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

This study is currently recruiting participants.
Verified April 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01862874
First received: May 22, 2013
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

A study to evaluate the efficacy, immunogenicity, 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.


Condition Intervention Phase
Anogenital Human Papilloma Virus Infection
Condyloma Acuminata
Biological: V501
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Combined Incidence of HPV 6-, 11-, 16-, or 18-Related Persistent Infection [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • Percentage of Participants with an Adverse Event (AE) [ Time Frame: Up to 14 days after any vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with Vaccine-Related Serious Adverse Events (SAEs) [ Time Frame: Up to 36 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: June 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V501
V501: 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Biological: V501
Other Names:
  • GARDASIL™
  • Quadrivalent HPV (Type 6, 11, 16 and 18) L1 Virus-Like Particle vaccine
Placebo Comparator: Placebo
Placebo to match V501: 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Biological: Placebo

  Eligibility

Ages Eligible for Study:   16 Years to 26 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01862874

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Japan
MSD K.K. Recruiting
Chiyoda-Ku, Tokyo, Japan, 102-8667
Contact: Japan Call Center    81-3-6272-1957      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01862874     History of Changes
Other Study ID Numbers: V501-122, 132237
Study First Received: May 22, 2013
Last Updated: April 4, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Condylomata Acuminata
Papilloma
Virus Diseases
Warts
Papillomavirus Infections
DNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014