A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)
A Phase 1, Randomized, Double-Blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Novel Pneumococcal Vaccine in Children
Merck Sharp & Dohme LLC
210 participants
Jan 13, 2026
INTERVENTIONAL
Conditions
Summary
Researchers are looking for new vaccines to prevent pneumococcal disease, which is any infection in the lungs or other parts of the body that is caused by a type of bacteria called Streptococcus pneumoniae. V118C is a new vaccine designed to help prevent disease from Streptococcus pneumoniae bacteria. This study will look at V118C in toddlers and infants. The goal of the study is to learn how safe V118C is for children and how well they tolerate it.
Eligibility
Inclusion Criteria7
- Stage 1:
- Is previously vaccinated with 3 routine infant doses of Pneumococcal 20-valent conjugate vaccine (PCV20)
- Is 12 through 15 months of age
- Stage 2:
- \- Is approximately 2 months of age
- Both Stages:
- Was born at full term (gestational age greater than or equal to 37 weeks)
Exclusion Criteria7
- Stage 1:
- \- Has received a PCV dose at 10 months of age and older
- Stage 2:
- Has received prior administration of any pneumococcal vaccine
- Both stages:
- Has a history of invasive pneumococcal disease (IPD)
- Has a known hypersensitivity to any component of V118C or PCV20 including diphtheria toxoid
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Interventions
IM administration of V118C
IM administration of V118C
IM administration of PCV20
IM administration of PCV20
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07300267