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

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

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GSK study ID
104147
See study documents
Clinicaltrials.gov ID
NCT00237991
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: 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
Observational study model:
Not applicable
Primary completion date:
2005-30-12
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.
Inclusion and exclusion criteria
Inclusion criteria:

    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.
    • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
    • Written informed consent is obtained from the subject/ subjects’ parents or guardians. Exclusion criteria
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral temperature < 37.5°C (99.5°F) / Axillary temperature < 37.5°C (99.5°F) / Rectal temperature < 38°C (100.4°F) / Tympanic temperature on oral setting < 37.5°C (99.5°F) / Tympanic temperature on rectal setting < 38°C (100.4°F).

Trial location(s)

No location data available.

Study documents

Scientific result summary
Available language(s): English
Download document(s)
Clinical study report
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
Finalized
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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