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NCT01159951 Clinical Trial

Analysis of Trends Over Time of Hepatitis Related Incidence in Panama

Hepatitis Clinical Trial

Official title:
Time Trend Analysis of the Incidence of Hepatitis- Related Outcomes (Viral Hepatitis A and Unspecified Viral Hepatitis) Reported to the Surveillance System of Panama, 2000-2010

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01159951
Other study ID # 112263
Secondary ID
Status Completed
Phase N/A
First received July 8, 2010
Last updated June 6, 2017
Start date January 2009
Est. completion date August 2011

Study information
Verified date June 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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:

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Epidemiologic Surveillance System of the Ministry of Health of Panama
Systematic review of the databases of epidemiologic surveillance system, Ministry of health, Panama

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