A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)

Completed · Phase 3

Conditions studied: Pneumococcal Disease

In brief

This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age. The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.

Key facts

Study ID

NCT05464420

Run by

Merck Sharp & Dohme LLC

People needed

2162

Starts

2022-08-12

Expected to finish

2023-05-25

Last updated by the study team

2024-09-24

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Has underlying chronic conditions but assessed to be stable as per investigator
• Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator

You may not qualify if…

• Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 1 (Day 1)
• Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
• Has a coagulation disorder contraindicating intramuscular vaccination
• Has a recent illness with fever
• 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
• Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥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
• Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of study vaccine
• Has received any live vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live vaccine ≤30 days after receipt of study vaccine
• Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine

Where it is running

• Fiel Family and Sports Medicine, PC/CCT Research ( Site 0008) — Tempe, Arizona, United States
• Baptist Health Center For Clinical Research ( Site 0015) — Little Rock, Arkansas, United States
• Valley Clinical Trials, Inc. ( Site 0023) — Northridge, California, United States
• Artemis Institute for Clinical Research ( Site 0027) — San Diego, California, United States
• Millennium Clinical Trials ( Site 0004) — Simi Valley, California, United States
• Diablo Clinical Research, Inc. ( Site 0022) — Walnut Creek, California, United States
• Lynn Institute of Denver ( Site 0003) — Aurora, Colorado, United States
• Indago Research & Health Center, Inc ( Site 0011) — Hialeah, Florida, United States
• L&C Professional Medical Research Institute ( Site 0012) — Miami, Florida, United States
• Headlands Research Orlando ( Site 0017) — Orlando, Florida, United States
• Clinical Research Trials of Florida ( Site 0001) — Tampa, Florida, United States
• Clinical Research Prime Rexburg ( Site 0040) — Rexburg, Idaho, United States
• Healthcare Research Network - Chicago ( Site 0006) — Flossmoor, Illinois, United States
• Kentucky Pediatric/ Adult Research ( Site 0036) — Bardstown, Kentucky, United States
• Alliance for Multispecialty Research, LLC ( Site 0031) — Kansas City, Missouri, United States
• Methodist Physicians Clinic/CCT Research ( Site 0029) — Fremont, Nebraska, United States
• Healor Primary Care / CCT Research ( Site 0028) — Las Vegas, Nevada, United States
• Axces Research ( Site 0034) — Santa Fe, New Mexico, United States
• Rochester Clinical Research, Inc. ( Site 0033) — Rochester, New York, United States
• M3 Wake Research Associates ( Site 0035) — Raleigh, North Carolina, United States
• Lynn Health Science Institute ( Site 0014) — Oklahoma City, Oklahoma, United States
• Velocity Clinical Research, Providence ( Site 0018) — East Greenwich, Rhode Island, United States
• Velocity Clinical Research, Greenville ( Site 0021) — Greenville, South Carolina, United States
• Clinical Research Associates Inc ( Site 0039) — Nashville, Tennessee, United States
• Desert Clinical Research/ CCT Research ( Site 0019) — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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