NCT07300267

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 2 Months – 15 Months
• Healthy volunteers: Accepted

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).

Conditions

• Pneumococcal Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-13
• Primary completion: 2028-10-24
• Completion: 2029-05-25
• First posted: 2025-12-23
• Last updated: 2026-04-17

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study