Analysis of Trends Over Time of Hepatitis Related Incidence in Panama

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01159951
First received: July 8, 2010
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Hepatitis
Other: Epidemiologic Surveillance System of the Ministry of Health of Panama

Study Type: Observational
Study Design: Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by year [ Time Frame: From year 2000 until year 2010 ] [ Designated as safety issue: No ]
  • Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by age groups [ Time Frame: From year 2000 until year 2010 ] [ Designated as safety issue: No ]
  • Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by region [ Time Frame: From year 2000 until year 2010 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

No samples retained


Enrollment: 1
Study Start Date: January 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159951

Locations
Panama
GSK Investigational Site
Clayton, Panamá, Panama
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01159951     History of Changes
Other Study ID Numbers: 112263
Study First Received: July 8, 2010
Last Updated: November 10, 2011
Health Authority: Panama: Ministerio de Salud

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on September 18, 2014