E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
No medical condition, healthy volunteers will be recruited.
(In this study the status of antibody titers against tick borne encephalitis will be investigated in healthy subjects who have received their primary vaccination in a parent trial in 2006.)
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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 |
The purpose of this study is to evaluate whether the first booster interval after primary vaccination with Encepur agains Tick borne encephalitis can be prolonged from 3 years (current SPC recommendation) to 5 years.
Primary objectives:
1. To determine the proportion of study subjects with a TBE neutralizing titer ≥ 10 at 3, 4 and 5 years after completion of the primary immunization.
2. The kinetics of the response over time (at years 3, then 4, then 5) will also be assessed.
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E.2.2 | Secondary objectives of the trial |
1. To determine the proportion of study subjects with detectable TBE neutralizing antibody response (i.e. NT ≥ 2, the detection limit of the neutralizing assay) at 3, 4 and 5 years after completion of the primary immunization within each group.
2. Descriptive evaluation of levels of TBE-specific binding antibodies as measured by a commercial, validated ELISA (Enzygnost®, Dade Behring) at 3, 4 and 5 years after completion of the primary immunization within each group.
3. Comparative evaluation of antibody responses (NT and ELISA) in subjects having received the first 2 injection with FSME-Immun® Junior vs those having received first 2 injections with Encepur® Children at 3, 4 and 5 years after completion of the primary immunization.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy M48P3 study subjects with parental or legal guardian informed consent (health status as determined by review of medical history and physical examination and in the clinical judgment of the investigator)
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E.4 | Principal exclusion criteria |
•Subjects who did not receive complete schedule of primary vaccination in M48P3. •Subjects enrolled in other investigational studies at the same time and within the last three months •Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives |
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E.5 End points |
E.5.1 | Primary end point(s) |
≥ 85% of study subjects achieve NT titers ≥ 10 (within each group, according to the diffent groups of parent trial) |
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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 | 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 | No |
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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.1.7.1 | Other trial design description |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
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 | 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
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As defined in the protocol: The end of the trial will be after all available subjects have completed the third blood draw, 2 years after the first blood draw, provided that: primary end point is met after the first year, and after the second year. If the primary endmoint is not met at the interim analyses, the trial will not be continued.
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |