Efficacy Immunogenicity and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)

  • End date
    Jan 30, 2025
  • participants needed
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 19 July 2021


The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 (9-valent human papillomavirus [9vHPV] vaccine) in preventing HPV-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo.

Condition Condyloma acuminatum, Anal Cancer, Genital Warts
Treatment Placebo, V503
Clinical Study IdentifierNCT04635423
SponsorMerck Sharp & Dohme Corp.
Last Modified on19 July 2021


Yes No Not Sure

Inclusion Criteria

Is a Japanese male 16 to 26 years of age
Has no more than 5 lifetime sexual partners

Exclusion Criteria

Has a history of known prior vaccination with an HPV vaccine or plans to receive one outside the study
Has a history of external genital warts
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 plan 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 intramuscular injections
Has ongoing alcohol or drug abuse within the past 12 months
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