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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01159925

Enrollment

Registered

2010-07-12

Start date

2009-07-31

Completion date

2011-12-31

Last updated

2012-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hepatitis A, Hepatitis

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.

Interventions

PROCEDURESerum sample

Serum samples collected

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 15 Years

Healthy volunteers

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

Design outcomes

Primary

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	average time-frame: 2.5 years

Secondary

Measure	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

Countries

Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026