NCT04199689

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

Name: Clinical Trial NCT04199689
Creator: Merck Sharp & Dohme Corp.
Keywords: Papillomavirus Infections, 9vHPV Vaccine, Phase 3, biological, clinical trial, Belgium,Brazil,Colombia,Czech,France,Germany,Israel,Italy,Japan,South Korea,Mexico,Peru,Spain,Taiwan

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

Merck Sharp & Dohme Corp.·Phase 3·ClinicalTrials.gov·biologicalNot yet recruiting

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Study focus

Disease/Condition: Papillomavirus Infections
Drug/Device/Intervention: 9vHPV Vaccine
Study type: Interventional
Intervention type: biological

Sponsor & location

Primary sponsor: Merck Sharp & Dohme Corp.
Location: 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: Phase 3
Start date: Feb 27, 2020
End date: Aug 20, 2024
Enrollment: 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 chaptersPapovavirus infection, unspecified sitePapilloedema, unspecifiedViral infection, unspecifiedParvovirus as the cause of diseases classified to other chapters

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT04199689
Type: Non-Device Trial

About this record

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.