Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00365443

Purpose

This study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, and persistent infection caused by the HPV types in the study vaccine, (2) To demonstrate that the vaccine is well-tolerated in women, (3) To evaluate vaccine immune responses in women.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Condition	Intervention	Phase
Cervical Cancer Condylomata Acuminata	Biological: V502	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Proprietary Information - Exploratory (Non-Confirmatory) Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer Genital Warts Warts

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcome Measures:

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Study Start Date:

October 2006

Eligibility

Ages Eligible for Study:	16 Years to 26 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Female, between the ages of 16 and 26

Exclusion Criteria:

History of an abnormal PAP test or abnormal cervical biopsy result
History of external genital/vaginal warts
History of positive HPV test
Currently a user of any illegal drugs or an alcohol abuser
Are pregnant
Currently enrolled in another clinical trial
Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365443

Locations

United States, Ohio
Call for Information
Cleveland, Ohio, United States, 44122

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00365443 History of Changes
Other Study ID Numbers:	2006_503
Study First Received:	August 16, 2006
Last Updated:	March 19, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

anogenital warts
premalignancy
HPV
Human papillomavirus

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Condylomata Acuminata
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on February 12, 2012