Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052) - Trial NCT05285826
Access comprehensive clinical trial information for NCT05285826 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme LLC and is currently Not yet recruiting. The study focuses on Papillomavirus Infections. Target enrollment is 8100 participants.
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Study Focus
Sponsor & Location
Merck Sharp & Dohme LLC
Timeline & Enrollment
Phase 3
Feb 18, 2022
May 25, 2029
Primary Outcome
Stage I: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related External Genital and Intra-anal 12-month Persistent Infection,Stages I and II: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related Genital Warts, PIN, or Penile/Perianal/Perineal Cancer
Summary
This study will evaluate the efficacy, immunogenicity, and safety of 9-valent human
 papillomavirus (9vHPV; V503) vaccine in Chinese men 20 to 45 years of age. It will enroll
 heterosexual men (HM) and men who have sex with men (MSM), will be stratified by age and
 sexual orientation, and will have two stages. The primary hypothesis of Stage I is: 9vHPV
 vaccine reduces the combined incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and
 58-related external genital and intra-anal 12-month persistent infection (PI) compared with
 placebo in males 20 to 45 years of age who are seronegative at Day 1 and polymerase chain
 reaction (PCR) negative from Day 1 through one month post-Dose 3 to the relevant HPV type.
 The primary hypothesis of Stages I and II combined is: 9vHPV vaccine reduces the combined
 incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related genital warts,
 penile/perianal/perineal intraepithelial neoplasia (PIN), or penile/perianal/perineal cancer
 compared with placebo in males 20 to 45 years of age who are seronegative at Day 1 and PCR
 negative from Day 1 through one month post-Dose 3 to the relevant HPV type.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05285826
Non-Device Trial