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Safety of GlaxoSmithKline (GSK) Biologicals Hepatitis A Vaccine in Korean Population
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00237991
  Purpose

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).


Condition Intervention
Hepatitis A
Biological: Hepatitis A

MedlinePlus related topics: Hepatitis Hepatitis A
Drug Information available for: Hepatitis A Vaccines
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: A Multicentric, Post-Marketing Surveillance to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals Hepatitis A Vaccine Administered in Korean Population.

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment: 600
Study Start Date: June 2005
Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237991

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: 104147
Study First Received: October 12, 2005
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00237991  
Health Authority: Korea: Food and Drug Administration

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Picornaviridae Infections
Hepatitis, Viral, Human
Hepatitis A
Enterovirus Infections

Additional relevant MeSH terms:
RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009