TBE prophylaxis
Conditions
Interventions
Trade Name: Encepur®Kinder
Pharmaceutical Form: Suspension for injection
Other descriptive name: Inactivated TBE virus / strain K23
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type
Sponsors
Chiron Behring GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: male and female children - who and whose parents/legal guardians are willing to sign the informed consent - who are 1 to 10 years of age at the time of first vaccination - who are available for the duration of the trial - who are in good health as determined by medical history, physical examination, and clinical judgement of the investigator Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - subjects who have been passively immunizedwith TBE immunglobulin in the 3 months before the start of the trial - subjects with documented evidence of TBE - subjects already vaccinated against TBE or yellow fever - subjects who receive another vaccine within the 4 weeks before or after each administration of study vaccine - acute disease at day of enrolment - organic brain disturbances, including seizure disorder - progressie neurological disorders - subjects who have suffered febrile or afebrile convulsions - subjects in whom a general decrease in resistance might be expected - treatment with immunosuppressants, systemic corticosteroids for longer than 2 months within the past 4 weeks or during the study period, except for topical use or inhaled therapy of mild bronchial asthma - treatment with immunoglobulin, whole blood or plasma derivates during the last 6 months before the trial - autoimmune diseases - evidence of hypersensitivity to the study medication or chemically related substances - subjects enrolled in another investigational trial at the same time and within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluation of the immunogenicity of two pediatric TBE vacines, in terms of antibody titers and percentages of subjects with neutralizing antibodies >= 10 or >= 2 at (42 (+12) days after first TBE immunization when using two different immunization schedules, as measured by neutralization test evaluation of tolerability and safety of two pediatric TBE vaccines when using two different immunization schedules;Secondary Objective: not applicable;Primary end point(s): - body temperature after first vaccination - TBE antibody titers as measured by Neutralization Test and ELISA | — |
Countries
Germany
Outcome results
None listed