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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:
ClinicalTrials.gov Identifier:
NCT01544478
First Posted: March 6, 2012
Last Update Posted: July 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
February 29, 2012
March 6, 2012
June 8, 2017
July 7, 2017
July 7, 2017
November 25, 2011
August 27, 2016   (Final data collection date for primary outcome measure)
Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 [ Time Frame: Up to Month 48 ]
The endpoint included 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. The point estimates and exact 95% confidence intervals for incidence rate were based on the Poisson distribution.
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
Complete list of historical versions of study NCT01544478 on ClinicalTrials.gov Archive Site
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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 evaluated 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: None (Open Label)
Primary Purpose: Prevention
  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia
  • Adenocarcinoma in Situ
Biological: V501
HPV 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
Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
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 (HIV)
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 )
2015-002932-42 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2017

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