E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
TBE antibody concentrations as measured by Neutralization Test and ELISA |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |