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About
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety and immunogenicity of Cervarix in HIV infected females aged 15 to 25 years as compared to Merck's HPV vaccine (Gardasil). For comparative purposes, a group of HIV negative females will also be evaluated. All subjects will receive the HPV vaccine (either Cervarix or Gardasil) according to a three-dose schedule (Day 0, Week 6, Month 6).
Enrollment
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Inclusion criteria
Subjects who the investigator believes that they and/or their parent(s)/legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol.
A female between, and including, 15 and 25 years of age at the time of the first vaccination.
Written informed consent obtained from the subject and/or from the subject's parent or LAR.
Subjects willing to undergo HIV Voluntary Counseling and Testing (VCT) and willing to be informed of their HIV infection status.
For HIV seropositive subjects:
For HIV seronegative subjects:
For non-virgin female subjects:
Subjects must have no history of congenital malformations of the uterine cervix, or history of cauterization or surgical procedures involving damage to the transformation zone of the cervix or stenosis.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
873 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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