Status:
COMPLETED
Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Cervical Cancer
Genital Warts
Eligibility:
FEMALE
16-23 years
Phase:
PHASE3
Brief Summary
The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent cervical cancer.
Detailed Description
In the 4-year Base Study (V501-015) (NCT00092534), participants were randomized in a 1:1 order to receive 3 doses of GARDASIL™ or matching placebo at Day 1, Month 2, and Month 6 and were assessed for ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for the Base Study:
- Healthy women with an intact uterus with lifetime history of 0-4 sexual partners
- -For Extension Phase:
- Participant received placebo or an incomplete vaccination series in the original study
- -For LTFU:
- Participant was randomized into the Base Study from Denmark, Iceland, Norway, or Sweden.
- Agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from National Registry Study Center and serum collection
- Exclusion Criteria for the Base Study:
- Prior Human Papilloma Virus (HPV) vaccination
- Prior abnormal Paps
- Prior history of genital warts
- -For Extension Phase:
- Prior complete HPV vaccination series
- Subject lives in a country in which Gardasil is approved and is within the age range of the local labeling for Gardasil
- -For LTFU Study:
- There were no exclusion criteria that did not overlap the inclusion criteria for this study.
Exclusion
Key Trial Info
Start Date :
June 14 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2025
Estimated Enrollment :
12167 Patients enrolled
Trial Details
Trial ID
NCT00092534
Start Date
June 14 2002
End Date
June 13 2025
Last Update
August 1 2025
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