Multicenter Phase IV 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

Pfizer4 sites in 1 countryJune 2005

ConditionsEncephalitis, Tick-borne

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Encephalitis, Tick-borne
Sponsor: Pfizer
Locations: 4
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

July 2006

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

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