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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01159925
First received: July 8, 2010
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Acute Hepatitis A
Hepatitis
 Procedure: Serum sample

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Epidemiologic Surveillance to Assess Trends in Acute Hepatitis A Among Children in Panama

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Risk factors for confirmed cases of acute hepatitis A [ Time Frame: average time-frame: 2.5 years ] [ Designated as safety issue: No ]
  • Frequency of different clinical signs and symptoms of hepatitis A [ Time Frame: average time-frame: 2.5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Enrollment: 42
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   1 Month to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159925

Locations
Panama
GSK Investigational Site
Clayton, Panamá, Panama
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01159925     History of Changes
Other Study ID Numbers: 112158
Study First Received: July 8, 2010
Last Updated: November 21, 2012
Health Authority: Panama: Ministerio de Salud

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on June 17, 2013