Status:
COMPLETED
HPV Vaccine Effectiveness in Partially Vaccinated Girls in Uganda
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
HPV16 Anitbody Levels Post Vaccination
HPV18 Antibody Levels Post Vaccination
Eligibility:
FEMALE
12-20 years
Brief Summary
Background: \- Cervical cancer is one of the leading causes of cancer death in women worldwide and in Uganda. It is caused by the human papillomavirus (HPV). A vaccine against HPV was offered for all...
Detailed Description
Background: Recent experience with HPV vaccine implementation in low resource settings has suggested that high vaccine coverage for all three doses could be achieved provided programs are planned wel...
Eligibility Criteria
Inclusion
- 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 (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.
Exclusion
Key Trial Info
Start Date :
January 2 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 28 2017
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT01520272
Start Date
January 2 2012
End Date
June 28 2017
Last Update
April 5 2018
Active Locations (1)
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1
District of Nakasangola
Kampala, Uganda