Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Conditions:
Encephalitis, Tick-borne
Eligibility:
All Genders
7-11 years
Brief 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 receive...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
OBSERVATIONAL
End Date :
July 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00163618
Start Date
June 1 2005
End Date
July 1 2006
Last Update
May 21 2015
Active Locations (4)
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1
Bahnhofstraße 9
Hermagor, Austria, 9620
2
Freistädter Strasse 290
Linz, Austria, 4040
3
Conrad-von-Hoetzendorf-Strasse
Voitsberg, Austria, 8570
4
Grieskirchner Strasse 17
Wels, Austria, 4600