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)
- Registration Number
- NCT05464420
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2162
- Has underlying chronic conditions but assessed to be stable as per investigator
- Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator
- Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 1 (Day 1)
- Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
- Has a coagulation disorder contraindicating intramuscular vaccination
- Has a recent illness with fever
- Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
- Is expected to receive any pneumococcal vaccine during the study outside of the protocol
- Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥14 days before receipt of study vaccine
- Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
- Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of study vaccine
- Has received any live vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live vaccine ≤30 days after receipt of study vaccine
- Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V116 Lot 2 V116 Participants will receive a single 0.5 mL IM dose of V116 Lot 2 on Day 1. V116 Lot 1 V116 Participants will receive a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1. V116 Lot 3 V116 Participants will receive a single 0.5 mL IM dose of V116 Lot 3 on Day 1. PPSV23 PPSV23 Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Solicited Systemic AEs Following Vaccination With Separate V116 Lots Up to 5 days 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.
Percentage of Participants With Solicited Systemic AEs Following Vaccination: Combined Lots of V116 or PPSV23 Up to 5 days 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, no within group method of dispersion (MOD) were planned or calculated.
Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Following Vaccination With Separate V116 Lots Up to 5 days 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.
Percentage of Participants With Solicited Injection-site AEs Following Vaccination: Combined Lots of V116 or PPSV23 Up to 5 days 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, no within group method of dispersion (MOD) were planned or calculated.
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Day 30 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.
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) Following Vaccination With Separate V116 Lots Up to 194 days 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.
Percentage of Participants With Vaccine-related SAEs Following Vaccination: Combined Lots of V116 or PPSV23 Up to 194 days 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, no within group MOD were planned or calculated.
- Secondary Outcome Measures
Name Time Method GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Day 30 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.
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Baseline (Day 1) and Day 30 Serotype-specific OPA titer were determined using MOPA. The 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.
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Baseline (Day 1) and Day 30 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.
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Day 30 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.
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Baseline (Day 1) and Day 30 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.
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Baseline (Day 1) and Day 30 Serotype-specific IgG concentrations were determined using PnECL. The 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.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Day 30 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.
GMTs of Serotype-specific OPA for Cross-reactive Serotypes Following Vaccination With Separate V116 Lots Day 30 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, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Trial Locations
- Locations (72)
Desert Clinical Research/ CCT Research ( Site 0019)
🇺🇸Mesa, Arizona, United States
Fiel Family and Sports Medicine, PC/CCT Research ( Site 0008)
🇺🇸Tempe, Arizona, United States
Baptist Health Center For Clinical Research ( Site 0015)
🇺🇸Little Rock, Arkansas, United States
Valley Clinical Trials, Inc. ( Site 0023)
🇺🇸Northridge, California, United States
Artemis Institute for Clinical Research ( Site 0027)
🇺🇸San Diego, California, United States
Millennium Clinical Trials ( Site 0004)
🇺🇸Simi Valley, California, United States
Diablo Clinical Research, Inc. ( Site 0022)
🇺🇸Walnut Creek, California, United States
Lynn Institute of Denver ( Site 0003)
🇺🇸Aurora, Colorado, United States
Indago Research & Health Center, Inc ( Site 0011)
🇺🇸Hialeah, Florida, United States
L&C Professional Medical Research Institute ( Site 0012)
🇺🇸Miami, Florida, United States
Scroll for more (62 remaining)Desert Clinical Research/ CCT Research ( Site 0019)🇺🇸Mesa, Arizona, United States