Status:
COMPLETED
A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Pneumococcal Infection
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as,...
Eligibility Criteria
Inclusion
- Has a diagnosis and stable medical management (for at least 3 months) of one of the following risk conditions for pneumococcal disease: Diabetes mellitus, chronic compensated liver disease, chronic lung disease, chronic heart disease, or chronic kidney disease.
- Has completed pneumococcal conjugate vaccine regimen (PCV7, PCV10, or PCV13) at least 8 weeks before study enrollment.
Exclusion
- Has previously received PPSV23 vaccine
- Has a history of active hepatitis within 3 months before study vaccination
- History of invasive pneumococcal disease within 3 years before study vaccination
Key Trial Info
Start Date :
January 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2025
Estimated Enrollment :
882 Patients enrolled
Trial Details
Trial ID
NCT06177912
Start Date
January 18 2024
End Date
February 26 2025
Last Update
March 24 2025
Active Locations (92)
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1
Central Research Associates ( Site 0145)
Birmingham, Alabama, United States, 35205
2
Velocity Clinical Research, Phoenix ( Site 0122)
Phoenix, Arizona, United States, 85006
3
Madera Family Medical Group ( Site 0120)
Madera, California, United States, 93637
4
Optumcare Colorado Springs, LLC ( Site 0113)
Colorado Springs, Colorado, United States, 80922