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Trial record 32 of 36 for:    "Encephalitis, Tick-Borne"

Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME-IMMUN 0.5 ml in Adults Aged 18 - 67 Years

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ClinicalTrials.gov Identifier: NCT00161785
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 21, 2015
Sponsor:
Information provided by:
Pfizer

Brief Summary:

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 or disease Intervention/treatment Phase
Tick-borne Encephalitis Biological: FSME-IMMUN 0.5ml Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : June 2004
Study Completion Date : July 2005

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Pfizer
Investigators
Principal Investigator: Ryszard Konior, MD Szpital Jana Pawla II Oddzial Neuroinfekcji, Krakow, Poland

ClinicalTrials.gov Identifier: NCT00161785     History of Changes
Other Study ID Numbers: 223
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Tick-Borne Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections