E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
assess the immunogenicity, safety and interchangeability of two tick-borne encephalitis (TBE) vaccines in children aged 1-11 years |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10043847 |
E.1.2 | Term | Tick-borne viral encephalitis |
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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 objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years with the first and second vaccination with either FSME-IMMUN 0.25 ml or Encepur 0.25 ml children and the third vaccination FSME-IMMUN 0.25 ml only, administered according the conventional schedule (0, 28 and 360 days). Primary Endpoint Immunogenicity: Seropositivity rate as determined by neutralization test (NT) 28 days after the second vaccination. |
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E.2.2 | Secondary objectives of the trial |
Immunogenicity: Seropositivity rate determined by NT 180 days after the 1st vaccination and 28 days after the 3rd vacciantion. Seropositivity rate determined by ELISA and antibody response measured by NT and Elisa 28 days after the 2nd vaccination and 180 days after the 1st vaccination and 28 days after the 3rd vaccination. Fold increase of antibody response measured by NT and ELISA 28 days after the 2nd vaccination and 180 days after the 1st vaccination and 28 days after the 3rd vaccination as compared to baseline. Safety: Frequency and severity of injection site reactions occuring after each vaccination. Frequency and severity of systemic reactions occuring after each vaccination. Frequency and severity of adverse experiences (AEs) observed during the entire follow-up period for each study group. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
they are aged > 1 years (from the first birthday) to 11 years (to the last day before the 12 th birthday) their parents/legal guardians provide written informed consent children provide written assent to the study according to age and capacity of understanding their parents/guardians understand the nature of the clincial trial ans will comply with the requirements of the protocol (e.g. completion of the subject diary, return for follow-up visits) are generelly healthy, (i.e the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical trial) show a negative pregnancy test result at the first medical examination (if the subject is a female and capable of bearing children) |
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E.4 | Principal exclusion criteria |
they have a history of any previous TBE vaccination they have a history of TBE infection they have a history of infection with other flaviviruses they have a history of vaccination against yellow fever and/or Japanese B-encephalitis they have a history of severe allergic reactions, in particular a known sensitivity or allergy to any components of the vaccines they suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions they have received any blood product or immunoglobulin within 90 days prior to study entry they are known to be HIV positive (an HIV test is not required specifically for the purpose of this study) they have a functional or surgical asplenia they have a rash or other dermatological condition at the injection site which could interfere with injection site reaction evaluation they were administered an investigational product within six weeks prior to study start or are concurrently participating in another clinical study that includes the administration of an investigational product they are pregant or breastfeeding (if a femal subject) they or their parents/legal guardian(s) are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e children or grandchildren, partner/spouse, siblings) as well as employees of the investigator or site conducting the study. Subjects who suffer from an acute illness with or without elevated body temperature (≥37.5°C) within 3 days prior to the scheduled first vaccination will not be vaccinated until their body temperature returns to normal. In this case the first vacciantion will be given at a separate visit at a later date, so long as the center is still open for recruitment. If subjects have received antipyretics within 4 hours prior to the scheduled time of vaccination, the vaccination should be performed at a later date, so long as the center is still open for recruitment. Subjects who received any live vaccine within 4 weeks or any inactivated vaccine within 2 weeks prior to the scheduled first study vaccination will not be vaccinated until an interval of 4 or 2 weeks, respectively, has passed, provided the center is still open for recruitment. If a subject had a tick bite within 4 weeks before the scheduled first or second vaccination, the vaccination shall be postponed until an interval of 4 weeks has passed. Subjects who are determined to have previously been exposed to the TBE virus (as demonstrated by ELISA IMMUNOZYM: > 126 VIE U/ml or ELISA ENZYGNOST: >10.32 U/ml, and/or NT ≥ 1:10 at baseline) will be included in the study, but will be excluded for the assessment of immunogenicity. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity: Seropositivity rate as determined by neutralization test (NT) 28 days after the second vaccination |
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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 | 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 | No |
E.8.1.3 | Single blind | Yes |
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) | Yes |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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 | 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 | |
E.8.9.1 | In the Member State concerned months | 16 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 16 |