E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Thick-Borne Encephalitis |
Tekenencephalitis |
|
E.1.1.1 | Medical condition in easily understood language |
Thick-Borne Encephalitis (TBE) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
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 |
To estimate the time to seroconversion of the different schedules of accelerated TBE vaccination based on reactogenicity data up to 28 days after the first dose. |
|
E.2.2 | Secondary objectives of the trial |
1. To estimate the proportion of subjects with neutralizing antibodies (≥ 10) at day 7, day 14, day 21, day 28, month 3 and month 6 after the start of primary vaccination for the 5 different vaccination regimens.
2. To estimate the proportion of subjects with neutralizing antibodies (≥ 10) after completion of the primary vaccination schedule (1 year after the first dose)) for the 5 different vaccination regimens.
3. Occurrence of solicited local and general symptoms within 7 days after each vaccination.
4. Occurrence of AEs for 7 days after each vaccination.
5. Occurrence of SAEs for 14 days after each vaccination. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. ≥18 to ≤60 years of age at time of inclusion
2. Willingness to provide written informed consent
3. Personnel members at the Belgian Defense
4. Prepared to follow the study schedule |
|
E.4 | Principal exclusion criteria |
1. Seropositive for TBE (tested during screening visit).
2. Subjects with a known allergy to one of the components of the vaccine
3. Immune depressed subjects or subjects who take immunodepressant and/or –stimulant medication
4. Planned land deployment to TBE endemic regions during the study period
5. Ongoing pregnancy or active child wish (for female subjects)
6. Planned vaccination with an inactivated vaccine within 2 weeks before or after each vaccination or with a live attenuated vaccines within 1 month before or after each vaccination
7. Yellow fever vaccination planned within the whole study period |
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E.5 End points |
E.5.1 | Primary end point(s) |
Seroconversion is defined as neutralizing antibodies ≥ 10 based on the plaque reduction neutralization test (PRNT). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Neutralizing antibodies as measured with PRNT.
2. Occurrence of solicited local and general symptoms, AEs and SAEs |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 7, day 14, day 21, day 28, month 3, month 6 and year 1 |
|
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 | No |
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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Group 1 using the classic accelerated schedule of adose of 0,5 ml at day 0 and at day 14 |
|
E.8.2.4 | Number of treatment arms in the trial | 5 |
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.8.5 | 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 | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |