Clinical trial NCT01862874: Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)
Official title: A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anogenital Human Papilloma Virus Infection
Condyloma Acuminata
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-05-27
Enrollment: 1124
Sex: MALE
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Japanese
* No clinical evidence of gross genital lesion suggesting sexually-transmitted disease and no clinically present external genital warts
* Other inclusion criteria will be discussed with the investigator during screening

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

Primary outcomes:
measure: Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection
timeFrame: Up to Month 36
measure: Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card
timeFrame: Up to 5 days after any vaccination
measure: Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card
timeFrame: Up to 5 days after any vaccination
measure: Percentage of Participants With a Systemic Adverse Event
timeFrame: Up to 15 days after any vaccination
measure: Percentage of Participants With a Vaccine-related Systemic Adverse Event
timeFrame: Up to 15 days after any vaccination
Secondary outcomes:
measure: Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection or Disease
timeFrame: Up to Month 36
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.