Last updated: 11/04/2019 11:00:13

Safety of GlaxoSmithKline (GSK) Biologicals hepatitis A vaccine in Korean population

GSK study ID
104147
Clinicaltrials.gov ID
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: A multicentric, post-marketing surveillance to monitor the safety and reactogenicity of GlaxoSmithKline Biologicals Hepatitis A vaccine administered in Korean population.
Trial description: GlaxoSmithKline Korea has submitted a registration file for its hepatitis A vaccine. The present study will collect clinical data in the local target population as per the requirement of Korean Food and Drugs administration (FDA).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Vaccine: Hepatitis A
  • Enrollment:
    600
    Primary completion date:
    2005-30-12
    Observational study model:
    Not applicable
    Time perspective:
    Prospective Study
    Clinical publications:
    Jae-Won C et al. (2008) Post-marketing surveillance study of hepatitis A vaccine in Korean population. Korean J pediatr infect dis. 15: 115-120.
    Medical condition
    Hepatitis A
    Product
    SB208109
    Collaborators
    Not applicable
    Study date(s)
    June 2005 to December 2005
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria
    • Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol (e.g. be reachable over the phone) should be enrolled in the study.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Clinical study report
    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
    Study complete
    Actual primary completion date
    2005-30-12
    Actual study completion date
    2005-30-12

    Plain language summaries

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

    Additional information about the trial

    Not applicable
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