Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00092521 |
Recruitment Status :
Completed
First Posted : September 28, 2004
Results First Posted : November 20, 2009
Last Update Posted : September 25, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Cancer Genital Warts | Biological: V501 Biological: Comparator: Placebo Biological: Human Papillomavirus (HPV) 16 Monovalent | Phase 3 |
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 |

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. |
- 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) ]
- 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) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years to 23 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00092521 |
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 |
Warts Condylomata Acuminata Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |
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 |