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) and hemagglutination inhibition (HAI) geometric mean titers (GMTs) at 30 days postvaccination.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Pneumococcal
• Intervention / Treatment: Biological: V116; Biological: QIV; Biological: Matching Placebo for 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 Beach, 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
    • Saint Louis, Missouri, United States, 63042
      • Healthcare Research Network - St. Louis ( Site 0011)
    • Saint 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:

• 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:

• Has a history of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years
• Has a known hypersensitivity to any component of V116 or any influenza vaccine, including diphtheria toxoid
• Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
• Has a coagulation disorder contraindicating intramuscular vaccination
• 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
• Received any pneumococcal vaccine <12 months prior to enrollment (including pneumococcal 13-valent conjugate vaccine [PCV13] followed by pneumococcal 23-valent polysaccharide vaccine [PPSV23] and PPSV23 followed by PCV13)
• Had prior administration of PCV15 or PCV20
• Received any influenza vaccine <6 months prior to enrollment or is expected to receive any influenza vaccine during the study outside of the protocol
• Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥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
• Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine
• Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine
• Received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product before the Day 30 postvaccination blood draw is complete
• Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study

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: 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, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution; Biological: QIV; Single 0.5 mL IM injection; Biological: Matching Placebo for V116; Single 0.5 mL of sterile saline IM injection
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: 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, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution; Biological: QIV; Single 0.5 mL IM injection; Biological: Matching Placebo for V116; Single 0.5 mL of sterile saline IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage 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. The solicited injection-site AEs include tenderness/injection-site pain, injection-site redness/injection-site erythema, and injection-site swelling/injection-site swelling.	Up to 5 days post-vaccination
Percentage 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. The solicited systemic AEs include muscle aches all over body/myalgia, headache, and tiredness/fatigue.	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 will be summarized.	Up to ~210 days
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses	Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA).	30 days after V116 vaccination (Day 30 for concomitant group and Day 60 for sequential group)
GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI)	Activity for the 4 strains contained in QIV vaccine will be 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 GMC of serotype-specific IgG for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using an pneumococcal electrochemiluminescence (Pn ECL) assay.	30 days after V116 vaccination (Day 30 for concomitant group and Day 60 for sequential group)
Geometric Mean Fold Rise (GMFR) of Serotype-specific OPA	Activity for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.	Day 1 (Baseline) and Day 30 post-vaccination for concomitant group. Day 1 (Baseline) and Day 60 post-vaccination for sequential group.
Geometric Mean Fold Rise (GMFR) of Serotype-specific IgG	Activity for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using an Pn ECL assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.	Day 1 (Baseline) and Day 30 post-vaccination for concomitant group. Day 1 (Baseline) and Day 60 post-vaccination for sequential group.
GMFR in Influenza Strain-specific HAI	Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. GMFR is GMT 30 days after vaccination / GMT at Baseline.	Day 1 (Baseline) and Day 30
Percentage of Participants with Influenza Strain-specific HAI Titer ≥1:40	Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay.	Day 30
Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI	Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay.	Day 30

Collaborators and Investigators

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

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 (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; 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