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

Completed

• Conditions: Encephalitis, Tick-borne

• Registration Number: NCT00163618
• Lead Sponsor: Pfizer

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 received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series in Study 146A.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-14
• Study Completion: 2006-07
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Freistädter Strasse 290; 🇦🇹 Linz, Austria

Bahnhofstraße 9; 🇦🇹 Hermagor, Austria

Conrad-von-Hoetzendorf-Strasse; 🇦🇹 Voitsberg, Austria

Grieskirchner Strasse 17; 🇦🇹 Wels, Austria