Analysis of Trends Over Time of Hepatitis Related Incidence in Panama

Completed

• Conditions: Hepatitis
• Interventions: Other: Epidemiologic Surveillance System of the Ministry of Health of Panama

• Registration Number: NCT01159951
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to analyze the incidence of baseline hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) together with the current frequency of the same outcome after introduction of Havrix™ in Panama.

Detailed Description

In this study, systematic review of the databases of epidemiologic surveillance system (Ministry of Health), for hepatitis related outcomes will be performed. The analysis will be performed by age group, years and country region.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-07-08
• Study First Submitted QC: 2010-07-08
• Study First Posted: 2010-07-12
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Hepatitis related outcomes occurred during the period analyzed and registered in the Epidemiologic Surveillance System of the Ministry of Health, will be collected for the study

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatitis Cohort	Epidemiologic Surveillance System of the Ministry of Health of Panama	Subjects suffering with hepatitis

Primary Outcome Measures

Name	Time	Method
Occurrence of reported hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis)	In post vaccine introduction period (2008-2010) compared to pre-vaccination period (2000-2007)

Secondary Outcome Measures

Name	Time	Method
Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by year	From year 2000 until year 2010
Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by age groups	From year 2000 until year 2010
Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by region	From year 2000 until year 2010

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇦 Clayton, Panamá, Panama