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Efficacy Against Oral Persistent Infection, Immunogenicity and

Trial
100%75%50%25%0%Aug 22Aug 23Aug 23 • YES 68.0%
AI-only marketDatabase

Will this trial show a positive result on incidence of HPV 16/18/31/33/45/52/58-related 6-month Persistent Oral Infection?

YES68¢
NO32¢

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Primary Completion
8/27/27
Study Completion
8/31/28
Sponsor
Merck Sharp & Dohme LLC
Ticker
$MRK
Type
Phase 3
Trial Status
Active Not Recruiting
Trial Size
6,033
NCT
NCT04199689
Trial Description
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.