NCT07168915

A Study of V118E in Healthy Participants (V118E-003)

A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V118 Formulation E in Healthy Adults

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

Researchers are looking for new vaccines to prevent illnesses caused by a type of bacteria called Streptococcus pneumoniae. There are many different types of Streptococcus pneumoniae bacteria, called serotypes. Vaccines contain small parts of certain serotypes. These parts will not cause an infection but help the body create antibodies (proteins) to fight the bacteria. PREVNAR 20™ is a vaccine given to help to prevent disease from Streptococcus pneumoniae bacteria. Researchers designed a new vaccine, V118E, to help prevent disease from Streptococcus pneumoniae bacteria. The goal of this study is to learn how safe V118 formulation E is in Healthy Adults and how well people tolerate it.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	V118E	IM administration
BIOLOGICAL	PREVNAR 20™	IM administration
BIOLOGICAL	Saline	IM administration

Timeline

• Start date: 2025-10-08
• Primary completion: 2027-11-12
• Completion: 2027-11-12
• First posted: 2025-09-11
• Last updated: 2026-02-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study