Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 7 for:    "Encephalitis" | "Pharmaceutical Solutions"

TBE Seropersistence up to 10 Years After First Booster in Adults

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: NCT01582698
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Tracking Information
First Submitted Date  ICMJE April 20, 2012
First Posted Date  ICMJE April 23, 2012
Last Update Posted Date June 24, 2015
Study Start Date  ICMJE April 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
Seropositivity rate measured by neutralization test (NT) 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study [ Time Frame: 118 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2012)
Seropositivity rate measured by neutralization test (NT) 82, 94, 106 and 118 months after the first booster TBE vaccination in the first predecessor study and after the booster vaccination in this study [ Time Frame: 118 months ]
Change History Complete list of historical versions of study NCT01582698 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
  • Seropositivity rate measured by ELISA test 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study [ Time Frame: 118 months ]
  • Antibody titers 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study measured by ELISA and by NT [ Time Frame: 118 months ]
  • Fold increase in antibody concentration after the booster vaccination administered as compared to before the booster vaccination in this study measured by ELISA and by NT [ Time Frame: 118 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2012)
  • Seropositivity rate measured by ELISA test 82, 94, 106 and 118 months after the first booster TBE vaccination in the first predecessor study and after the booster vaccination in this study [ Time Frame: 118 months ]
  • Antibody titers 82, 94, 106 and 118 months after the first booster TBE vaccination in the first predecessor study and after the booster vaccination in this study measured by ELISA and by NT [ Time Frame: 118 months ]
  • Fold increase in antibody concentration after the booster vaccination as compared to before the booster vaccination in this study measured by ELISA and by NT [ Time Frame: 118 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TBE Seropersistence up to 10 Years After First Booster in Adults
Official Title  ICMJE Open-label Phase 4 Study to Investigate the Seropersistence of Tick-borne Encephalitis (TBE) Virus Antibodies From 7 to 10 Years After the First Booster and the Response to a Second Booster Vaccination With FSME-IMMUN 0.5ml in Adults
Brief Summary The purpose of this study is to evaluate TBE antibody persistence from 7 to 10 years after the first booster TBE vaccination with FSME-IMMUN 0.5ml.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Tick-borne Encephalitis (TBE)
Intervention  ICMJE Biological: FSME-IMMUN 0.5 ml
Solution/suspension for injection (intramuscular injection into the deltoid muscle of the right or left upper arm). Dosage frequency of booster vaccination: dependent on serum TBE antibodies.
Study Arms  ICMJE Experimental: Seropersistence evaluation + 2nd booster vaccination
Blood will be drawn to assess the seropersistence of TBE virus antibodies at 82, 94, 106 and 118 months after the first booster vaccination with FSME-IMMUN 0.5ml administered during the first precursor study. Timing of the second booster vaccination will depend on the level of serum TBE antibodies observed during the study. Blood will be drawn 21 - 35 days after vaccination to assess the booster response.
Intervention: Biological: FSME-IMMUN 0.5 ml
Publications * Konior R, Brzostek J, Poellabauer EM, Jiang Q, Harper L, Erber W. Seropersistence of TBE virus antibodies 10 years after first booster vaccination and response to a second booster vaccination with FSME-IMMUN 0.5mL in adults. Vaccine. 2017 Jun 16;35(28):3607-3613. doi: 10.1016/j.vaccine.2017.03.059. Epub 2017 May 22.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2014)
243
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2012)
283
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects who participated in the first and second precursor studies will be eligible for participation in this study if:

  • they understand the nature of the study, agree to its provisions and provide written informed consent
  • they received the first booster vaccination with FSME-IMMUN 0.5ml during the first precursor study and did not receive a second booster vaccination in the second precursor study
  • blood was drawn after their first booster vaccination in the first precursor study

Exclusion Criteria:

Subjects will be excluded from participation in this study if they:

  • received any TBE vaccination since their first booster vaccination with FSME-IMMUN 0.5ml
  • have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster vaccination with FSME-IMMUN 0.5ml
  • are known to be HIV positive since their first booster vaccination with FSME-IMMUN 0.5ml
  • have a known or suspected problem with drug or alcohol abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (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 Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01582698
Other Study ID Numbers  ICMJE 691101
2011-005557-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baxter Healthcare Corporation
Study Sponsor  ICMJE Baxter Healthcare Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eva Maria Poellabauer, MD Baxter Innovations GmbH
PRS Account Baxter Healthcare Corporation
Verification Date June 2015

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