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

NCT ID: NCT01159925

Last Updated: 2012-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-12-31

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.

Conditions

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Acute Hepatitis A Hepatitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Possible hepatitis A Cohort

Children with an acute disease characterized by discrete onset of symptoms and jaundice

Serum sample

Intervention Type PROCEDURE

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

Serum sample

Intervention Type PROCEDURE

Serum samples collected

Confirmed hepatitis A Cohort

Children presenting a positive result for Immunoglobulin M for hepatitis A virus

Serum sample

Intervention Type PROCEDURE

Serum samples collected

Interventions

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Serum sample

Serum samples collected

Intervention Type PROCEDURE

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Clayton, Provincia de Panamá, Panama

Site Status

Countries

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Panama

References

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Estripeaut D, Contreras R, Tinajeros O, Castrejon MM, Shafi F, Ortega-Barria E, DeAntonio R. Impact of Hepatitis A vaccination with a two-dose schedule in Panama: Results of epidemiological surveillance and time trend analysis. Vaccine. 2015 Jun 22;33(28):3200-7. doi: 10.1016/j.vaccine.2015.04.100. Epub 2015 May 14.

Reference Type DERIVED
PMID: 25981490 (View on PubMed)

Other Identifiers

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112158

Identifier Type: -

Identifier Source: org_study_id