TBE prophylaxis
Conditions
Interventions
Trade Name: Encepur Erwachsene
Pharmaceutical Form: Suspension for injection
Other descriptive name: Inactivated TBE virus/strain K23
Concentration unit: µg/ml microgram(s)/millilitre
Concentration ty
Sponsors
Chiron Behring GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Healthy volunteers of both sexes aged >18 who participated in study V48P2E2 and are willing to give informed consent will be included. ·Subjects who are available for the duration of the trial (approximately 3 weeks) ·Subjects who are in good health as determined by medical history, physical examination, and clinical judgment of the investigator Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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 not willing to sign the informed consent form ·Subjects with documented evidence of TBE ·Subjects who receive another vaccine within the 4 weeks before the administration of investigational product and 3 weeks after ·Subjects with acute disease at the day of enrollment (acute disease means moderate or severe illness with or without fever; vaccine can be administered to subjects with minor illness such as mild diarrhea or mild upper respiratory tract infection with body temperature < 38.0°C) ·Subjects with organic brain disturbances, including seizure disorders ·Subjects with progressive neurological disorders ·Subjects who have suffered febrile or afebrile convulsions ·Subjects in whom a general decrease in resistance might be expected, e.g. those who have recently sustained severe injury or undergone recent surgical operations or in whom surgical operations are planned during the study period, are undernourished, or have disorders involving a decreased immune response ·Subjects being treated with immunosuppressants, systemic corticosteroids for longer than 2 months within the past 4 weeks or during the study period, except for topical or inhaled therapy of mild bronchial asthma ·Subjects being treated with immunoglobulins, whole blood or plasma derivates within the last 3 months and during study participation ·Subjects with autoimmune diseases ·Subjects with evidence of hypersensitivity to the investigational product or chemically related substances in their medical history ·Subjects enrolled in other investigational studies at the same time and within the last 3 months ·Subjects with major congenital defects or serious chronic illness (such as insulin dependent diabetes, cancer, autoimmune diseases) as well as any active severe allergic disease ·Subject with any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives ·Woman of childbearing age who refuses to use an effective method of birth control (abstinence, oral or injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent, intrauterine device) beginning 30 days before study entry and continuing through 30 days after the last vaccine dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Descriptive evaluation of the subjects who participated in studies V48P2 (primary immunization), V48P2E1 (first booster immunization) and V48P2E2 (serological follow-up) with respect to antibody titers and percentage of subjects with neutralizing antibodies (NT, in-house, Chiron Vaccines) at 5 years (± 90 days) after the first booster immunization with the new TBE vaccine.;Secondary Objective: To investigate the kinetics of the immune response from Day 0 as defined in protocol V48P2E3 to Day 3, 5, 7, and 21 for study group 2.;Primary end point(s): TBE antibody concentrations as measured by Neutralization Test and ELISA | — |
Countries
Germany
Outcome results
None listed