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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

Last updated on November 9, 2019

FOR MORE INFORMATION
Study Location
Hospital in Debica - Zespo Opieki Zdrowotnej w Debicy
Debica, , 33-200 Poland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tick-borne Encephalitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-67 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00161785
Pfizer
Completed
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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Descriptive Information
Brief Title  ICMJE Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME-IMMUN 0.5 ml in Adults Aged 18 - 67 Years
Official Title  ICMJE Not Provided
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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Tick-borne Encephalitis
Intervention  ICMJE Biological: FSME-IMMUN 0.5ml
Study Arms  ICMJE Not Provided
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 Completed
Enrollment  ICMJE
 (submitted: October 19, 2006)
340
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE July 2005
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 67 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 Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00161785
Other Study ID Numbers  ICMJE 223
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator:Ryszard Konior, MDSzpital Jana Pawla II Oddzial Neuroinfekcji, Krakow, Poland
PRS AccountPfizer
Verification DateMay 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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