Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults

Phase 4

Completed

• Conditions: Encephalitis, Tick-Borne

• Registration Number: NCT00311493
• Lead Sponsor: Novartis

Brief Summary

The purpose of this study it is to evalutate the persistence of antibodies after a booster immunisation with a TBE vaccine for adults

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-04-03
• Study First Submitted QC: 2006-04-03
• Study First Posted: 2006-04-06
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-12
• Last Update Posted: 2007-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

• Healthy volunteers of both sexes aged >18 who participated in another study on TBE vaccination

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Exclusion Criteria

• Subjects with any condition, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.

Secondary Outcome Measures

Name	Time	Method
Booster response in a subset of subjects as measured by NT, ELISA and cellular immunity on Days 3, 5, 7 and 21 after 2nd booster immunization.