E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Evaluation of Immunogenicity of a TBE (Tick Borne Encephalitis) Vaccine in previously unvaccinated children aged 1 to below 15 years |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
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 |
Evaluate the immunogenicity of FSME-IMMUN 0.25ml Junior administered according to a rapid immunization schedule in children aged 1 to below 15 years. |
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E.2.2 | Secondary objectives of the trial |
Evaluate the safety of FSME-IMMUN 0.25ml Junior administered according to a rapid immunization schedule in children aged 1 to below 15 years. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Subject is ≥ 1 year (from the 1st birthday) to below 15 years (to the last day before the 15h birthday) old at the time of screening; • Subject’s parent(s) / legal guardian(s) provide(s) written informed consent (according to national law); • Subject provides written assent to the study according to age and capacity of understanding; • Subject / parent(s) / guardian(s) understand(s) the nature of the clinical study and is / are willing to comply with the requirements of the protocol (e.g., completion of the Subject Diary, return for follow-up visits); • Subject is generally healthy (i.e. the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical study); • If female of childbearing potential, subject presents with a negative urine pregnancy test within 24 hours prior to the first vaccination and agrees to employ adequate birth control measures for the duration of the study; • Subject is physically and mentally capable of participating in the study. |
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E.4 | Principal exclusion criteria |
• Subject has a history of any previous TBE vaccination or infection; • Subject has a history of infection with other flaviviruses; • Subject has a history of vaccination against Yellow fever and/or Japanese B encephalitis; • Subject has a history of severe allergic reactions, in particular a known sensitivity or allergy to any components of the vaccines; • Subject has a disease (e.g. autoimmune disease) or is undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions; • Subject has received any blood product or immunoglobulins within 90 days prior to study entry; • Subject has a history of testing positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg) or Hepatitis C Virus (HCV). No confirmatory testing for previous infection with these viruses will be conducted as part of this study; • Subject has a functional or surgical asplenia; • Subject has a rash, dermatologic condition or tattoos which might interfere with injection site reaction rating; • Subject or one of subject’s parent(s) / 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 personnel conducting the study. • If female, subject is pregnant or lactating at the time of study enrollment. • Subject has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or device during the course of this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• 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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 15 |