Surveillance Study to Determine the Trends in Acute Hepatitis A Among Panamanian Children
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About
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 of Havrix™ into the Expanded Program of Immunization.
Full 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 Health Organization (PAHO) definition for a possible case of acute hepatitis A are used for subjects aged between >1 month and <15 years.
Data regarding clinical and epidemiologic information are collected and serum samples are collected to test hepatitis A markers and determine if infection with hepatitis A virus has recently occurred.
Surveillance will be for a period of approximately 2.5 years from the date of study initiation.
Enrollment
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Volunteers
Inclusion criteria
- 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 criteria
- Subjects with confirmed diagnosis of non-viral hepatitis
Trial design
42 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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