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

Merck Sharp & Dohme (MSD)

Status and phase

Active, not recruiting

Phase 3

Conditions

Papillomavirus Infections

Treatments

Other: Placebo

Biological: 9vHPV Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05285826

V503-052

Details and patient eligibility

About

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.

Enrollment

8,100 estimated patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.