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Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00092482
Recruitment Status : Completed
First Posted : September 27, 2004
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.

Condition or disease Intervention/treatment Phase
Cervical Cancer Genital Warts Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3882 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Consistency Lots for 16- to 23-Year-Old Women With and Additional Immunogenicity Bridge to the Monovalent HPV 16 Vaccine Pilot Manufacturing Lot Study-The F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)
Actual Study Start Date : June 28, 2002
Primary Completion Date : June 30, 2004
Study Completion Date : August 15, 2008
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Tolerability and immune responses at week 4 post dose 3.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria:

  • Prior Human Papillomavirus Vaccine (HPV) vaccination;
  • Prior abnormal paps;
  • Prior history of genital warts
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): NCT00092482


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

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092482     History of Changes
Other Study ID Numbers: V501-012
2004_080
First Posted: September 27, 2004    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Condylomata Acuminata
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs