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

November 21, 2012 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
    • Panamá
      • Clayton, Panamá, Panama
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children aged >1 month and <15 years of age being seen for possible acute hepatitis A during the study time period at the selected sentinel hospitals of Panama

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: average time-frame: 2.5 years
average time-frame: 2.5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

July 8, 2010

First Posted (Estimate)

July 12, 2010

Study Record Updates

Last Update Posted (Estimate)

November 22, 2012

Last Update Submitted That Met QC Criteria

November 21, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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