Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)

NCT ID: NCT01862874

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-27
• Study Completion Date: 2017-08-30

Brief Summary

A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.

Conditions

Anogenital Human Papilloma Virus Infection; Condyloma Acuminata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

V501

Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.

Group Type: EXPERIMENTAL

V501

Intervention Type: BIOLOGICAL

Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant

Placebo

Participants received placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Formulated with AAHS adjuvant

Interventions

V501

Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant

Intervention Type: BIOLOGICAL

Placebo

Formulated with AAHS adjuvant

Intervention Type: BIOLOGICAL

Other Intervention Names

GARDASIL™; Quadrivalent HPV (Type 6, 11, 16 and 18) L1 Virus-Like Particle vaccine

Eligibility Criteria

Inclusion Criteria

• Japanese
• No clinical evidence of gross genital lesion suggesting sexually-transmitted disease and no clinically present external genital warts

Exclusion Criteria

• History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
• History of external genital warts
• History of severe allergic reaction that required medical intervention
• Received immune globulin or blood-derived products in the past 6 months or plan to receive any before Month 7 of the study
• 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
• Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids
• Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
• Ongoing alcohol or drug abuse within the past 12 months

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Mikamo H, Yamagishi Y, Murata S, Yokokawa R, Han SR, Wakana A, Sawata M, Tanaka Y. Efficacy, safety, and immunogenicity of a quadrivalent HPV vaccine in Japanese men: A randomized, Phase 3, placebo-controlled study. Vaccine. 2019 Mar 14;37(12):1651-1658. doi: 10.1016/j.vaccine.2019.01.069. Epub 2019 Feb 20.

Reference Type: RESULT

PMID: 30797638 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

132237

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-002931-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V501-122

Identifier Type: OTHER

Identifier Source: secondary_id

V501-122

Identifier Type: -

Identifier Source: org_study_id