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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Baxter Healthcare Corporation
ASOKLIF
Information provided by:
Elisabethinen Hospital

Tracking Information
First Submitted Date  ICMJE April 28, 2009
First Posted Date  ICMJE April 29, 2009
Last Update Posted Date April 29, 2009
Study Start Date  ICMJE March 2007
Estimated Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine
Official Title  ICMJE Clinical Study to Test the Immunogenicity of Variant Schedules for TBE Rapid Immunisation Using Inactivated TBE (FSME) Vaccine
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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Tick Borne Encephalitis
Intervention  ICMJE Biological: FSME vaccination (FSME-Immun)
intra muscular 0.5 ml
Other Name: FSME-Immun 0.5 ml
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 28, 2009)
99
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2010
Estimated Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00890422
Other Study ID Numbers  ICMJE ASOKLIF 0608/MI
Eudract number: 2006-006955-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Helmut Mittermayer/Univ.Prof. Dr., Elisabethinen Hospital
Study Sponsor  ICMJE Elisabethinen Hospital
Collaborators  ICMJE
  • Baxter Healthcare Corporation
  • ASOKLIF
Investigators  ICMJE
Principal Investigator: Helmut Mittermayer Elisabethinen Hospital
PRS Account Elisabethinen Hospital
Verification Date April 2009

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