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RECRUITING
NCT07300267
PHASE1

A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: A Phase 1, Randomized, Double-Blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Novel Pneumococcal Vaccine in Children

Key Details

Gender

All

Age Range

2 Months - 15 Months

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2026-01-13

Completion Date

2029-05-25

Last Updated

2026-04-02

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

V118C (Stage 1)

IM administration of V118C

BIOLOGICAL

V118C (Stage 2)

IM administration of V118C

BIOLOGICAL

PCV20 (Stage 1)

IM administration of PCV20

BIOLOGICAL

PCV20 (Stage 2)

IM administration of PCV20

Locations (13)

Madera Family Medical Group ( Site 1004)

Madera, California, United States

Acevedo Clinical Research Associates ( Site 1029)

Miami, Florida, United States

University of South Florida-Department of Pediatrics ( Site 1002)

Tampa, Florida, United States

Cotton O'Neil Research Center ( Site 1039)

Topeka, Kansas, United States

University of Louisville, Norton Children's Research Institute ( Site 1005)

Louisville, Kentucky, United States

Saint Louis University Center for Vaccine Development ( Site 1031)

St Louis, Missouri, United States

Child Health Care Associates ( Site 1035)

East Syracuse, New York, United States

Tribe Clinical Research, LLC-Pediatrics ( Site 1008)

Greenville, South Carolina, United States

Tribe Clinical Research - Spartanburg ( Site 1001)

Spartanburg, South Carolina, United States

Epic Medical Research - Carrollton ( Site 1038)

Carrollton, Texas, United States

Epic Medical Research- Garland ( Site 1017)

Garland, Texas, United States

University of Texas Medical Branch ( Site 1020)

League City, Texas, United States

Pediatric Research of Charlottesville, LLC ( Site 1012)

Charlottesville, Virginia, United States