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Completed

NCT Number: NCT00517309

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

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

Completed

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Key information

Conditions

Cervical Cancer Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Genital Warts Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases Warts

Age range

16 year–23 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years

Biological

Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years

Biological

Primary outcomes

  1. Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.

Secondary outcomes

  1. HPV vaccine is well tolerated in 16-23 year old females.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Acronym: FUTURE

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Aug 16, 2007
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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