Status:
COMPLETED
Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults
Lead Sponsor:
Novartis Vaccines
Conditions:
Tick Born Encephalitis
Eligibility:
All Genders
15-68 years
Phase:
PHASE4
Brief Summary
evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster
Eligibility Criteria
Inclusion
- healthy subjects who have completed study V48P7
Exclusion
- acute illness at day of immunization
- general decrease in resistance
- progressive neurological disorders
- history of febrile or afebrile convulsions
- major congenital defects
- serious chronic illness
- hypersensitivity to study vaccine
- treatment with immunosuppressants or systemic corticosteroids, immunoglobulins, whole blood or plasma derivates
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT00387634
Start Date
September 1 2006
End Date
October 1 2011
Last Update
November 2 2012
Active Locations (1)
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1
Hradec Králové, Czechia, 500 03