Analysis of Trends Over Time of Hepatitis Related Incidence in Panama

June 6, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
    • Panamá
      • Clayton, Panamá, Panama
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The target population to be studied will be all subjects reported with hepatitis related outcomes to the Epidemiologic Surveillance System of the Ministry of Health of Panama, between 2000 and 2010.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hepatitis Cohort
Subjects suffering with hepatitis
Other: Epidemiologic Surveillance System of the Ministry of Health of Panama
Systematic review of the databases of epidemiologic surveillance system, Ministry of health, Panama

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by year
Time Frame: From year 2000 until year 2010
From year 2000 until year 2010
Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by age groups
Time Frame: From year 2000 until year 2010
From year 2000 until year 2010
Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by region
Time Frame: From year 2000 until year 2010
From year 2000 until year 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

July 8, 2010

First Posted (Estimate)

July 12, 2010

Study Record Updates

Last Update Posted (Actual)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112263

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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