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

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.
ClinicalTrials.gov Identifier: NCT01544478
Recruitment Status : Completed
First Posted : March 6, 2012
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Cervical Intraepithelial Neoplasia Adenocarcinoma in Situ Biological: V501 Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1030 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : November 25, 2011
Primary Completion Date : August 27, 2016
Study Completion Date : August 27, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: V501
Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
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™


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544478


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01544478     History of Changes
Other Study ID Numbers: V501-110
132247 ( Registry Identifier: Japic-CTI )
2015-002932-42 ( EudraCT Number )
First Posted: March 6, 2012    Key Record Dates
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
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


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

Additional relevant MeSH terms:
Adenocarcinoma
Uterine Cervical Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Adenocarcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female