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

Launched by GLAXOSMITHKLINE · Oct 12, 2005

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility 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).