Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine
immunisation
Clinical Study to Test the Immunogenicity of Variant Schedules for TBE Rapid Immunisation Using Inactivated TBE (FSME) Vaccine
2 other identifiers
interventional
99
2 countries
2
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 investigators will test the immunogenicity (the degree of immunity achieved) of each of the immunisation schedules at various times after the injections. If the results of this clinical study are positive, it may then be possible to develop the most successful immunisation schedule so that it can be used routinely. This means that the results of the clinical study have an enormous practical value in preventing TBE in people travelling or moving into areas with a high TBE risk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2007
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 28, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedApril 29, 2009
April 1, 2009
2.7 years
April 28, 2009
April 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
achievement of FSME-Antibody-level (IgG) >25IU/ml at visit U2, U3, U4, U5, U6, U7, U8 and U9-yes/no achievement of FSME antibody-level (IgG) of >126VIEU/ml at U2, U3;U4, U5, U6, U7, U8 and U9-yes/no
U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56)
Secondary Outcomes (1)
FSME antibody level at U2, U3, U4, U5, U6, U7, U8 and U9
U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56)
Study Arms (3)
1FSME vaccination
EXPERIMENTAL2 vaccination on day 0
2 FSME vaccination
EXPERIMENTAL1 vaccination on day 0 and one vaccination on day 4
3 FSME vaccination
EXPERIMENTAL2 vaccinations on day 0 and 1 vaccination on day 4
Interventions
intra muscular 0.5 ml
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- age not 19 or over 65
- pregnancy
- risk of becoming pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elisabethinen Hospitallead
- Baxter Healthcare Corporationcollaborator
- ASOKLIFcollaborator
Study Sites (2)
Elisabethinen Hospital
Linz, Upper Austria, 4020, Austria
nemocnice ceske Budejovice
České Budějovice, 37087, Czechia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helmut Mittermayer
Elisabethinen Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 28, 2009
First Posted
April 29, 2009
Study Start
March 1, 2007
Primary Completion
November 1, 2009
Study Completion
July 1, 2010
Last Updated
April 29, 2009
Record last verified: 2009-04