Status:
UNKNOWN
Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine
Lead Sponsor:
Elisabethinen Hospital
Collaborating Sponsors:
Baxter Healthcare Corporation
ASOKLIF
Conditions:
Tick Borne Encephalitis
Eligibility:
All Genders
19-65 years
Phase:
PHASE2
Brief Summary
The study aims to answer this question: whether adequate immunity can be achieved in a short time, that is, by a rapid immunisation process, using at least one of 3 new TBE immunisation schedules? The...
Detailed Description
The data from at least 99 individuals will be needed if the study is to draw reliable conclusions. One-third of these individuals will receive 3 injections in all: 2 on the first day and the third inj...
Eligibility Criteria
Inclusion
- written informed consent
- FSME antibody level \< 7IU/ml (ELISA), retrospective
- FSME antibody (IgG) \< 63 VIEU/ml (ELISA), retrospective
- FSME antibody (IgM) negative
- FSME antibody inhibition capacity \<1:10-retrospective
- available for the next 56 days
Exclusion
- age not 19 or over 65
- pregnancy
- risk of becoming pregnant
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00890422
Start Date
March 1 2007
End Date
July 1 2010
Last Update
April 29 2009
Active Locations (2)
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1
Elisabethinen Hospital
Linz, Upper Austria, Austria, 4020
2
nemocnice ceske Budejovice
České Budějovice, Czechia, 37087