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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00834106
First received: January 30, 2009
Last updated: March 20, 2017
Last verified: March 2017
  Purpose
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-specific genital disease among Chinese females between the ages of 20 and 45.

Condition Intervention Phase
HPV Infections Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Biological: Comparator: placebo (unspecified) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
Official Title: A Randomized, Placebo-Controlled, Double-Blind Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine to Investigate the Safety, and Efficacy in Chinese 20 - to 45-Years-Old Women

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants with persistent HPV 6, 11, 16 or 18 infection, or HPV 6/11/16/18-related genital disease [ Time Frame: Up to Month 30 ]
  • Number of participants with CIN2, CIN3, AIS, and/or cervical cancer [ Time Frame: Up to Month 78 ]

Enrollment: 3006
Actual Study Start Date: December 31, 2008
Study Completion Date: September 30, 2016
Primary Completion Date: May 11, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: qHPV
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine injection at Day 1, Month 2, and Month 6.
Other Name: Gardasil ™
Placebo Comparator: Placebo Biological: Comparator: placebo (unspecified)
Aluminum-containing Vaccine placebo injection at Day 1, Month 2, and Month 6.

Detailed Description:
The Base Study V501-041 had a planned duration of 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 total duration of the study extension is expected to be approximately 48 months, until the requisite number of primary efficacy endpoint cases (HPV 16/18-related CIN 2 or worse) has accrued over the total study period (base study and extension).
  Eligibility

Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834106

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00834106     History of Changes
Other Study ID Numbers: V501-041
2009_532
Study First Received: January 30, 2009
Last Updated: March 20, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Keywords provided by Merck Sharp & Dohme Corp.:
HPV 6/11/16/18 Infection

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 27, 2017