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NCT00517309 Clinical Trial

Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)

Cervical Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00517309
Other study ID # V501-011
Secondary ID 2007_576
Status Completed
Phase Phase 3
First received August 15, 2007
Last updated March 20, 2017
Start date December 28, 2001
Est. completion date June 11, 2004

Study information
Verified date March 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of the study is to test the safety of HPV Vaccine in Women

Recruitment information / eligibility
Status Completed
Enrollment 1877
Est. completion date June 11, 2004
Est. primary completion date June 8, 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years to 23 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• 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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (2)

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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.
Secondary HPV vaccine is well tolerated in 16-23 year old females.
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