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

NCT00890422 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2009-04-29

No results posted yet for this study

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.

Conditions

  • Tick Borne Encephalitis

Interventions

BIOLOGICAL

FSME vaccination (FSME-Immun)

intra muscular 0.5 ml

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • ASOKLIF

    collaborator UNKNOWN

  • Elisabethinen Hospital

    lead OTHER

Principal Investigators

  • Helmut Mittermayer · Elisabethinen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-11-30
Completion
2010-07-31

Countries

  • Austria
  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00890422 on ClinicalTrials.gov