Last updated: 11/07/2018 04:35:11

Analysis of trends over time of hepatitis related incidence in Panama

GSK study ID
112263
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of reported hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis)

Timeframe: In post vaccine introduction period (2008-2010) compared to pre-vaccination period (2000-2007)

Secondary outcomes:

Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by year

Timeframe: From year 2000 until year 2010

Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by age groups

Timeframe: From year 2000 until year 2010

Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by region

Timeframe: From year 2000 until year 2010

Interventions:
Other: Epidemiologic Surveillance System of the Ministry of Health of Panama
Enrollment:
1
Observational study model:
Other
Primary completion date:
2011-25-08
Time perspective:
Retrospective
Clinical publications:
Estripeaut D et al. (2015) Impact of Hepatitis A vaccination with a two-dose schedule in Panama: Results of epidemiological surveillance and time trend analysis. Vaccine. 33(28):3200-3207.
Medical condition
Hepatitis
Product
SB208109
Collaborators
Not applicable
Study date(s)
January 2009 to August 2011
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
0+ years
Accepts healthy volunteers
No
  • 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
  • Not applicable

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Clayton, Panamá, Panama
Status
Study Complete

Study documents

Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2011-25-08
Actual study completion date
2011-25-08

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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