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TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)

NCT00161967 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2015-05-21

No results posted yet for this study

Summary

The purpose of this study is to assess the seropersistence of TBE antibodies in children and adolescents aged 1 to 15 years at the time of their first vaccination, 24 months and 34 months after completion of primary immunization with FSME-IMMUN 0.25 ml (3 vaccinations during the predecessor study 209), as well as the immune response to a booster vaccination with FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml administered 36 months after the third vaccination (in Study 209).

Protocol amendment of October 2006: The study has been prolonged for children and adolescents who still showed highly positive TBE virus antibody concentrations at approximately 3 years after the third vaccination and therefore did not receive a booster vaccination at this time point. Further follow-up of TBE antibody persistence is now included for these subjects at 46 and 58 months after the third vaccination (in Study 209), as well as a booster vaccination offered at either 48 or 60 months after the third vaccination (in Study 209), depending on individual TBE antibody levels.

Conditions

  • Encephalitis, Tick-Borne

Interventions

BIOLOGICAL

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Subjects receive one vaccination with either FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml, depending on their age.

Sponsors & Collaborators

Principal Investigators

  • Baxter BioScience Investigator · Baxter BioScience

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2008-07-31
Completion
2008-11-30

Countries

  • Austria
  • Germany
  • Poland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00161967 on ClinicalTrials.gov