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
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.
Description
Stage 1 of the study will be conducted in toddlers enrolled at 12 through 15 months of age who previously completed a primary 3-dose infant series with a licensed pneumococcal conjugate vaccine (PCV). Stage 2 will be conducted in infants enrolled at approximately 2 months of age, who will receive the 3+1 schedule (3 infant doses followed by a toddler dose).
Eligibility
- Age range
- 0–1 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: 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 Criteria: The main exclusion criteria include but are not limited to the following: Stage 1: \- Has received a PCV dose at 10 months of age and older Stage 2: * Has received prior administration of an…
Interventions
- BiologicalV118C (Stage 1)
IM administration of V118C
- BiologicalV118C (Stage 2)
IM administration of V118C
- BiologicalPCV20 (Stage 1)
IM administration of PCV20
- BiologicalPCV20 (Stage 2)
IM administration of PCV20
Locations (14)
- Madera Family Medical Group ( Site 1004)Madera, California
- Acevedo Clinical Research Associates ( Site 1029)Miami, Florida
- University of South Florida-Department of Pediatrics ( Site 1002)Tampa, Florida
- Cotton O'Neil Research Center ( Site 1039)Topeka, Kansas
- University of Louisville, Norton Children's Research Institute ( Site 1005)Louisville, Kentucky
- The Pediatric Center ( Site 1025)Columbia, Maryland