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TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)

Last updated on March 11, 2019

FOR MORE INFORMATION
Study Location
Grieskirchner Strasse 17
Wels, Upper Austria, 4600 Austria
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
3-18 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Participated in Baxter study 209 and:

- They and/or their parents / legal guardians understand the nature of the study and
agree to its provisions

- Written informed consent is available from the parents / legal guardians according to
national law

- Written informed assent is available from the child/adolescent according to age and
capacity of understanding

- They received the third vaccination with FSME-IMMUN 0.25 ml during the course of
Baxter study 209

- Blood was drawn after their third vaccination during the course of Baxter study 209

- They showed an ELISA concentration > 126 VIE U/ml and / or a NT titer >=10 after the
third vaccination in Baxter study 209

- They or their parents / legal guardians agree to keep a Subject Diary

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Received any TBE vaccination since their third vaccination with FSME-IMMUN 0.25 ml

- Have a history of infection with or vaccination against other flaviviruses (Dengue
fever, yellow fever and / or Japanese B-encephalitis virus) since their third
vaccination with FSME-IMMUN 0.25 ml

- 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 0.25 ml

- Received a blood transfusion or immunoglobulins within 30 days of the first and second
blood draw (as applicable)

- Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week
or equivalent level of other alcoholic beverages)

- 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

- Are not clinically healthy, (i.e. the physician would have reservations vaccinating
with a TBE vaccine outside the scope of a clinical trial)

- 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

- Have shown an allergic reaction to one of the components of the vaccine since their
third vaccination in Baxter study 209

- Have donated blood or plasma within 30 days of the booster vaccination if female of
childbearing potential - are pregnant or breastfeeding before the booster vaccination
(positive pregnancy test result at the medical examination before the booster
vaccination)

- 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 received any vaccination within 4 weeks prior to the booster vaccination will
not be vaccinated until an interval of four weeks has passed.

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

Females of childbearing potential will only be vaccinated if they agree to employ adequate
birth control measures from 4 weeks before the booster vaccination until the end of the
study.

NCT00161967
Pfizer
Completed
TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)

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Pfizer Clinical Trials Contact Center

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[email protected]

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