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

Completed

• Conditions: Hepatitis; Acute Hepatitis A
• Interventions: Procedure: Serum sample

• Registration Number: NCT01159925
• Lead Sponsor: GlaxoSmithKline

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 of Havrix™ into the Expanded Program of Immunization.

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 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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-07-08
• Study First Submitted QC: 2010-07-08
• Study First Posted: 2010-07-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-21
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Possible hepatitis A Cohort	Serum sample	Children with an acute disease characterized by discrete onset of symptoms and jaundice
Probable hepatitis A Cohort	Serum sample	Children with an increase in serum levels of transaminase 2.5 times higher than the maximum limit of the normal interval
Confirmed hepatitis A Cohort	Serum sample	Children presenting a positive result for Immunoglobulin M for hepatitis A virus

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇦 Clayton, Panamá, Panama