Surveillance Study to Determine the Trends in Acute Hepatitis A Among Panamanian Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Epidemiologic Surveillance to Assess Trends in Acute Hepatitis A Among Children in Panama

Conditions
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Acute Hepatitis A, Hepatitis

Intervention / Treatment
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* Procedure: Serum sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Possible hepatitis A Cohort<br>Children with an acute disease characterized by discrete onset of symptoms and jaundice | Procedure: Serum sample<br>* Serum samples collected<br>|
| Probable hepatitis A Cohort<br>Children with an increase in serum levels of transaminase 2.5 times higher than the maximum limit of the normal interval | Procedure: Serum sample<br>* Serum samples collected<br>|
| Confirmed hepatitis A Cohort<br>Children presenting a positive result for Immunoglobulin M for hepatitis A virus | Procedure: Serum sample<br>* Serum samples collected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of confirmed acute hepatitis A cases identified in the selected sentinel hospitals during the study period by age group, area of residence and year of surveillance |  | average time-frame: 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of possible and probable cases of acute hepatitis A virus by age group, area of residence and year of surveillance |  | average time-frame: 2.5 years | 
| Risk factors for confirmed cases of acute hepatitis A |  | average time-frame: 2.5 years | 
| Frequency of different clinical signs and symptoms of hepatitis A |  | average time-frame: 2.5 years |