Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster … (NCT00163618) | Clinical Trial Compass
CompletedNot Applicable
Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children
AustriaStarted 2005-06
Plain-language summary
The objective of this study is to assess the TBE antibody persistence approximately three years after administration of a TBE booster vaccination with FSME-IMMUN 0.25 ml Junior in children who received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series in Study 146A.
Who can participate
Age range7 Years – 11 Years
SexALL
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Inclusion Criteria:
* Male and female children who participated in Study 146A if:
* 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 child (according to age and capacity of understanding) and the parents/legal guardians
* they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study 146A
* they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A
Exclusion Criteria:
* Subjects who received any further TBE vaccination since their first TBE booster vaccination
* Subjects with a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study 146A
* Subjects who have suffered from a disease (e.g. autoimmune disease) or have undergone a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination
* Subjects who have been known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study 146A
* Subjects who have received a blood transfusion or immunoglobulins within 30 days of study entry