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COMPLETEDPhase 3NCT00834106

Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)

A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine type-specifi...

Lead sponsor: Merck Sharp & Dohme LLC•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Merck Sharp & Dohme LLC

The Base Study V501-041 duration was 30 months. The study was extended to further evaluate the efficacy of Quadrivalent HPV (Type 6, 11, 16, 18) L1 VLP (qHPV) vaccine against Cervical Intraepithelial Neoplasia Grade 2 (CIN 2), CIN 3, Adenocarcinoma In Situ (AIS), and/or cervical cancer. The efficacy was followed through the Month 78 visit, and the close-out visit was conducted at approximately Month 90 with only safety data collected

Age

20 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy women between the ages of 20 and 45
•Have used effective contraception for 2 weeks prior to starting in the study
•Does not have a temperature within 24 hours before the first injection

Exclusion Criteria

•Prior history of genital warts
•More than 4 lifetime sexual partners
•Have undergone hysterectomy
•Have active cervical disease or history of cervical disease

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 4, 2019Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment3,006

Start dateDec 2008

Last updatedFeb 4, 2019

Condition

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2019Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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