Tick Born Encephalitis Clinical Trial
Official title:
A Phase IV, Uncontrolled, Open-label, Single-center Study in Adolescents and Adults: Evaluation of Immunogenicity and Safety of the First Booster Immunization With Novartis' TBE Vaccine for Adults in Participants of Study V48P7 and Long-term Evaluation of Immunogenicity up to 5 Years After First Booster Immunization
| Verified date | November 2012 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Czech Republic: State Institute for Drug Control |
| Study type | Interventional |
evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster
| Status | Completed |
| Enrollment | 323 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 15 Years to 68 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Vaccines |
Czech Republic,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | 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 | Yes |