E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
TBE vaccine (FSME-Immun®) is registered for intra-muscular application. Due to medical reasons (e.g. anticoagulant therapy, adipositas) intra-muscular application is not always possible. The aim of this clinical trial is to investigate whether a comparably good immunogenicity can be achieved via the subcutaneous vaccination route. Thus humoral and cellular immune responses after intramuscular and subcutaneous TBE vaccination in healthy volunteers will be compared. |
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E.1.1.1 | Medical condition in easily understood language |
FSME-Immun® is registered for application into the muscle. This study investigates if application under the skin leads to a comparable immune response.
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
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 |
Humoral immunity, based on TBE Neutralisationtest titer one month +/- 7 days after booster |
Humorale Immunität, basierend auf FSME-Neutralisationstest ein Monat +/- 7 Tage nach Booster |
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E.2.2 | Secondary objectives of the trial |
Cellular immune response, TBE titer course |
Zelluläre Immunantwort, FSME Titerverlauf |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• completed primary TBE immunization + at least one booster immunization
• adults of both sexes between 18 and 60 years of age
• willingness to sign written informed consent form
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E.4 | Principal exclusion criteria |
• age < 18 and > 60 years
• proir TBE infection
• pregnancy and breast feeding
• acute infection on day of inclusion (day 0), (body temperature > 37,9°C)
• concomitant medications: systemic cortison therapy, chemotherapy, immunesuppressive therapy 4 weeks prior to or during study
• administration of other vaccines 4 weeks before/after day 0
• planned surgery within 2 weeks before/after TBE booster vacciantion
• spezific immunotherapy (Hypo-/Desensibilisierung) 14 days before/after vaccination
• any contraindication to adminstration of FSME-Immun® vaccine according to manufacturer's instructions
• history of malignant disease within the last 5 years
• autoimmune diseases
• drug addictions
• plasma donors
• receipt of blood transfusions or immuno globulins within 3 month before study entry |
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E.5 End points |
E.5.1 | Primary end point(s) |
Humoral immunity, based on TBE Neutralisationtest titer |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
One month +/- 7 days after booster |
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E.5.2 | Secondary end point(s) |
Cellular immune response, TBE titer course |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Cellular immune response - evaluated one week after booster vaccination
TBE titer course - titer evaluation before until 6 month after booster vacciantion |
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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 | No |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Immunogenicity one month after vaccination. |
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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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |