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NCT05464420 Clinical Trial

A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)

Pneumococcal Disease Clinical Trial

Official title:
A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05464420
Other study ID # V116-004
Secondary ID 2022-000265-41
Status Completed
Phase Phase 3
First received
Last updated
Start date August 12, 2022
Est. completion date May 25, 2023

Study information
Verified date May 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age. The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.

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Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• V116
Pneumococcal 21-valent conjugate vaccine with 4 µg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
• PPSV23
Pneumococcal 23-valent conjugate 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
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Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Denmark,  Finland,  Israel,  Poland,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Following Vaccination With Separate V116 Lots An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included pain/tenderness, redness/erythema, and swelling. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Up to 5 days
Primary Percentage of Participants With Solicited Injection-site AEs Following Vaccination: Combined Lots of V116 or PPSV23 An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included pain/tenderness, redness/erythema, and swelling. Per the statistical analysis plan, within group method of dispersion (MOD) were planned or calculated. Up to 5 days
Primary Percentage of Participants With Solicited Systemic AEs Following Vaccination With Separate V116 Lots An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included headache, muscle aches/myalgia, tiredness/fatigue, and pyrexia. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Up to 5 days
Primary Percentage of Participants With Solicited Systemic AEs Following Vaccination: Combined Lots of V116 or PPSV23 An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included headache, muscle aches/myalgia, tiredness/fatigue, and pyrexia. Per the statistical analysis plan, within group method of dispersion (MOD) were planned or calculated. Up to 5 days
Primary Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) Following Vaccination With Separate V116 Lots An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Up to 194 days
Primary Percentage of Participants With Vaccine-related SAEs Following Vaccination: Combined Lots of V116 or PPSV23 An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per the statistical analysis plan, within group MOD were planned or calculated. Up to 194 days
Primary Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Day 30
Secondary GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CI were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated. Day 30
Secondary Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype-specific IgG concentrations for all serotypes in V116 following vaccination were determined 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 and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Day 30
Secondary GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype-specific IgG concentrations for all serotypes in V116 following vaccination were determined 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. Day 30
Secondary Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype-specific OPA GMFR for all serotypes in V116 following vaccination were determined using MOPA. The GMFR of each pneumococcal serotype was calculated as Day 30 GMT/Day 1 GMT. The 95% CIs were calculated based on based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Baseline (Day 1) and Day 30
Secondary Percentage of Participants With =4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype-specific OPA titer were determined using MOPA. Percentage of participants with a =4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination were reported. The 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Baseline (Day 1) and Day 30
Secondary GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype-specific IgG GMFR for all serotypes in V116 following vaccination were determined using PnECL. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMC/Day 1 GMC. The 95% CIs were calculated based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Baseline (Day 1) and Day 30
Secondary Percentage of Participants With =4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype-specific IgG concentrations were determined using PnECL. Percentage of participants with a =4-fold rise in serotype-specific IgG for all serotypes in V116 were reported. The 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Baseline (Day 1) and Day 30
Secondary GMTs of Serotype-specific OPA for Cross-reactive Serotypes Following Vaccination With Separate V116 Lots Serotype-specific OPA titers for cross-reactive serotypes (6A, 6C, 15B, and 15C) were determined using MOPA. The 95% CIs for serotype-specific OPA GMTs were calculated based on based on the t-distribution. Per protocol, within-group CIs were not calculated. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Day 30
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