Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00543543

Purpose

The purpose of this study is to evaluate the safety and effectiveness of V503 in comparison to GARDASIL.

Condition	Intervention	Phase
Cervical Cancer Vulvar Cancer Vaginal Cancer Genital Warts Human Papillomavirus Infection	Biological: Comparator: GARDASIL(R) Biological: Comparator: V503	Phase III

MedlinePlus related topics: Cancer Genital Warts Vaginal Cancer Vulvar Cancer Warts

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL, Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26- Year-Old Women

Further study details as provided by Merck:

Primary Outcome Measures:

Tolerability and prevention of cervical, vulvar, vaginal disease caused by the HPV types in the vaccine [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immunogenicity against HPV types contained in vaccine [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	14620
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Part A: Arm 1: Active Comparator GARDASIL(R) 0.5 mL injection in 3 dose regimen	Biological: Comparator: GARDASIL(R) GARDASIL(R) 0.5 mL injection in 3 dose regimen
Part A: Arm 2: Experimental V503 0.5 mL injection in 3 dose regimen	Biological: Comparator: V503 V503 0.5 mL injection in 3 dose regimen
Part A: Arm 3: Experimental V503 0.5 mL injection in 3 dose regimen	Biological: Comparator: V503 V503 0.5 mL injection in 3 dose regimen
Part A: Arm 4: Experimental V503 0.5 mL injection in 3 dose regimen	Biological: Comparator: V503 V503 0.5 mL injection in 3 dose regimen
Part B: Arm 1: Experimental V503 (dose to be selected after Part A is complete) in 3 dose regimen	Biological: Comparator: V503 V503 0.5 mL injection in 3 dose regimen
Part B: Arm 2: Active Comparator GARDASIL(R) 0.5 mL injection in 3 dose regimen	Biological: Comparator: GARDASIL(R) GARDASIL(R) 0.5 mL injection in 3 dose regimen

Eligibility

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

Criteria

Inclusion Criteria:

Female between 16- to 26-years-old
Has never had Pap testing or has only had normal Pap test results

Exclusion Criteria:

History of an abnormal cervical biopsy result
History of a positive test for HPV
History of external genital/vaginal warts
Currently a user of any illegal drugs or an alcohol abuser
History of severe allergic reaction that required medical attention
Are pregnant
Currently enrolled in a 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: NCT00543543

Contacts

Contact: Toll Free Number

1-888-577-8839

Show 20 Study Locations

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_538, V503-001
Study First Received:	October 12, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00543543
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Vaginal Neoplasms
Sexually Transmitted Diseases, Viral
Skin Diseases
Condyloma
Genital Neoplasms, Female
Vaginal cancer
Vaginal Diseases
Urogenital Neoplasms
Genital Diseases, Female
Virus Diseases

Skin Diseases, Infectious
Warts
Vulvar Neoplasms
Condyloma acuminatum
Condylomata Acuminata
Sexually Transmitted Diseases
Papillomavirus Infections
DNA Virus Infections
Vulvar Diseases
Vulvar cancer

Additional relevant MeSH terms:

Skin Diseases, Viral
Neoplasms
Neoplasms by Site
Tumor Virus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009