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

Merck Sharp & Dohme (MSD)

Status and phase

Active, not recruiting

Phase 3

Conditions

Neoplasms, Anal

Warts, Genital

Treatments

Biological: V503

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04635423

jRCT2031200217 (Registry Identifier)

V503-064 (Other Identifier)

2020-001047-67 (EudraCT Number)

Details and patient eligibility

About

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 human papillomavirus (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.

The study includes a Base Study to assess efficacy and safety of V503, and an Extension Study. Participants who received placebo in the Base Study will be eligible to receive V503 vaccine on Day 1, Month 2, and Month 6 of the Extension Study. Participants who received less than 3 doses of V503 in the Base Study will be offered the opportunity to complete the 3-dose regimen in the Extension Study.

Enrollment

1,059 patients

Sex

Male

Ages

16 to 26 years old

Volunteers

Accepts Healthy Volunteers

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