Status:
COMPLETED
Surveillance Study to Determine the Trends in Acute Hepatitis A Among Panamanian Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Acute Hepatitis A
Hepatitis
Eligibility:
All Genders
1-15 years
Brief Summary
The purpose of this study is to collect epidemiological and clinical data to assess the vaccine impact and occurrence of confirmed acute hepatitis A cases in sentinel hospitals after the introduction ...
Detailed Description
This is an observational, prospective, multi-centre, sentinel based study in 3 hospitals in Panama. Hospitals are selected based on population density or hepatitis A disease burden. The Pan American ...
Eligibility Criteria
Inclusion
- A male or female between \>1 month and \<15 years of age at the time of enrolment, being referred to any of the 3 participating sentinel hospitals.
- Subjects with clinical diagnosis of possible acute hepatitis A.
- Written informed consent obtained from the parent or guardian of the subject.
- Subjects for whom a blood sample is collected.
Exclusion
- Subjects with confirmed diagnosis of non-viral hepatitis
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01159925
Start Date
July 1 2009
End Date
December 1 2011
Last Update
November 22 2012
Active Locations (1)
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1
GSK Investigational Site
Clayton, Provincia de Panamá, Panama