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

NCT01159925 | Completed

• 1 other identifier: 112158
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Hepatitis A; Hepatitis

Outcome Measures

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

  average time-frame: 2.5 years

Secondary Outcomes (3)

• 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

Study Arms (3)

Possible hepatitis A Cohort

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

Procedure: Serum sample

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

Confirmed hepatitis A Cohort

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

Procedure: Serum sample

Interventions

Serum sample PROCEDURE

Serum samples collected

Confirmed hepatitis A Cohort; Possible hepatitis A Cohort; Probable hepatitis A Cohort

Eligibility Criteria

• Age: 1 Month - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Subjects with confirmed diagnosis of non-viral hepatitis

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Clayton, Provincia de Panamá, Panama

Location

Related Publications (1)

• 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.

  PMID: 25981490 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Hepatitis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 12, 2010
• Study Start: July 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 22, 2012

Record last verified: 2012-11

Locations

PA (1)