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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01544478
First received: February 29, 2012
Last updated: May 20, 2014
Last verified: May 2014

February 29, 2012
May 20, 2014
November 2011
May 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01544478 on ClinicalTrials.gov Archive Site
Not Provided
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V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)
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

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia
  • Adenocarcinoma in Situ
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™
Experimental: V501
Intervention: Biological: V501
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
May 2016
May 2016   (final data collection date for primary outcome measure)

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
Female
16 Years to 26 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01544478
V501-110, 132247
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP