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Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.

Last updated on March 14, 2019

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Study Location
Grieskirchner Strasse 17
Wels, , 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
1-5 year
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Male and female children will be eligible for participation in this study if:

- they are 1 year (from the 1st birthday) to 6 years (to the last day before the 6th
birthday) old;

- they are clinically healthy;

- their legal representative understands the nature of the study, agrees to its
provisions and gives written informed consent;

- their legal representative agrees to keep a Volunteer Diary.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Children will be excluded from participation in this study if they:

- have a history of any previous TBE vaccination;

- have a history of TBE infection or show evidence of a latent TBE infection (as
demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10);

- have a history of allergic reactions, in particular to one of the components of the
vaccine;

- have received antipyretics within 4 hours prior to the first TBE vaccination;

- suffer from a disease that cannot be effectively treated or stabilized;

- suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment
that can be expected to influence immunological functions;

- suffer from chronic, degenerative and / or inflammatory disease of the central nervous
system;

- are known to be HIV positive (a special HIV test is not required for the purpose of
the study);

- suffer from a febrile illness at study entry;

- have a history of vaccination against yellow fever and / or Japanese B-encephalitis;

- are participating simultaneously in another clinical trial.

NCT00161772
Pfizer
Completed
Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.

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[email protected]

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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