NCT05285826

Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)

Name: Clinical Trial NCT05285826
Creator: Merck Sharp & Dohme LLC
Keywords: Papillomavirus Infections, 9vHPV Vaccine, Phase 3, biological, clinical trial, China

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy, Immunogenicity, and Safety of V503, a 9-Valent Human Papillomavirus (HPV) Vaccine, in Chinese Males 20 to 45 Years of Age

Merck Sharp & Dohme LLC·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 LLC
Location: Bejing,Chongqing,Chongqing,Lanzhou,Guangzhou,Shenzhen,Liuzhou,Liuzhou,Wuhan,Changsha,Changsha,Louxing District,XiangTan,Xiangxiang,Yongzhou,Nanjing,Shenyang,Shenyang,Yuncheng,Yuncheng,Yuncheng,Yunchen, China

Timeline & enrollment

Phase: Phase 3
Start date: Feb 18, 2022
End date: May 25, 2029
Enrollment: 8100 participants

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

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: NCT05285826
Type: Non-Device Trial

About this record

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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