Back to Trials
NCT07300267PHASE1RecruitingAccepts Healthy Volunteers

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

Merck Sharp & Dohme LLC

Start Date

1/13/2026

Completion Date

5/25/2029

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.

Detailed 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 Criteria

Age Range: No minimum to No maximum

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 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

Interventions

BIOLOGICAL

V118C (Stage 1)

BIOLOGICAL

V118C (Stage 2)

BIOLOGICAL

PCV20 (Stage 1)

BIOLOGICAL

PCV20 (Stage 2)

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Pneumococcal Infection

Locations

Madera Family Medical Group ( Site 1004)

Madera, California 93637

United States

Acevedo Clinical Research Associates ( Site 1029)

Miami, Florida 33142

United States

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

Tampa, Florida 33606

United States

Cotton O'Neil Research Center ( Site 1039)

Topeka, Kansas 66604

United States

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

Louisville, Kentucky 40202

United States

The Pediatric Center ( Site 1025)

Columbia, Maryland 21045

United States

Saint Louis University Center for Vaccine Development ( Site 1031)

St Louis, Missouri 63104

United States

Child Health Care Associates ( Site 1035)

East Syracuse, New York 13057

United States

Tribe Clinical Research, LLC-Pediatrics ( Site 1008)

Greenville, South Carolina 29607

United States

Tribe Clinical Research - Spartanburg ( Site 1001)

Spartanburg, South Carolina 29301

United States

Epic Medical Research - Carrollton ( Site 1038)

Carrollton, Texas 75006

United States

Epic Medical Research- Garland ( Site 1017)

Garland, Texas 75043

United States

University of Texas Medical Branch ( Site 1020)

League City, Texas 77573

United States

Pediatric Research of Charlottesville, LLC ( Site 1012)

Charlottesville, Virginia 22902

United States