Status:
COMPLETED
Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
6+ years
Phase:
PHASE4
Brief Summary
The present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of Korean Food and Drugs Administration (KFDA).
Eligibility Criteria
Inclusion
- A male or female \> 6 months of age at the time of the first vaccination.
- Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- Free of obvious health problems as established by medical history and clinical examination judged by the investigator before entering into the study.
- If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.
Exclusion
- Clinical signs of acute febrile illness at the time of entry into the study.
- Any treatment with immunosuppressive drugs, including oral and parenteral corticosteroids.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or previous severe reaction to influenza virus vaccine.
Key Trial Info
Start Date :
October 3 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2007
Estimated Enrollment :
883 Patients enrolled
Trial Details
Trial ID
NCT00750360
Start Date
October 3 2003
End Date
December 28 2007
Last Update
November 6 2018
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