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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01544478
First received: February 29, 2012
Last updated: March 23, 2017
Last verified: March 2017
February 29, 2012
March 23, 2017
November 22, 2011
August 27, 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 ]
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
Not Provided
Not Provided
Not Provided
 
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
Intervention Model: Single Group Assignment
Masking: No masking
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.
 
Completed
1030
August 27, 2016
August 27, 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
Sexes Eligible for Study: Female
16 Years to 26 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT01544478
V501-110
132247 ( Registry Identifier: Japic-CTI )
No
Not Provided
Yes

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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2017

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