Infections, Papillomavirus Clinical Trial
Official title:
Study of the Efficacy of Candidate HPV 16/18 VLP Vaccine in the Prevention of HPV-16 and/or HPV-18 Cervical Infection in Adolescent & Young Adult Women in North America and Brazil Vaccinated in Primary Study 580299/001
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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