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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00090285

First Posted: August 27, 2004

Last Update Posted: May 19, 2017

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.

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

Tracking Information

First Submitted Date ^ICMJE

August 25, 2004

First Posted Date ^ICMJE

August 27, 2004

Results First Submitted Date

October 14, 2009

Results First Posted Date

November 19, 2009

Last Update Posted Date

May 19, 2017

Actual Start Date ^ICMJE

September 24, 2004

Primary Completion Date

July 31, 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 ]
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 ]
Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) [ Time Frame: Base study: through Month 36 ]

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 ]
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 ]
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 ]

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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Arms

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

Completed

Enrollment ^ICMJE

4065

Completion Date

April 3, 2017

Primary Completion Date

July 31, 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

Sex/Gender

Sexes Eligible for Study:

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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

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.

PRS Account

Merck Sharp & Dohme Corp.

Verification Date

April 2017

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

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