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)
NCT ID: NCT05526716
Last Updated: 2025-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1080 participants
INTERVENTIONAL
2022-09-23
2023-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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
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
QIV
Single 0.5 mL IM injection
Matching Placebo for V116
Single 0.5 mL of sterile saline IM injection
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
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
QIV
Single 0.5 mL IM injection
Matching Placebo for V116
Single 0.5 mL of sterile saline IM injection
Interventions
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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
QIV
Single 0.5 mL IM injection
Matching Placebo for V116
Single 0.5 mL of sterile saline IM injection
Eligibility Criteria
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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
* 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
50 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Carbon Health - North Hollywood - NoHo West ( Site 0016)
North Hollywood, California, United States
Valley Clinical Trials, Inc. ( Site 0002)
Northridge, California, United States
Artemis Institute for Clinical Research ( Site 0023)
San Diego, California, United States
WR-MCCR, LLC ( Site 0033)
San Diego, California, United States
California Research Foundation ( Site 0005)
San Diego, California, United States
Diablo Clinical Research, Inc. ( Site 0020)
Walnut Creek, California, United States
Velocity Clinical Research, Hallandale Beach ( Site 0064)
Hallandale, Florida, United States
Indago Research & Health Center, Inc ( Site 0029)
Hialeah, Florida, United States
East Coast Institute for Research, LLC ( Site 0013)
Jacksonville, Florida, United States
Health Awareness ( Site 0034)
Jupiter, Florida, United States
Optimal Research ( Site 0008)
Melbourne, Florida, United States
Suncoast Research Group-Clinical Department ( Site 0062)
Miami, Florida, United States
Suncoast Research Associates ( Site 0041)
Miami, Florida, United States
Alpha Science Research ( Site 0042)
Miami, Florida, United States
Lakes Research ( Site 0063)
Miami Lakes, Florida, United States
Triple O Research Institute, P.A ( Site 0054)
West Palm Beach, Florida, United States
East Coast Institute for Research - Canton ( Site 0004)
Canton, Georgia, United States
Clinical Research Atlanta ( Site 0068)
Stockbridge, Georgia, United States
Synexus Clinical Research US, Inc. ( Site 0072)
Chicago, Illinois, United States
Healthcare Research Network - Chicago ( Site 0014)
Flossmoor, Illinois, United States
Centennial Medical Group ( Site 0035)
Elkridge, Maryland, United States
Healthcare Research Network - St. Louis ( Site 0011)
St Louis, Missouri, United States
Radiant Research ( Site 0073)
St Louis, Missouri, United States
Alivation Research-Primary Care ( Site 0066)
Lincoln, Nebraska, United States
WR-CRCN, LLC ( Site 0018)
Las Vegas, Nevada, United States
Axces Research ( Site 0037)
Santa Fe, New Mexico, United States
Smith Allergy and Asthma Specialists-Certified Research Associates ( Site 0019)
Cortland, New York, United States
Synexus Clinical Research US, Inc - New York ( Site 0053)
New York, New York, United States
Rochester Clinical Research, Inc. ( Site 0055)
Rochester, New York, United States
Meridian Clinical Research, LLC ( Site 0032)
Vestal, New York, United States
Carolina Institute for Clinical Research ( Site 0047)
Fayetteville, North Carolina, United States
M3 Wake Research Associates ( Site 0040)
Raleigh, North Carolina, United States
CTI Clinical Research Center ( Site 0071)
Cincinnati, Ohio, United States
Velocity Clinical Research, Medford ( Site 0060)
Medford, Oregon, United States
Hatboro Medical Associates / CCT Research ( Site 0065)
Hatboro, Pennsylvania, United States
Velocity Clinical Research, Providence ( Site 0021)
East Greenwich, Rhode Island, United States
Velocity Clinical Research, Anderson ( Site 0077)
Anderson, South Carolina, United States
Velocity Clinical Research, Columbia ( Site 0058)
Columbia, South Carolina, United States
Holston Medical Group-Clinical Research ( Site 0028)
Bristol, Tennessee, United States
Holston Medical Group-Clinical Research ( Site 0009)
Kingsport, Tennessee, United States
Clinical Research Associates Inc ( Site 0026)
Nashville, Tennessee, United States
Optimal Research ( Site 0015)
Austin, Texas, United States
Headlands Research - Brownsville ( Site 0069)
Brownsville, Texas, United States
Benchmark Research ( Site 0025)
Fort Worth, Texas, United States
New Horizon Medical Group ( Site 0078)
Houston, Texas, United States
Innovative Medical Research of Texas ( Site 0079)
Houston, Texas, United States
LinQ Research ( Site 0074)
Pearland, Texas, United States
Synexus Clinical Research US, Inc. ( Site 0001)
Murray, Utah, United States
Alliance for Multispecialty Research, LLC ( Site 0051)
South Jordan, Utah, United States
Arthritis Northwest, PLLC ( Site 0059)
Spokane, Washington, United States
Velocity Clinical Research, Spokane ( Site 0050)
Spokane, Washington, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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V116-005
Identifier Type: -
Identifier Source: org_study_id
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