Follow-up Study of GSK Biologicals' Human Papilloma Virus (HPV) Vaccine to Prevent Cervical Infection in Young Adults

Completed · Phase 2

Conditions studied: Infections, Papillomavirus

In brief

Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This is an observer blind follow up study of the study HPV-001, which evaluated the ability of the HPV vaccine to prevent HPV infection. The current study invites all of the 1113 subjects in the HPV-001 study that received all three doses of vaccine/placebo to be enrolled and followed-up for several additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to evaluate the safety of the vaccine. Subjects will remain in the same study group as in the primary study. No vaccine or placebo will be administered in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Key facts

Study ID

NCT00120848

Run by

GlaxoSmithKline

People needed

776

Starts

2003-11-01

Expected to finish

2007-07-01

Last updated by the study team

2016-11-04

Who can join

Age: 20 and older, up to 30. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Participated in study 580299/001 and received all three doses of vaccine/placebo.
• Written informed consent obtained from the subject prior to enrollment

You may not qualify if…

• Decoding of the subject's treatment allocation to either the subject or the investigator in study 580299/001.

Where it is running

• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Augusta, Georgia, United States
• GSK Investigational Site — Bardstown, Kentucky, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Lebanon, New Hampshire, United States
• GSK Investigational Site — Morristown, New Jersey, United States
• GSK Investigational Site — Albuquerque, New Mexico, United States
• GSK Investigational Site — Portland, Oregon, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Salt Lake City, Utah, United States
• GSK Investigational Site — West Jordan, Utah, United States
• GSK Investigational Site — Seattle, Washington, United States
• GSK Investigational Site — Marshfield, Wisconsin, United States
• GSK Investigational Site — Curitiba, Paraná, Brazil
• GSK Investigational Site — Porto Alegre, Rio Grande do Sul, Brazil
• GSK Investigational Site — São Paulo, São Paulo, Brazil
• GSK Investigational Site — Campinas, Brazil
• GSK Investigational Site — Fortaleza, Brazil
• GSK Investigational Site — Edmonton, Alberta, Canada
• GSK Investigational Site — Langley, British Columbia, Canada
• GSK Investigational Site — Winnipeg, Manitoba, Canada

Full record on ClinicalTrials.gov

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