Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)

Completed · Phase 3

Conditions studied: Pneumococcal Infection

In brief

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine (\[Prevnar 20™ / APEXXNAR™\]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.

Key facts

Study ID

NCT05425732

Run by

Merck Sharp & Dohme LLC

People needed

2663

Starts

2022-07-13

Expected to finish

2023-05-18

Last updated by the study team

2024-10-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of an early undetected pregnancy.

You may not qualify if…

• 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 of Visit 1 (Day 1)
• Has a known hypersensitivity to any component of V116 or PCV20, 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 IM vaccination
• Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring <72 hours before receipt of study vaccine
• Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
• Received prior administration (prior to age of 5 is acceptable) of any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside 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 (inactivated influenza and SARS-CoV2 vaccines may be acceptable)
• 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 until the Day 30 postvaccination blood draw is complete

Where it is running

• Lenzmeier Family Medicine/CCT Research ( Site 0006) — Glendale, Arizona, United States
• Desert Clinical Research/ CCT Research ( Site 0040) — Mesa, Arizona, United States
• Foothills Research Center/ CCT Research ( Site 0021) — Phoenix, Arizona, United States
• Fiel Family and Sports Medicine, PC/CCT Research ( Site 0003) — Tempe, Arizona, United States
• Baptist Health Center For Clinical Research ( Site 0019) — Little Rock, Arkansas, United States
• Southland Clinical Research Center-Research ( Site 0054) — Fountain Valley, California, United States
• Sunwise Clinical Research ( Site 0024) — Lafayette, California, United States
• Chemidox Clinical Trials ( Site 0048) — Lancaster, California, United States
• Paradigm Clinical Research Centers, Inc ( Site 0018) — Redding, California, United States
• Peninsula Research Associates ( Site 0079) — Rolling Hills Estates, California, United States
• Acclaim Clinical Research ( Site 0083) — San Diego, California, United States
• Millennium Clinical Trials ( Site 0013) — Simi Valley, California, United States
• Lynn Institute of Denver ( Site 0012) — Aurora, Colorado, United States
• Paradigm Clinical Research Centers, Inc ( Site 0027) — Wheat Ridge, Colorado, United States
• JEM Research Institute ( Site 0072) — Atlantis, Florida, United States
• Alliance for Multispecialty Research, LLC ( Site 0015) — Coral Gables, Florida, United States
• Hillcrest Medical Research ( Site 0049) — DeLand, Florida, United States
• East Coast Institute for Research, LLC ( Site 0070) — Jacksonville, Florida, United States
• East Coast Institute for Research ( Site 0071) — Lake City, Florida, United States
• L&C Professional Medical Research Institute ( Site 0025) — Miami, Florida, United States
• Advanced Medical Research Institute ( Site 0014) — Miami, Florida, United States
• Headlands Research Orlando ( Site 0031) — Orlando, Florida, United States
• Genesis Clinical Research, LLC ( Site 0016) — Tampa, Florida, United States
• Clinical Research Trials of Florida ( Site 0007) — Tampa, Florida, United States
• Central Research Associates ( Site 0067) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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