Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults

Phase 4

Completed

• Conditions: Tick Born Encephalitis

• Registration Number: NCT00387634
• Lead Sponsor: Novartis Vaccines

Brief Summary

evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-11
• Study First Submitted QC: 2006-10-11
• Study First Posted: 2006-10-13
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-01
• Last Update Posted: 2012-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

Inclusion Criteria

• healthy subjects who have completed study V48P7

Exclusion Criteria

• acute illness at day of immunization
• general decrease in resistance
• progressive neurological disorders
• history of febrile or afebrile convulsions
• major congenital defects
• serious chronic illness
• hypersensitivity to study vaccine
• treatment with immunosuppressants or systemic corticosteroids, immunoglobulins, whole blood or plasma derivates

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA	On day 21, year 1, year 2, year 3, year 4, year 5

Secondary Outcome Measures

Name	Time	Method
safety of TBE vaccine for adults with respect to local and systemic reactions and adverse event reporting	Local and systemic reactions: up to Day 3 post vaccination; Adverse events: 21 days post vaccination; SAEs: throughout the study