V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01544478

First received: February 29, 2012

Last updated: May 24, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 29, 2012
Last Updated Date	May 24, 2012
Start Date ^ICMJE	November 2011
Estimated Primary Completion Date	May 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 29, 2012)	Combined incidence of CIN 2/3 or worse related to HPV type 6, 11, 16, or 18 [ Time Frame: Up to Month 48 postvaccination ] [ Designated as safety issue: No ] Pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, AND HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01544478 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)
Official Title ^ICMJE	A Phase IV Open-Label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women
Brief Summary	This study will evaluate the long term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Cervical Cancer Cervical Intraepithelial Neoplasia Adenocarcinoma in Situ
Intervention ^ICMJE	Biological: V501 Human Papillomavirus types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6 Other Name: Gardasil™
Study Arm (s)	Experimental: V501 Intervention: Biological: V501
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	1000
Estimated Completion Date	May 2016
Estimated Primary Completion Date	May 2016 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Healthy Japanese females Not pregnant at Screening and agree to use effective contraception through Month 7 of the study Lifetime history of 0 to 4 male or female sexual partners No oral temperature ≥37.5 centigrade within 24 hours prior to injection Exclusion Criteria: Received a marketed HPV vaccine Prior abnormal papanicolaou smear (PAP)or biopsy showing CIN Known history of positive test for HPV Known history of genital warts Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study History of splenectomy, known immune disorders, or receiving immunosuppressives Immunocompromised or diagnosed as having human immunodeficiency virus
Gender	Female
Ages	16 Years to 26 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01544478
Other Study ID Numbers ^ICMJE	V501-110
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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