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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
Enterovirus Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014