Status:
COMPLETED
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Pneumococcal Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 (\[P...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2023
Estimated Enrollment :
2663 Patients enrolled
Trial Details
Trial ID
NCT05425732
Start Date
July 13 2022
End Date
May 18 2023
Last Update
October 26 2024
Active Locations (112)
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1
Central Research Associates ( Site 0067)
Birmingham, Alabama, United States, 35205
2
Lenzmeier Family Medicine/CCT Research ( Site 0006)
Glendale, Arizona, United States, 85308
3
Desert Clinical Research/ CCT Research ( Site 0040)
Mesa, Arizona, United States, 85213
4
Foothills Research Center/ CCT Research ( Site 0021)
Phoenix, Arizona, United States, 85044