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

Analysis of trends over time of hepatitis related incidence in Panama

GSK study ID
112263
See study documents
Clinicaltrials.gov ID
NCT01159951
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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
    Primary completion date:
    2011-25-08
    Observational study model:
    Other
    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
    Inclusion and exclusion 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

    Trial location(s)

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

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

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

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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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