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Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine

NCT ID: NCT00890422

Last Updated: 2009-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Tick Borne Encephalitis

Keywords

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encephalitis FSME central european encephalitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1FSME vaccination

2 vaccination on day 0

Group Type EXPERIMENTAL

FSME vaccination (FSME-Immun)

Intervention Type BIOLOGICAL

intra muscular 0.5 ml

2 FSME vaccination

1 vaccination on day 0 and one vaccination on day 4

Group Type EXPERIMENTAL

FSME vaccination (FSME-Immun)

Intervention Type BIOLOGICAL

intra muscular 0.5 ml

3 FSME vaccination

2 vaccinations on day 0 and 1 vaccination on day 4

Group Type EXPERIMENTAL

FSME vaccination (FSME-Immun)

Intervention Type BIOLOGICAL

intra muscular 0.5 ml

Interventions

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FSME vaccination (FSME-Immun)

intra muscular 0.5 ml

Intervention Type BIOLOGICAL

Other Intervention Names

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FSME-Immun 0.5 ml

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

ASOKLIF

UNKNOWN

Sponsor Role collaborator

Elisabethinen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elisabethinen Hospital

Principal Investigators

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Helmut Mittermayer

Role: PRINCIPAL_INVESTIGATOR

Elisabethinen Hospital

Locations

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Elisabethinen Hospital

Linz, Upper Austria, Austria

Site Status

nemocnice ceske Budejovice

České Budějovice, , Czechia

Site Status

Countries

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Austria Czechia

Related Links

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http://www.elisabethinen.or.at

ethics committee of the Elisabethinen hospital

Other Identifiers

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Eudract number: 2006-006955-10

Identifier Type: -

Identifier Source: secondary_id

ASOKLIF 0608/MI

Identifier Type: -

Identifier Source: org_study_id