Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT00163618
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
11 Years
Study:
NCT00163618
Study Brief:
Protocol Section:
NCT00163618