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

Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159925
• Other study ID #: 112158
• Status: Completed
• Phase: N/A
• First received: July 8, 2010
• Last updated: November 21, 2012
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Panama: Ministerio de Salud
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 15 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Hepatitis A
• Hepatitis
• Hepatitis A

Intervention

Procedure:
• Serum sample
Serum samples collected

Locations

Country	Name	City	State
Panama	GSK Investigational Site	Clayton	Panamá

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Risk factors for confirmed cases of acute hepatitis A		average time-frame: 2.5 years	No
Secondary	Frequency of different clinical signs and symptoms of hepatitis A		average time-frame: 2.5 years	No