Study to Test the Safety of HPV Vaccine in Women - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00517309

Purpose

The primary purpose of the study is to test the safety of HPV Vaccine in Women

Condition	Intervention	Phase
Cervical Cancer Genital Warts	Biological: V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years Biological: Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years	Phase III

MedlinePlus related topics: Genital Warts Hepatitis Hepatitis B Warts

Drug Information available for: Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Immunogenicity and Safety of Quadrivalent HPV L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women When Administered Alone or Concomitantly With Hepatitis B Vaccine (Recombinant)--the F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease

Further study details as provided by Merck:

Primary Outcome Measures:

Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.

Secondary Outcome Measures:

HPV vaccine is well tolerated in 16-23 year old females.

Estimated Enrollment:	1800
Study Start Date:	March 2003
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	16 Years to 23 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Females age 16 to 23 years old
Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit

Exclusion Criteria:

History of vaccination with an HPV vaccine
History of hepatitis B infection
History of vaccination with hepatitis B vaccine
History of genital warts or treatment for genital warts

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517309

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Wheeler CM, Bautista OM, Tomassini JE, Nelson M, Sattler CA, Barr E; on Behalf of the Protocol 11 study Investigators. Safety and immunogenicity of co-administered quadrivalent human papillomavirus (HPV)-6/11/16/18 L1 virus-like particle (VLP) and hepatitis B (HBV) vaccines. Vaccine. 2008 Jan 30;26(5):686-696. Epub 2007 Dec 5.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_576, V501-011
Study First Received:	August 15, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00517309
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Liver Diseases
Skin Diseases
Condyloma
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Skin Diseases, Infectious

Digestive System Diseases
Warts
Condyloma acuminatum
Condylomata Acuminata
Sexually Transmitted Diseases
Hepatitis B
Papillomavirus Infections
DNA Virus Infections

Additional relevant MeSH terms:

Skin Diseases, Viral
Tumor Virus Infections
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009