| 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. | All randomized participants enrolled in Phase 1 portion who received study vaccination | Posted | | Number | | Percentage of participants | | Up to 5 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: V116 0.5 mL | Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1 | | OG001 | Phase 1: V116 1.0 mL | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1 | | OG002 | Phase 1: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1 |
| | | Title | Denominators | Categories |
|---|
| Injection site erythema | | | Title | Measurements |
|---|
| - OG00010.0
- OG00123.3
- OG00220.0
|
| | Injection site pain | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Difference in Percentage | -10.0 | | | 2-Sided | 95 | -29.3 | 9.0 | | | Phase 1: V116 0.5 mL minus Phase 1: Pneumovaxâ„¢23 | | Other | Estimated difference and CI are calculated based on the Miettinen & Nurminen method | | |
|
| 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. | All randomized participants enrolled in Phase 1 portion who received study vaccination | Posted | | Number | | Percentage of participants | | Up to 5 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: V116 0.5 mL | Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1 | | OG001 | Phase 1: V116 1.0 mL | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1 | | OG002 | Phase 1: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1 |
| |
| 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. | All randomized participants enrolled in Phase 1 portion who received study vaccination | Posted | | Number | | Percentage of participants | | Up to Day 195 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: V116 0.5 mL | Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1 | | OG001 | Phase 1: V116 1.0 mL | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1 | | OG002 | Phase 1: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1 |
| |
| 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. | All randomized participants enrolled in Phase 2 portion who received study vaccination | Posted | | Number | | Percentage of Participants | | Up to 5 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 2: V116 | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2 | | OG001 | Phase 2: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2 |
| |
| 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. | All randomized participants enrolled in Phase 2 portion who received study vaccination | Posted | | Number | | Percentage of Participants | | Up to 5 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 2: V116 | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2 | | OG001 | Phase 2: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2 |
| |
| 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. | All randomized participants enrolled in Phase 2 portion who received study vaccination | Posted | | Number | | Percentage of Participants | | Up to Day 293 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2: V116 | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2 | | OG001 | Phase 2: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2 |
| |
| Primary | Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovaxâ„¢23 | GMTs for the serotypes common to V116 and Pneumovaxâ„¢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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 30 days post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 2: V116 | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2 | | OG001 | Phase 2: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2 |
| |
| 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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 30 days post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 2: V116 | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2 | | OG001 | Phase 2: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2 |
| |
| 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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | 30 days post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: V116 0.5 mL | Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1 | | OG001 | Phase 1: V116 1.0 mL | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1 | | OG002 | Phase 1: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1 |
| |
| 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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | 30 days post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: V116 0.5 mL | Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1 | | OG001 | Phase 1: V116 1.0 mL | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1 | | OG002 | Phase 1: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1 |
| |
| Secondary | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovaxâ„¢23 | GMTs for the serotypes common to V116 and Pneumovaxâ„¢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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 30 days post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: V116 0.5 mL | Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1 | | OG001 | Phase 1: V116 1.0 mL | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1 | | OG002 | Phase 1: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1 |
| |
| Secondary | Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovaxâ„¢23 | GMTs for the serotypes common to V116 and Pneumovaxâ„¢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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 30 days post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: V116 0.5 mL | Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1 | | OG001 | Phase 1: V116 1.0 mL | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1 | | OG002 | Phase 1: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1 |
| |
| Secondary | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | GMTs for the serotypes in V116 and Pneumovaxâ„¢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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline (Day 1) and 30 days postvaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: V116 0.5 mL | Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1 | | OG001 | Phase 1: V116 1.0 mL | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1 | | OG002 | Phase 1: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1 |
| |
| Secondary | Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG | GMCs for the serotypes in V116 and Pneumovaxâ„¢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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline (Day 1) and 30 days post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: V116 0.5 mL | Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1 | | OG001 | Phase 1: V116 1.0 mL | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1 | | OG002 | Phase 1: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1 |
| |
| 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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | 30 days post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 2: V116 | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2 | | OG001 | Phase 2: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2 |
| |
| 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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | 30 days post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 2: V116 | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2 | | OG001 | Phase 2: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2 |
| |
| Secondary | Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | GMTs for the serotypes in V116 and Pneumovaxâ„¢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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline (Day 1) and 30 days post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 2: V116 | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2 | | OG001 | Phase 2: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2 |
| |
| Secondary | Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG | GMCs for each serotype common in V116 and Pneumovaxâ„¢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. | 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 | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline (Day 1) and 30 days post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 2: V116 | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2 | | OG001 | Phase 2: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2 |
| |
| 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. | 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 | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline (Day 1) and 30 days post vaccination | | | | ID | Title | Description |
|---|
| OG000 | Phase 2: V116 | Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2 | | OG001 | Phase 2: Pneumovaxâ„¢23 | Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2 |
| |