10A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [1.44, 2.32]P-value is estimated from a cLDA model.
Comparison: Serotype 11A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [1.27, 1.86]P-value is estimated from a cLDA model.
Comparison: Serotype 12F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [1.75, 3.04]P-value is estimated from a cLDA model.
Comparison: Serotype 17F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [1.49, 2.22]P-value is estimated from a cLDA model.
Comparison: Serotype 20A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [1.81, 2.83]P-value is estimated from a cLDA model.
Secondary
Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116
Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Time frame: 30 days post vaccination
Population: All randomized participants enrolled in Phase 2 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 15A | 13.14 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 23B | 5.18 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 16F | 2.17 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 24F | 6.11 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 15C | 11.91 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 31 | 3.15 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 23A | 3.32 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 35B | 24.55 μg/mL |
| Phase 1: V116 0.5 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 6A | 4.06 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 35B | 1.34 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 6A | 1.07 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 15A | 1.71 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 15C | 3.62 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 16F | 0.25 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 23A | 0.42 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 23B | 0.92 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 24F | 0.25 μg/mL |
| Phase 1: V116 1.0 mL | Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 | Serotype 31 | 0.31 μg/mL |
Comparison: Serotype 6A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [2.95, 4.84]P-value is estimated from a cLDA model.
Comparison: Serotype 15A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [6.12, 9.64]P-value is estimated from a cLDA model.
Comparison: Serotype 15C. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [2.6, 4.17]P-value is estimated from a cLDA model.
Comparison: Serotype 16F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [7.19, 10.41]P-value is estimated from a cLDA model.
Comparison: Serotype 23A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) modelp-value: <0.00195% CI: [6.2, 9.9]P-value is estimated from a cLDA model.
Comparison: Serotype 23B. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [4.53, 6.94]P-value is estimated from a cLDA model.
Comparison: Serotype 24F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [19.35, 29.74]P-value is estimated from a cLDA model.
Comparison: Serotype 31. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [8.32, 12.33]P-value was estimated from a cLDA model.
Comparison: Serotype 35B. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.p-value: <0.00195% CI: [15.59, 21.45]P-value is estimated from a cLDA model.