NCT01159925

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 1 Month – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Hepatitis A
• Hepatitis

Interventions

Type	Name	Description
PROCEDURE	Serum sample	Serum samples collected

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-07-12
• Last updated: 2012-11-22

Locations

1 site across 1 country: Panama