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
- Interventions
- Biological: TBE vaccine for adults
- 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
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
- Arm && Interventions
Group Intervention Description Arm 1 TBE vaccine for adults Blood draw only, no vaccine Arm 2 TBE vaccine for adults Blood draw only, no vaccine Arm 3 TBE vaccine for adults Blood draw only, no vaccine Arm 4 TBE vaccine for adults Blood draw only, no vaccine
- 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