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)

NCT05526716 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: V116-005
• Study Type: interventional
• Target: 1,080
• Locations: 1 country
• Sites: 56

Brief Summary

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.

Conditions

Pneumonia, Pneumococcal

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

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

  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

  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

  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

  Day 1 (Baseline) and Day 30 (Postvaccination)

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

  Day 30

Study Arms (2)

Concomitant group (V116 + QIV followed by placebo)

EXPERIMENTAL

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: V116; Biological: QIV; Biological: Matching Placebo for V116

Sequential group (placebo + QIV followed by V116)

EXPERIMENTAL

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: V116; Biological: QIV; Biological: Matching Placebo for V116

Interventions

V116 BIOLOGICAL

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

Concomitant group (V116 + QIV followed by placebo); Sequential group (placebo + QIV followed by V116)

QIV BIOLOGICAL

Single 0.5 mL IM injection

Concomitant group (V116 + QIV followed by placebo); Sequential group (placebo + QIV followed by V116)

Matching Placebo for V116 BIOLOGICAL

Single 0.5 mL of sterile saline IM injection

Concomitant group (V116 + QIV followed by placebo); Sequential group (placebo + QIV followed by V116)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (56)

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

Phoenix, Arizona, 85020, United States

Location

Hope Clinical Research, Inc. ( Site 0070)

Canoga Park, California, 91303, United States

Location

Paradigm Clinical Research Centers, Inc ( Site 0024)

La Mesa, California, 91942, United States

Location

Catalina Research Institute, LLC ( Site 0067)

Montclair, California, 91763, United States

Location

WR- PRI, LLC ( Site 0044)

Newport Beach, California, 92620, United States

Location

Carbon Health - North Hollywood - NoHo West ( Site 0016)

North Hollywood, California, 91606, United States

Location

Valley Clinical Trials, Inc. ( Site 0002)

Northridge, California, 91325, United States

Location

Artemis Institute for Clinical Research ( Site 0023)

San Diego, California, 92103, United States

Location

WR-MCCR, LLC ( Site 0033)

San Diego, California, 92120, United States

Location

California Research Foundation ( Site 0005)

San Diego, California, 92123, United States

Location

Diablo Clinical Research, Inc. ( Site 0020)

Walnut Creek, California, 94598, United States

Location

Velocity Clinical Research, Hallandale Beach ( Site 0064)

Hallandale, Florida, 33009, United States

Location

Indago Research & Health Center, Inc ( Site 0029)

Hialeah, Florida, 33012, United States

Location

East Coast Institute for Research, LLC ( Site 0013)

Jacksonville, Florida, 32216, United States

Location

Health Awareness ( Site 0034)

Jupiter, Florida, 33458, United States

Location

Optimal Research ( Site 0008)

Melbourne, Florida, 32934, United States

Location

Suncoast Research Group-Clinical Department ( Site 0062)

Miami, Florida, 33135, United States

Location

Suncoast Research Associates ( Site 0041)

Miami, Florida, 33173, United States

Location

Alpha Science Research ( Site 0042)

Miami, Florida, 33186, United States

Location

Lakes Research ( Site 0063)

Miami Lakes, Florida, 33014, United States

Location

Triple O Research Institute, P.A ( Site 0054)

West Palm Beach, Florida, 33407, United States

Location

East Coast Institute for Research - Canton ( Site 0004)

Canton, Georgia, 30114, United States

Location

Clinical Research Atlanta ( Site 0068)

Stockbridge, Georgia, 30281, United States

Location

Synexus Clinical Research US, Inc. ( Site 0072)

Chicago, Illinois, 60602, United States

Location

Healthcare Research Network - Chicago ( Site 0014)

Flossmoor, Illinois, 60422, United States

Location

Centennial Medical Group ( Site 0035)

Elkridge, Maryland, 21075, United States

Location

Healthcare Research Network - St. Louis ( Site 0011)

St Louis, Missouri, 63042, United States

Location

Radiant Research ( Site 0073)

St Louis, Missouri, 63141, United States

Location

Alivation Research-Primary Care ( Site 0066)

Lincoln, Nebraska, 68526, United States

Location

WR-CRCN, LLC ( Site 0018)

Las Vegas, Nevada, 89106, United States

Location

Axces Research ( Site 0037)

Santa Fe, New Mexico, 87505, United States

Location

Smith Allergy and Asthma Specialists-Certified Research Associates ( Site 0019)

Cortland, New York, 13045, United States

Location

Synexus Clinical Research US, Inc - New York ( Site 0053)

New York, New York, 10017, United States

Location

Rochester Clinical Research, Inc. ( Site 0055)

Rochester, New York, 14609, United States

Location

Meridian Clinical Research, LLC ( Site 0032)

Vestal, New York, 13850, United States

Location

Carolina Institute for Clinical Research ( Site 0047)

Fayetteville, North Carolina, 28303, United States

Location

M3 Wake Research Associates ( Site 0040)

Raleigh, North Carolina, 27612, United States

Location

CTI Clinical Research Center ( Site 0071)

Cincinnati, Ohio, 45212, United States

Location

Velocity Clinical Research, Medford ( Site 0060)

Medford, Oregon, 97504, United States

Location

Hatboro Medical Associates / CCT Research ( Site 0065)

Hatboro, Pennsylvania, 19040, United States

Location

Velocity Clinical Research, Providence ( Site 0021)

East Greenwich, Rhode Island, 02818, United States

Location

Velocity Clinical Research, Anderson ( Site 0077)

Anderson, South Carolina, 29621, United States

Location

Velocity Clinical Research, Columbia ( Site 0058)

Columbia, South Carolina, 29204, United States

Location

Holston Medical Group-Clinical Research ( Site 0028)

Bristol, Tennessee, 37620, United States

Location

Holston Medical Group-Clinical Research ( Site 0009)

Kingsport, Tennessee, 37660, United States

Location

Clinical Research Associates Inc ( Site 0026)

Nashville, Tennessee, 37203, United States

Location

Optimal Research ( Site 0015)

Austin, Texas, 78705, United States

Location

Headlands Research - Brownsville ( Site 0069)

Brownsville, Texas, 78526, United States

Location

Benchmark Research ( Site 0025)

Fort Worth, Texas, 76135, United States

Location

New Horizon Medical Group ( Site 0078)

Houston, Texas, 77042, United States

Location

Innovative Medical Research of Texas ( Site 0079)

Houston, Texas, 77065, United States

Location

LinQ Research ( Site 0074)

Pearland, Texas, 77584, United States

Location

Synexus Clinical Research US, Inc. ( Site 0001)

Murray, Utah, 84123, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0051)

South Jordan, Utah, 84095, United States

Location

Arthritis Northwest, PLLC ( Site 0059)

Spokane, Washington, 99204, United States

Location

Velocity Clinical Research, Spokane ( Site 0050)

Spokane, Washington, 99204, United States

Location

Related Publications (1)

• 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.

  PMID: 40714528 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Pneumonia, Pneumococcal

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClincalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: September 23, 2022
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: October 29, 2025
• Results First Posted: September 5, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (56)