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

  • STATUS
    Recruiting
  • End date
    May 25, 2029
  • participants needed
    8100
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 11 October 2022
Accepts healthy volunteers

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.

Details
Condition Papillomavirus Infections
Treatment Placebo, 9vHPV Vaccine
Clinical Study IdentifierNCT05285826
SponsorMerck Sharp & Dohme LLC
Last Modified on11 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Is a Chinese male
Has no more than 5 lifetime sexual partners

Exclusion Criteria

Has a history of known prior vaccination with an HPV vaccine
Has a history of HPV-related external genital lesions, HPV-related intra-anal lesions, or HPV-related head and neck cancer
Has a history of severe allergic reaction that required medical intervention
Has received immune globulin or blood-derived products in the past 3 months or plans to receive any before Month 7 of the study
Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids
Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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