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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Hepatitis A

Treatments: Biological: Hepatitis A

Study type: Observational

Funder types: Industry

Identifiers

NCT00237991

104147

Details and patient eligibility

About

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).

Full description

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

Sex: All

Volunteers: Accepts Healthy Volunteers

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).