Last updated: 11/04/2019 11:00:13
Safety of GlaxoSmithKline (GSK) Biologicals hepatitis A vaccine in Korean population
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
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.
- 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:
- 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).
Inclusion criteria
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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