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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) - Trial NCT04199689

Access comprehensive clinical trial information for NCT04199689 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme Corp. and is currently Not yet recruiting. The study focuses on Papillomavirus Infections. Target enrollment is 6000 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT04199689
Phase 3
Not yet recruiting
biological
Trial Details
ClinicalTrials.gov • NCT04199689
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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)
A Phase 3, International, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the Prevention of Oral Persistent Infection With HPV Types 16, 18, 31, 33, 45, 52, or 58 in Adult Males, 20 to 45 Years of Age

Study Focus

Papillomavirus Infections

9vHPV Vaccine

Interventional

biological

Sponsor & Location

Merck Sharp & Dohme Corp.

Northridge,Rialto,Simi Valley,Spring Valley,Walnut Creek,Coral Gables,Miami,Tampa,Augusta,Meridian,Topeka,Wichita,Bardstown,Hazelwood,Las Vegas,Cortland,New York,New York,Rochester,Salisbury,Cleveland, Belgium,Brazil,Colombia,Czech,France,Germany,Israel,Italy,Japan,South Korea,Mexico,Peru,Spain,Taiwan

Timeline & Enrollment

Phase 3

Feb 27, 2020

Aug 20, 2024

6000 participants

Primary Outcome

Incidence of Human Papillomavirus (HPV)16/18/31/33/45/52/58-related 6-month Persistent Oral Infection

Summary

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

ICD-10 Classifications

Papillomavirus as the cause of diseases classified to other chapters
Papovavirus infection, unspecified site
Papilloedema, unspecified
Viral infection, unspecified
Parvovirus as the cause of diseases classified to other chapters

Data Source

ClinicalTrials.gov

NCT04199689

Non-Device Trial