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

Hepatitis A Clinical Trial

Official title:

A Multicentric, Post-Marketing Surveillance to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals Hepatitis A Vaccine Administered in Korean Population.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237991
• Other study ID #: 104147
• Status: Completed
• Phase: N/A
• First received: October 12, 2005
• Last updated: October 15, 2008
• Start date: June 2005

Study information

• Verified date: October 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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).

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

Intervention

Biological:
• Hepatitis A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline