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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01862874
Recruitment Status : Completed
First Posted : May 27, 2013
Last Update Posted : October 6, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Anogenital Human Papilloma Virus Infection Condyloma Acuminata Biological: V501 Biological: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Actual Study Start Date : June 27, 2013
Actual Primary Completion Date : August 30, 2017
Actual Study Completion Date : August 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Warts

Arm Intervention/treatment
Experimental: V501
V501: 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Biological: V501
Other Names:
  • 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

Primary Outcome Measures :
  1. Combined Incidence of HPV 6-, 11-, 16-, or 18-Related Persistent Infection [ Time Frame: Up to 36 months ]
  2. Percentage of Participants with an Adverse Event (AE) [ Time Frame: Up to 14 days after any vaccination ]
  3. Percentage of Participants with Vaccine-Related Serious Adverse Events (SAEs) [ Time Frame: Up to 36 Months ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   16 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01862874     History of Changes
Other Study ID Numbers: V501-122
132237 ( Registry Identifier: JAPIC-CTI )
First Posted: May 27, 2013    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Virus Diseases
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Tumor Virus Infections