NCT07224477

A Clinical Study of V540A in Healthy Female Participants (V540A-005)

A Phase 2, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540A in Healthy Females 16 to 26 Years of Age

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 525 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 16 Years – 26 Years
• Healthy volunteers: Accepted

Summary

Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. A standard vaccine to prevent HPV-related cancers is V503. V503 protects against 9 types of HPV. V540A is a study vaccine designed to protect against the same (shared) 9 HPV types plus other (unique) HPV types. Researchers want to learn if V540A: * Is safe and if people tolerate it * Works as well as V503 to cause an immune response (the body's response to protect against infections and illnesses) to the shared HPV types.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	V540A-2	Suspension administered via intramuscular (IM) injection.
BIOLOGICAL	V540A-3	Suspension administered via intramuscular (IM) injection.
BIOLOGICAL	GARDASIL®9	Suspension administered via IM injection.

Timeline

• Start date: 2026-07-20
• Primary completion: 2028-04-04
• Completion: 2028-04-04
• First posted: 2025-11-04
• Last updated: 2026-02-19

Regulatory

• FDA-regulated drug study