Last updated: 11/07/2018 04:27:26

Surveillance study to determine the trends in acute hepatitis A among Panamanian children

GSK study ID
112158
See study documents
Clinicaltrials.gov ID
NCT01159925
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: Epidemiologic surveillance to assess trends in acute hepatitis A among children in Panama
Trial description: The purpose of this study is to collect epidemiological and clinical data to assess the vaccine impact and occurrence of confirmed acute hepatitis A cases in sentinel hospitals after the introduction of Havrix™ into the Expanded Program of Immunization.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of confirmed acute hepatitis A cases identified in the selected sentinel hospitals during the study period by age group, area of residence and year of surveillance

Timeframe: average time-frame: 2.5 years

Secondary outcomes:

Occurrence of possible and probable cases of acute hepatitis A virus by age group, area of residence and year of surveillance

Timeframe: average time-frame: 2.5 years

Risk factors for confirmed cases of acute hepatitis A

Timeframe: average time-frame: 2.5 years

Frequency of different clinical signs and symptoms of hepatitis A

Timeframe: average time-frame: 2.5 years

Interventions:
  • Procedure/surgery: Serum sample
    • Enrollment:
    42
    Primary completion date:
    2011-30-12
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    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
    Acute hepatitis A
    Product
    SB208109
    Collaborators
    Not applicable
    Study date(s)
    July 2009 to December 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    1 months - 15 years
    Accepts healthy volunteers
    No
    • A male or female between >1 month and <15 years of age at the time of enrolment, being referred to any of the 3 participating sentinel hospitals.
    • Subjects with clinical diagnosis of possible acute hepatitis A.
    • Subjects with confirmed diagnosis of non-viral hepatitis
    Inclusion and exclusion criteria
    Inclusion criteria:

      A male or female between >1 month and <15 years of age at the time of enrolment, being referred to any of the 3 participating sentinel hospitals.

      • Subjects with clinical diagnosis of possible acute hepatitis A.
      • Written informed consent obtained from the parent or guardian of the subject.
      • Subjects for whom a blood sample is collected.
    Exclusion criteria:

      Subjects with confirmed diagnosis of non-viral hepatitis

    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
    2011-30-12
    Actual study completion date
    2011-30-12

    Plain language summaries

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

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website