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 a 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.

Condition	Intervention	Phase
Papillomavirus infections	Vaccine: HPV 16/18 VLP AS04	Phase II Phase III

Further Study Details: 

Primary Outcomes: To evaluate the long-term vaccine efficacy in the prevention of incident cervical infection with HPV-16 and/or HPV-18.
Secondary Outcomes: Long-term vaccine efficacy in the prevention of persistent cervical infection with HPV-16 and/or HPV-18; Safety during the study; Long-term vaccine efficacy in the prevention of persistent and incident infection with other oncogenic HPV types.
Expected Total Enrollment:  1113

Ages Eligible for Study:  20 Years   -   30 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Participated in primary study (HPV001) and received all three doses of vaccine/placebo.
• Written informed consent obtained from the subject prior to enrolment.

Exclusion Criteria:

• Knowledge of subject’s treatment allocation given to either the subject or the investigator (or designee) in the primary study (HPV-001)

Study chairs or principal investigators

Clinical Trials,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  580299/007
Last Updated:  August 1, 2005
Record first received:  July 18, 2005
ClinicalTrials.gov Identifier:  NCT00120848
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02