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Completed

NCT Number: NCT01159925

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

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.

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Key information

Conditions

Acute Hepatitis A Digestive System Diseases Hepatitis Liver Diseases

Age range

1 month–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Clayton, Provincia de Panamá, Panama

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum sample

Procedure

Serum samples collected

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Risk factors for confirmed cases of acute hepatitis A

    Time frame: average time-frame: 2.5 years

  3. Frequency of different clinical signs and symptoms of hepatitis A

    Time frame: average time-frame: 2.5 years

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 12, 2010
Registry last updated
Nov 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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