An Investigational Study of Gardasil™ (qHPV, V501) Vaccine in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00090285

First received: August 25, 2004

Last updated: August 16, 2016

Last verified: August 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

August 25, 2004

Last Updated Date

August 16, 2016

Start Date ^ICMJE

September 2004

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of Human Papillomavirus (HPV) Related External Genital Warts, Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer [ Time Frame: Base study: through Month 36 ] [ Designated as safety issue: No ]
Subjects with HPV 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer per 100 person-years of follow-up.
Number of Participants With Severe Injection Site Adverse Experiences (AEs) [ Time Frame: Base study: through Day 5 after any vaccination ] [ Designated as safety issue: Yes ]
Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) [ Time Frame: Base study: through Month 36 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00090285 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of HPV 6/11/16/18-related Persistent Infection [ Time Frame: Base study: through Month 36 ] [ Designated as safety issue: No ]
Subjects with HPV 6/11/16/18-related persistent infection per 100 person-years of follow-up.
Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection [ Time Frame: Base study: through Month 36 ] [ Designated as safety issue: No ]
Subjects with HPV 6/11/16/18-related DNA detection per 100 person-years of follow-up.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Substudy to Evaluate the Incidence of HPV 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer in Men Having Sex With Men (MSM) [ Time Frame: Base study: through Month 36 ] [ Designated as safety issue: No ]

Participants with HPV 6/11/16/18-related AIN or anal cancer per 100 person-years of follow-up

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Investigational Study of Gardasil™ (qHPV, V501) Vaccine in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)

Official Title ^ICMJE

An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men

Brief Summary

This study is to evaluate an investigational vaccine with the following objectives: to demonstrate that the vaccine is well tolerated in young men; to demonstrate that the vaccine reduces incidence of external genital lesions (Condylomata acuminata [anogenital warts], penile/perianal/perineal intraepithelial neoplasia [PIN], penile, perianal, perineal cancer) in young men; to demonstrate that the vaccine reduces the incidence of anal intraepithelial neoplasia (AIN) or anal cancer in men having sex with men (MSM); and to demonstrate that the vaccine reduces incidence of Human Papilloma Virus (HPV) infection in young men.

Detailed Description

The base study (V501-020) encompassed Day 1 through Month 7, during which time participants received randomly assigned Gardasil™ (qHPV vaccine) or placebo at Day 1, Month 2, and Month 6. Base study follow-up continued through Month 36.

The base study was extended in protocol V501-020-10 Extension 1 (EXT1). Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.

A second extension study, V501-020-21 (EXT2), will estimate the long-term safety and effectiveness of qHPV vaccine during a period of 10 years following initial enrollment in the base study. Subjects who received at least one dose of qHPV vaccine in either the base study or EXT1 are eligible to enroll in EXT2.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Condylomata Acuminata

Intervention ^ICMJE

Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Duration of Treatment: 6 months
Other Names:
- qHPV
- V501
Biological: Comparator: placebo (unspecified)
Duration of Treatment: 6 months

Study Arm (s)

Experimental: qHPV Vaccine
Intervention: Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Placebo Comparator: Placebo
Intervention: Biological: Comparator: placebo (unspecified)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

4065

Estimated Completion Date

March 2017

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy male between the ages of 16 years and 23 years and 364 days. For the MSM substudy, between the ages of 16 years and 26 years and 364 days.
No clinical evidence of genital lesions suggesting sexually-transmitted disease, and no history of anogenital warts
Additional criteria will be discussed with you by the physician

Exclusion Criteria:

Concurrently enrolled in a clinical study involving collection of genital specimens
History of known prior vaccination with an HPV vaccine
Received an inactivated vaccine within 14 days or a live virus vaccine within 21 days prior to enrollment
History of a severe allergic reaction that required medical intervention
Received any immune globulin or blood-derived products within 6 months prior to the first study injection
History of splenectomy, immune disorders, or receiving immunosuppressives
Immunocompromised or diagnosed with HIV infection
Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
History of recent or ongoing alcohol or drug abuse

Gender

Male

Ages

16 Years to 26 Years (Child, Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Australia, Brazil, Canada, Costa Rica, Croatia, Finland, Germany, Mexico, Netherlands, Norway, Peru, Philippines, Portugal, South Africa, Spain, Sweden, Taiwan, United States

Administrative Information

NCT Number ^ICMJE

NCT00090285

Other Study ID Numbers ^ICMJE

V501-020, Formerly-0904HPVHMES, 2004_103

Has Data Monitoring Committee

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Merck Sharp & Dohme Corp.

Study Sponsor ^ICMJE

Merck Sharp & Dohme Corp.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck Sharp & Dohme Corp.

Information Provided By

Merck Sharp & Dohme Corp.

Verification Date

August 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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