Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children

Phase 4

Completed

• Conditions: Encephalitis, Tick-Borne

• Registration Number: NCT00311441
• Lead Sponsor: Novartis

Brief Summary

The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2006-04-03
• Study First Submitted QC: 2006-04-03
• Study First Posted: 2006-04-06
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-14
• Last Update Posted: 2008-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Healthy male and female children, 1 to 10 years of age.

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Exclusion Criteria

• Subjects with documented evidence of TBE
• Subjects, who have been previously vaccinated against TBE

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.

Secondary Outcome Measures

Name	Time	Method
Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever