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

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

MedlinePlus related topics:

Cancer Cervical Cancer Genital Warts

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Proprietary Information - Exploratory (Non-Confirmatory) Trial

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

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

Keywords provided by Merck:

anogenital warts

premalignancy

HPV

Human papillomavirus

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral

Skin Diseases

Condyloma

Genital Neoplasms, Female

Uterine Diseases

Urogenital Neoplasms

Uterine Cervical Neoplasms

Genital Diseases, Female

Virus Diseases

Skin Diseases, Infectious

Uterine Cervical Diseases

Warts

Condyloma acuminatum

Condylomata Acuminata

Sexually Transmitted Diseases

Uterine Neoplasms

Papillomavirus Infections

DNA Virus Infections

Additional relevant MeSH terms:

Skin Diseases, Viral

Neoplasms

Neoplasms by Site

Tumor Virus Infections

ClinicalTrials.gov processed this record on September 05, 2008

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