A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)

Merck Sharp & Dohme LLC1,080 enrolled

Overview

This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza Vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) for V116 and hemagglutination inhibition (HAI) geometric mean titers (GMTs) for QIV, at 30 days postvaccination.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,080

Conditions

Pneumonia, Pneumococcal

Interventions

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Any underlying chronic conditions were assessed to be in stable condition per the investigator's judgment * Females: Not pregnant or a breast feeding and not a woman of childbearing potential (WOCBP) or a WOCBP agrees to use contraception or remain abstinent Exclusion Criteria: * History of IPD or other culture-positive pneumococcal disease * Known or suspected impairment of immunological function * Receipt of systemic corticosteroids or immunosuppressive therapy * Received any pneumococcal vaccine \<12 months prior to enrollment * Prior administration of PCV15 or PCV20 * Received any influenza vaccine \<6 months prior to enrollment

Locations (56)

Central Phoenix Medical Clinic-Synexus Clinical Research US ( Site 0012)

Phoenix, Arizona, United States

Hope Clinical Research, Inc. ( Site 0070)

Canoga Park, California, United States

Paradigm Clinical Research Centers, Inc ( Site 0024)

La Mesa, California, United States

Catalina Research Institute, LLC ( Site 0067)

Montclair, California, United States

WR- PRI, LLC ( Site 0044)

Newport Beach, California, United States

Outcomes

Primary Outcomes

Number of Participants With Solicited Injection-site Adverse Events (AEs)

An adverse event (AE) is any untoward medical occurrence in a patient or 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 erythema, pain, and swelling.

Time frame: Up to 5 days post-vaccination

Number of Participants With Solicited Systemic AEs

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs include fatigue, headache, myalgia, and pyrexia.

Time frame: Up to 5 days post-vaccination

Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)

A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination are summarized.

Time frame: Up to ~6 months postvaccination with V116

Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses

OPA for the serotypes in V116 were determined using a multiplexed opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs (GMTs) (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated.

Time frame: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)

GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI)

GMTs for the 4 strains contained in QIV vaccine were determined using an HAI assay.

Time frame: Day 30

Secondary Outcomes

Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)

The GMCs of serotype-specific IgG for the serotypes contained in V116 were determined using a pneumococcal electrochemiluminescence (Pn ECL) assay.

Time frame: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)

Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA

OPA for the serotypes in V116 were determined using a MOPA. GMFR ratio is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.

Time frame: Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group)

GMFR Ratio of Serotype-specific IgG

GMFR ratios for the serotype-specific IgG in V116 were determined using a Pn ECL.

Time frame: Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group)

GMFR in Influenza Strain-specific HAI

Activity for the 4 strains contained in QIV vaccine was determined using an HAI assay. GMFR is GMT 30 days after vaccination / GMT at Baseline.

Time frame: Day 1 (Baseline) and Day 30 (Postvaccination)

Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40

The percentage of participants with seroconversion is presented. Activity for the 4 strains contained in QIV vaccine was determined using an HAI assay.

Time frame: Day 30