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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00237991
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : October 16, 2008
Sponsor:
Information provided by:

Study Description
Brief 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).

Condition or disease Intervention/treatment
Hepatitis A Biological: Hepatitis A

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

Study Design

Study Type : Observational
Estimated Enrollment : 600 participants
Time Perspective: Prospective
Official Title: A Multicentric, Post-Marketing Surveillance to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals Hepatitis A Vaccine Administered in Korean Population.
Study Start Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00237991


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

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00237991     History of Changes
Other Study ID Numbers: 104147
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: October 16, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections