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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Elisabethinen Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Baxter Healthcare Corporation
ASOKLIF
Information provided by:
Elisabethinen Hospital
ClinicalTrials.gov Identifier:
NCT00890422
First received: April 28, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted

April 28, 2009
April 28, 2009
March 2007
November 2009   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine
Clinical Study to Test the Immunogenicity of Variant Schedules for TBE Rapid Immunisation Using Inactivated TBE (FSME) Vaccine

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.

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Tick Borne Encephalitis
Biological: FSME vaccination (FSME-Immun)
intra muscular 0.5 ml
Other Name: FSME-Immun 0.5 ml
  • Experimental: 1FSME vaccination
    2 vaccination on day 0
    Intervention: Biological: FSME vaccination (FSME-Immun)
  • Experimental: 2 FSME vaccination
    1 vaccination on day 0 and one vaccination on day 4
    Intervention: Biological: FSME vaccination (FSME-Immun)
  • Experimental: 3 FSME vaccination
    2 vaccinations on day 0 and 1 vaccination on day 4
    Intervention: Biological: FSME vaccination (FSME-Immun)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
99
July 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
19 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic
 
NCT00890422
ASOKLIF 0608/MI, Eudract number: 2006-006955-10
No
Helmut Mittermayer/Univ.Prof. Dr., Elisabethinen Hospital
Elisabethinen Hospital
  • Baxter Healthcare Corporation
  • ASOKLIF
Principal Investigator: Helmut Mittermayer Elisabethinen Hospital
Elisabethinen Hospital
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP