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Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00092521
Recruitment Status : Completed
First Posted : September 28, 2004
Results First Posted : November 20, 2009
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.

Condition or disease Intervention/treatment Phase
Cervical Cancer Genital Warts Biological: V501 Biological: Comparator: Placebo Biological: Human Papillomavirus (HPV) 16 Monovalent Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5759 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Efficacy of Quadrivalent HPV Vaccine in Reducing the Incidence of HPV 6-, 11-, 16-, and 18-Related CIN, AIS, and Cervical Cancer, and HPV 6-, 11-, 16-, and 18-Related External Genital Warts, Vulvar Intraepithelial Neoplasia Vaginal Intraepithelial Neoplasia, Vulvar Cancer, and Vaginal Cancer in 16- to 23-Year-Old Women
Study Start Date : December 2001
Actual Primary Completion Date : July 2007
Actual Study Completion Date : January 2009

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
V501
 Biological: V501
Final Manufactured Product (FMP) quadrivalent HPV vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
Placebo Comparator: 2
Placebo
 Biological: Comparator: Placebo
a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6.
Experimental: 3
HPV 16 Monovalent Vaccine
 Biological: Human Papillomavirus (HPV) 16 Monovalent
HPV 16 Monovalent vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer [ Time Frame: Follow-up through end of study (4 years) ]
  2. Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer] [ Time Frame: Follow-up through end of study (4 years) ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria:

  • Prior Human Papillomavirus (HPV) vaccination
  • Prior abnormal paps
  • History of genital warts
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092521


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092521     History of Changes
Other Study ID Numbers: V501-013
2004_081
First Posted: September 28, 2004    Key Record Dates
Results First Posted: November 20, 2009
Last Update Posted: September 25, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Warts
Condylomata Acuminata
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Papillomavirus Infections
DNA Virus Infections
 Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vaccines
Immunologic Factors
Physiological Effects of Drugs