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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Page 1 of 1 (4 locations)

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

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 | DecenTrialz