Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine (immunisation)
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ClinicalTrials.gov Identifier: NCT00890422 |
Recruitment Status : Unknown
Verified April 2009 by Elisabethinen Hospital.
Recruitment status was: Active, not recruiting
First Posted : April 29, 2009
Last Update Posted : April 29, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tick Borne Encephalitis | Biological: FSME vaccination (FSME-Immun) | Phase 2 |
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 injection 4 days later (immunisation schedule 1). Another one-third will receive 2 injections in all: one on the first day and one injection 4 days later (immunisation schedule 2). The remaining one-third will also receive 2 injections, both of these on the first day (immunisation schedule 3). Participants will be assigned completely randomly (by chance) to one of these three groups. So each participant stands a 33% chance (a 1:2 chance) of receiving any one particular immunisation schedule. If you agree to take part, the process will be as follows:
Brief Overview of the Course of the Clinical Study:
Vaccination scheme 1
Vaccination scheme 2
Vaccination scheme 3
Vaccinations:
I = Vaccination with FSME-IMMUN 0,5ml
- Scheme 1: 2 vaccinations at U1 (day 0), one injection into the left and the right upper arm each, 1 vaccination at U2 (day 4), injection into the left upper arm
- Scheme 2: one vaccination at U1 (day 0) and at U2 (day 4), injections into the left upper arm each
- Scheme 3: 2 vaccinations at U1 (day 0), one injection into the left and the right upper arm each
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 99 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Clinical Study to Test the Immunogenicity of Variant Schedules for TBE Rapid Immunisation Using Inactivated TBE (FSME) Vaccine |
Study Start Date : | March 2007 |
Estimated Primary Completion Date : | November 2009 |
Estimated Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 1FSME vaccination
2 vaccination on day 0
|
Biological: FSME vaccination (FSME-Immun)
intra muscular 0.5 ml
Other Name: FSME-Immun 0.5 ml |
Experimental: 2 FSME vaccination
1 vaccination on day 0 and one vaccination on day 4
|
Biological: FSME vaccination (FSME-Immun)
intra muscular 0.5 ml
Other Name: FSME-Immun 0.5 ml |
Experimental: 3 FSME vaccination
2 vaccinations on day 0 and 1 vaccination on day 4
|
Biological: FSME vaccination (FSME-Immun)
intra muscular 0.5 ml
Other Name: FSME-Immun 0.5 ml |
- 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 [ Time Frame: U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56) ]
- FSME antibody level at U2, U3, U4, U5, U6, U7, U8 and U9 [ Time Frame: U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- age not 19 or over 65
- pregnancy
- risk of becoming pregnant

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): NCT00890422
Austria | |
Elisabethinen Hospital | |
Linz, upper Austria, Austria, 4020 | |
Czech Republic | |
nemocnice ceske Budejovice | |
Ceske Budejovice, Czech Republic, 37087 |
Principal Investigator: | Helmut Mittermayer | Elisabethinen Hospital |
Responsible Party: | Helmut Mittermayer/Univ.Prof. Dr., Elisabethinen Hospital |
ClinicalTrials.gov Identifier: | NCT00890422 |
Other Study ID Numbers: |
ASOKLIF 0608/MI Eudract number: 2006-006955-10 |
First Posted: | April 29, 2009 Key Record Dates |
Last Update Posted: | April 29, 2009 |
Last Verified: | April 2009 |
encephalitis FSME central european encephalitis |
Encephalitis, Tick-Borne Encephalitis Central Nervous System Diseases Encephalitis, Arbovirus Encephalitis, Viral Central Nervous System Viral Diseases Central Nervous System Infections Infectious Encephalitis Tick-Borne Diseases |
Brain Diseases Nervous System Diseases Infections Arbovirus Infections Vector Borne Diseases Virus Diseases RNA Virus Infections Flavivirus Infections Flaviviridae Infections |