HPV Vaccine Effectiveness in Partially Vaccinated Girls in Uganda

• INCLUSION CRITERIA:

The following inclusion criteria will be reviewed at the time of enrollment, and where noted, confirmed at the clinic visit, immediately prior to blood draw:

• Subject is aged 12-17 years as of August 31, 2011.
• Subject received at least one dose of HPV vaccine, Cervarix(Trademark) (GSK, UK), from October 1, 2008 through October 31, 2009 as a part of the PATH HPV vaccine demonstration project in Nakasongola, Uganda.
• Signed and dated informed written consent form (with both parent and subject's signatures) received (confirmed at clinic visit).
• Subject is afebrile, in good apparent health (confirmed at clinic visit).
• Subject assents to participate (confirmed at clinic visit).
• Subject is able to comply with the study protocol (confirmed at clinic visit).
• Subject plans to stay in Nakasongola for the duration of enrolment, which is expected to be about week between signed consent and blood draw.

EXCLUSION CRITERIA:

The following exclusion criteria will be reviewed at the time of enrollment, and where noted, confirmed at the clinic visit.

• Prior HPV vaccination outside the PATH HPV vaccine demonstration project period.
• Subject is known to be pregnant or lactating at the time of the scheduled blood draw (confirmed at clinic visit).
• Subject has an apparent moderate or severe acute illness or has fever (confirmed at clinic visit).
• Clinical history of bleeding disorders such as haemophilia, thrombocytopenia, or anticoagulant therapy.
• Investigational drug or investigational vaccine or licensed vaccine administered during the period from 30 days before the date of the scheduled blood draw (confirmed at clinic visit).
• Subject receives immunoglobulins and/or any blood products during the period from 30 days before the date of the scheduled blood draw (confirmed at clinic visit).
• Subject or subject's parents refused to sign written consent.
• Subject does not assent at the time of the blood draw.