Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED) (FUTURE)
Primary Purpose
Cervical Cancer, Genital Warts
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years
Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- Females age 16 to 23 years old
- Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit
Exclusion Criteria:
- History of vaccination with an HPV vaccine
- History of hepatitis B infection
- History of vaccination with hepatitis B vaccine
- History of genital warts or treatment for genital warts
Sites / Locations
Outcomes
Primary Outcome Measures
Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.
Secondary Outcome Measures
HPV vaccine is well tolerated in 16-23 year old females.
Full Information
NCT ID
NCT00517309
First Posted
August 15, 2007
Last Updated
March 20, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00517309
Brief Title
Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)
Acronym
FUTURE
Official Title
Immunogenicity and Safety of Quadrivalent HPV L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women When Administered Alone or Concomitantly With Hepatitis B Vaccine (Recombinant)--the F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 28, 2001 (Actual)
Primary Completion Date
June 8, 2004 (Actual)
Study Completion Date
June 11, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
The primary purpose of the study is to test the safety of HPV Vaccine in Women
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Genital Warts
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1877 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years
Intervention Type
Biological
Intervention Name(s)
Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years
Primary Outcome Measure Information:
Title
Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.
Secondary Outcome Measure Information:
Title
HPV vaccine is well tolerated in 16-23 year old females.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Females age 16 to 23 years old
Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit
Exclusion Criteria:
History of vaccination with an HPV vaccine
History of hepatitis B infection
History of vaccination with hepatitis B vaccine
History of genital warts or treatment for genital warts
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18164106
Citation
Wheeler CM, Bautista OM, Tomassini JE, Nelson M, Sattler CA, Barr E; Protocol 11 study Investigators. Safety and immunogenicity of co-administered quadrivalent human papillomavirus (HPV)-6/11/16/18 L1 virus-like particle (VLP) and hepatitis B (HBV) vaccines. Vaccine. 2008 Jan 30;26(5):686-96. doi: 10.1016/j.vaccine.2007.11.043. Epub 2007 Dec 5.
Results Reference
background
PubMed Identifier
17955433
Citation
Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. doi: 10.1086/521679. Epub 2007 Sep 17.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)
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