Analysis of Trends Over Time of Hepatitis Related Incidence in Panama
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01159951
First received: July 8, 2010
Last updated: November 10, 2011
Last verified: November 2011
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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 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 May 21, 2013