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Safety of GlaxoSmithKline (GS...

Safety of GlaxoSmithKline (GSK) Biologicals Hepatitis A Vaccine in Korean Population

Last Updated: 2008-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Brief Summary

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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).

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Detailed Description

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All subjects will be administered one dose of the hepatitis A vaccine.

Conditions

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Hepatitis A

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Hepatitis A

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes