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• 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).
  

  
  

  status:	completed
  conditions:	Hepatitis A
  interventions:	Hepatitis A
  phase:	N/A
  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)

  enrollment: 600

  study start date: June 2005

  
  

  Detailed description

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

• Eligibility

  ages eligible for study:
  genders eligible for study:	Both

  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:

  GSK Clinical Trials, Study Director, GlaxoSmithKline

• More information

  first received:	October 12, 2005
  last updated:	October 15, 2008
  ClinicalTrials.gov Identifier:	NCT00237991
  health authority:	Korea: Food and Drug Administration

Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

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