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)
Completed · Phase 3 · Has a placebo group
Conditions studied: Pneumonia, Pneumococcal
In brief
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.
Key facts
- Study ID
- NCT05526716
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 1080
- Starts
- 2022-09-23
- Expected to finish
- 2023-06-21
- Last updated by the study team
- 2025-10-29
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- 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
- Central Phoenix Medical Clinic-Synexus Clinical Research US ( Site 0012) — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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