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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Brief Title

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


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.
    


Study Phase

Phase 4

Study Type

Interventional




Condition

Tick-borne Encephalitis

Intervention

FSME-IMMUN 0.5ml


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

340

Start Date

June 2004

Completion Date

July 2005


Eligibility 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.
      

Gender

All

Ages

18 Years - 67 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Ryszard Konior, MD, , 

Location Countries

Poland

Location Countries

Poland

Administrative Informations


NCT ID

NCT00161785

Organization ID

223



Study Sponsor

Pfizer


Study Sponsor

Ryszard Konior, MD, Principal Investigator, Szpital Jana Pawla II Oddzial Neuroinfekcji, Krakow, Poland


Verification Date

May 2015