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Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)

NCT04199689 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6033

Last updated 2025-03-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9vHPV vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of human papillomavirus (HPV) 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo.

There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.

Conditions

  • Papillomavirus Infections

Interventions

BIOLOGICAL

9vHPV Vaccine

9vHPV is an aluminum-adjuvanted recombinant protein vaccine prepared from the highly purified virus-like particles of the recombinant major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 given as a 0.5 mL intramuscular injection.

OTHER

Placebo (Saline for Injection)

0.9% sodium chloride given as a 0.5-mL intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-27
Primary Completion
2027-08-27
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Colombia
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Mexico
  • Peru
  • South Korea
  • Spain
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04199689 on ClinicalTrials.gov