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

NCT ID: NCT00163618

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2006-07-31

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.

Conditions

Encephalitis, Tick-borne

Interventions

Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baxter BioScience Investigator

Role: PRINCIPAL_INVESTIGATOR

Baxter Healthcare Corporation

Locations

Bahnhofstraße 9

Hermagor, , Austria

Freistädter Strasse 290

Linz, , Austria

Conrad-von-Hoetzendorf-Strasse

Voitsberg, , Austria

Grieskirchner Strasse 17

Wels, , Austria

Countries

Austria

Other Identifiers

700501

Identifier Type: -

Identifier Source: org_study_id