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Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME-IMMUN 0.5 ml in Adults Aged 18 - 67 Years
This study has been completed.
Sponsored by: Baxter Healthcare Corporation
Information provided by: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00161785
  Purpose

The purpose of this study is to assess:

  • TBE antibody persistence 2 and 3 years after the third TBE vaccination with FSME-IMMUN 0.5ml by means of ELISA and neutralization test (NT).
  • TBE antibody response to a booster vaccination with FSME-IMMUN 0.5ml, by means of ELISA and NT.

Condition Intervention Phase
Tick-Borne Encephalitis
Biological: FSME-IMMUN 0.5ml
Phase IV

MedlinePlus related topics: Encephalitis
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Baxter Healthcare Corporation:

Estimated Enrollment: 340
Study Start Date: June 2004
Estimated Study Completion Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Male and female subjects 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 third vaccination with FSME-IMMUN 0.5ml during the course of Baxter Study 213;
  • blood was drawn before and after their third vaccination during the course of Baxter Study 213;
  • they showed an ELISA-concentration > 126 VIE U/ml and / or a NT-titer >= 1:10 after the third vaccination in Baxter Study 213;
  • they agree to keep a Subject Diary.

Exclusion Criteria:

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

  • received any TBE vaccination since their third vaccination with FSME-IMMUN 0.5ml;
  • received a vaccination against yellow fever and / or Japanese B-encephalitis since their third vaccination with FSME-IMMUN 0.5ml;
  • are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination with FSME-IMMUN 0.5ml;
  • have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages);
  • have received a blood transfusion or immunoglobulins within one month to the first and second blood draw;
  • have participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies).

Subjects will not be eligible for booster vaccination if:

  • they do not meet the inclusion/exclusion criteria;
  • they are not clinically healthy, (i.e. the physician would have reservations vaccinating with FSME-IMMUN 0.5ml outside the scope of a clinical trial);
  • they suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
  • they have donated blood or plasma within one month to the booster vaccination;
  • female of childbearing potential are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination);
  • they have shown an allergic reaction to one of the components of the vaccine since their third vaccination in Baxter Study 213;
  • they are simultaneously participating in another clinical trial including administration of an investigational product within six weeks prior to the booster vaccination until the end of the study.

Subjects who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature >= 38.0°C, measured orally) at the scheduled time of vaccination, will not be vaccinated until their body temperature returns to normal.

Subjects who have received any vaccination within two weeks prior to the booster vaccination will not be vaccinated until an interval of two weeks has passed.

If subjects have received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161785

Locations
Poland
Hospital in Debica - Zespo Opieki Zdrowotnej w Debicy
Debica, Poland, 33-200
Szpital Jana Pawla II Oddzial Neuroinfekcji
Krakow, Poland, 31-202
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Ryszard Konior, MD Szpital Jana Pawla II Oddzial Neuroinfekcji, Krakow, Poland
  More Information

Study ID Numbers: 223
Study First Received: September 8, 2005
Last Updated: October 19, 2006
ClinicalTrials.gov Identifier: NCT00161785  
Health Authority: Poland: Ministry of Health

Study placed in the following topic categories:
Virus Diseases
Tick-borne encephalitis
Antibodies
Central Nervous System Infections
Central Nervous System Diseases
Arbovirus Infections
Brain Diseases
Tick-Borne Diseases
Encephalitis
Immunoglobulins
Encephalitis, Tick-Borne

Additional relevant MeSH terms:
Encephalitis, Viral
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
Central Nervous System Viral Diseases
Encephalitis, Arbovirus

ClinicalTrials.gov processed this record on January 16, 2009