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)

A Phase 3 Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older

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 Overview

• Status: Completed
• Conditions: Pneumonia, Pneumococcal
• Intervention / Treatment: Biological: QIV; Biological: Matching Placebo for V116; Biological: V116

• Study Type: Interventional
• Enrollment (Actual): 1080
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Central Phoenix Medical Clinic-Synexus Clinical Research US ( Site 0012)
  • California
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, Inc. ( Site 0070)
    • La Mesa, California, United States, 91942
      • Paradigm Clinical Research Centers, Inc ( Site 0024)
    • Montclair, California, United States, 91763
      • Catalina Research Institute, LLC ( Site 0067)
    • Newport Beach, California, United States, 92620
      • WR- PRI, LLC ( Site 0044)
    • North Hollywood, California, United States, 91606
      • Carbon Health - North Hollywood - NoHo West ( Site 0016)
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc. ( Site 0002)
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research ( Site 0023)
    • San Diego, California, United States, 92120
      • WR-MCCR, LLC ( Site 0033)
    • San Diego, California, United States, 92123
      • California Research Foundation ( Site 0005)
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc. ( Site 0020)
  • Florida
    • Hallandale, Florida, United States, 33009
      • Velocity Clinical Research, Hallandale Beach ( Site 0064)
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc ( Site 0029)
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research, LLC ( Site 0013)
    • Jupiter, Florida, United States, 33458
      • Health Awareness ( Site 0034)
    • Melbourne, Florida, United States, 32934
      • Optimal Research ( Site 0008)
    • Miami, Florida, United States, 33135
      • Suncoast Research Group-Clinical Department ( Site 0062)
    • Miami, Florida, United States, 33173
      • Suncoast Research Associates ( Site 0041)
    • Miami, Florida, United States, 33186
      • Alpha Science Research ( Site 0042)
    • Miami Lakes, Florida, United States, 33014
      • Lakes Research ( Site 0063)
    • West Palm Beach, Florida, United States, 33407
      • Triple O Research Institute, P.A ( Site 0054)
  • Georgia
    • Canton, Georgia, United States, 30114
      • East Coast Institute for Research - Canton ( Site 0004)
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta ( Site 0068)
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Synexus Clinical Research US, Inc. ( Site 0072)
    • Flossmoor, Illinois, United States, 60422
      • Healthcare Research Network - Chicago ( Site 0014)
  • Maryland
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical Group ( Site 0035)
  • Missouri
    • St Louis, Missouri, United States, 63042
      • Healthcare Research Network - St. Louis ( Site 0011)
    • St Louis, Missouri, United States, 63141
      • Radiant Research ( Site 0073)
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Alivation Research-Primary Care ( Site 0066)
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • WR-CRCN, LLC ( Site 0018)
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Axces Research ( Site 0037)
  • New York
    • Cortland, New York, United States, 13045
      • Smith Allergy and Asthma Specialists-Certified Research Associates ( Site 0019)
    • New York, New York, United States, 10017
      • Synexus Clinical Research US, Inc - New York ( Site 0053)
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc. ( Site 0055)
    • Vestal, New York, United States, 13850
      • Meridian Clinical Research, LLC ( Site 0032)
  • North Carolina
    • Fayetteville, North Carolina, United States, 28303
      • Carolina Institute for Clinical Research ( Site 0047)
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research Associates ( Site 0040)
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center ( Site 0071)
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research, Medford ( Site 0060)
  • Pennsylvania
    • Hatboro, Pennsylvania, United States, 19040
      • Hatboro Medical Associates / CCT Research ( Site 0065)
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research, Providence ( Site 0021)
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Velocity Clinical Research, Anderson ( Site 0077)
    • Columbia, South Carolina, United States, 29204
      • Velocity Clinical Research, Columbia ( Site 0058)
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Holston Medical Group-Clinical Research ( Site 0028)
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group-Clinical Research ( Site 0009)
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates Inc ( Site 0026)
  • Texas
    • Austin, Texas, United States, 78705
      • Optimal Research ( Site 0015)
    • Brownsville, Texas, United States, 78526
      • Headlands Research - Brownsville ( Site 0069)
    • Fort Worth, Texas, United States, 76135
      • Benchmark Research ( Site 0025)
    • Houston, Texas, United States, 77042
      • New Horizon Medical Group ( Site 0078)
    • Houston, Texas, United States, 77065
      • Innovative Medical Research of Texas ( Site 0079)
    • Pearland, Texas, United States, 77584
      • LinQ Research ( Site 0074)
  • Utah
    • Murray, Utah, United States, 84123
      • Synexus Clinical Research US, Inc. ( Site 0001)
    • South Jordan, Utah, United States, 84095
      • Alliance for Multispecialty Research, LLC ( Site 0051)
  • Washington
    • Spokane, Washington, United States, 99204
      • Arthritis Northwest, PLLC ( Site 0059)
    • Spokane, Washington, United States, 99204
      • Velocity Clinical Research, Spokane ( Site 0050)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concomitant group (V116 + QIV followed by placebo); Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30	Biological: QIV; Single 0.5 mL IM injection; Biological: Matching Placebo for V116; Single 0.5 mL of sterile saline IM injection; Biological: V116; Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the 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
Experimental: Sequential group (placebo + QIV followed by V116); Participants will receive a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30	Biological: QIV; Single 0.5 mL IM injection; Biological: Matching Placebo for V116; Single 0.5 mL of sterile saline IM injection; Biological: V116; Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Day 30

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Omole T, Weinberg AS, Azizad M, Greenberg D, Grijalva CG, Orenstein WA, Euler D, Fernsler D, Park J, Li J, Platt HL; STRIDE-5 study group. A phase 3 randomized, double-blind clinical study to evaluate the safety and immunogenicity of V116 when administered concomitantly with influenza vaccine in adults 50 years of age or older. Vaccine. 2025 Aug 30;62:127514. doi: 10.1016/j.vaccine.2025.127514. Epub 2025 Jul 25.

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Actual): June 21, 2023
• Study Completion (Actual): June 21, 2023

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Pneumococcal Infections; Pneumonia, Bacterial; Pneumonia, Pneumococcal
• Other Study ID Numbers: V116-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No