TBE prophylaxis MedDRA version: 8.1 Level: LLT Classification code 10043847 Term: Tick-borne viral encephalitis
Conditions
Interventions
Trade Name: ENCEPUR PRO DOSPELÉ
Pharmaceutical Form: Suspension for injection
Sponsors
Novartis Vaccines and Diagnostics GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - healthy subjects who/whose parents/legal representative signed informed consent prior to study entry - subjects who have completed study V48P7 - 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? yes 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - subjects with acute disease at the day of booster immunization (acute disease means moderate or severe illness with or without fever. All vaccines can be administered to subjects with minor illness such as mild diarrhea or mild upper respiratory tract infection with oral temperature < 38.0°C.)* - subjects in whom a general decrease in resistance might be expected, e.g. those who have recently sustained major injury or undergone recent major surgical operations, are undernourished, or have disorders involving a decreased immune response - subjects: a) with organic brain disturbances, including seizure disorders* b) with progressive neurological disorders c) who have suffered febrile or afebrile convulsions* d) with major congenital defects e) with serious chronic illness (such as insulin dependent diabetes, cancer, autoimmune diseases) f) with evidence of hypersensitivity to the study vaccine or chemically related substances in their medical history* - subjects being treated with: a) immunosuppressants or systemic corticosteroids within the past 4 weeks or during the study period, except short term use of topic corticosteroids b) immunoglobulins, whole blood or plasma derivates up to 3 months before enrollment - subjects who have received another vaccine within 4 weeks before the administration of the study vaccine * - subjects enrolled in another investigational, clinical study at the same time or within the last 3 months - women who are pregnant (in case of uncertainty, pregnancy should be excluded by a pregnancy test) * - women of childbearing age who refuse 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 28 days before study entry and continuing through 28 days after the immunization* * Only apply to subjects receiving booster immunization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Descriptive evaluation of subjects with respect to antibody titers and percentage of subjects with neutralizing antibodies on Day 0 (i.e., day of first booster immunization after primary immunization in study V48P7 for subjects who did not get a booster immunization, or day of first blood draw for those who did receive a booster dose), on Day 21 (+7 days) and Year 1, 2, 3, 4, and 5 (± 30 days each) after booster immunization with Novartis Vaccines' (ex Chiron’s) TBE vaccine for adults as measured by Neutralization Test (NT, in-house, Novartis Vaccines). Subjects who have already received a booster immunization before this study, will only provide blood samples on Day 0 and Year 1, 2, 3, 4, and 5 (± 30 days each) thereafter;Secondary Objective: Descriptive evaluation of subjects with respect to antibody concentrations and percentage of subjects with antibodies on Day 0 (i.e., day of first booster immunization after primary immunization in study V48P7), on Day 21 (+7 days) and Year 1, 2, 3, 4, and 5 (± 30 days each) after first booster immunization with Novartis Vaccines' (ex Chiron’s) TBE vaccine for adults as measured by ELISA, including avidity determination as determined by ELISA for selected time points (Enzygnost®, Dade Behring). Subjects who have already received a booster before this study, will only provide blood samples on Day 0 and Year 1, 2, 3, 4, and 5 (± 30 days each) thereafter. Evaluation of tolerability and safety of a single dose of Novartis Vaccines' (ex Chiron's) TBE vaccine for adults (using selected local and systemic reactions and adverse event reporting) when given as first booster immunization 3 years after the last dose of the primary immunization.;Primary end point(s): TBE antibody levels in serum on Days 0, Day 21 (except for subjects not receiving a booster within the study), Year 1, 2, 3, 4 and 5 as measured by NT (in-house, Novartis Vaccines) and ELISA (Enzygnost®, Dade Behring), including avidity determination as determ | — |
Countries
Czech Republic
Outcome results
None listed