Open Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Rapid Immunization Schedule with FSME-IMMUN 0.25 ml JUNIOR in Healthy Children aged 3 - 15 Years

Phase 1

• Conditions: Prevention of Tick-born encephalitis (TBE). The rapid immunization schedule recommended in the current SPC for FSME-IMMUN 0.5 ml (Day 0, Day 14) has been used in Austria for 20 years. FSME-IMMUN 0.25 ml was first administered in clinical trials in the year 2001 and the rapid immunization schedule is recommended for children ranging 1 to 16 years of age. However, limited data on immunogenicity when using the rapid immunization schedule in children exist.; MedDRA version: 9.1Level: LLTClassification code 10043847Term: Tick-borne viral encephalitis

• Registration Number: EUCTR2007-000810-35-CZ
• Lead Sponsor: BIOVOMED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-27
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

- the written informed consent of their parents / legal guardians
- with their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits)
- aged > 3 years (from the 3rd birthday) to < 15 years (to the last day before the 16th birthday);
- clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN 0.25 ml JUNIOR outside the scope of a clinical trial);
- negative pregnancy test result at the first medical examination (if female and capable of bearing children);

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- history of any previous TBE vaccination;
- history of TBE infection or other flaviviruses;
- history of vaccination against yellow fever and/or Japanese B-encephalitis;
- history of allergic reactions, in particular to one of the components of the vaccine;
- suffering 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;
- blood transfusion or immunoglobulins within one month of study entry;
- known HIV positivity (an HIV test is not required)
- simultaneously participation in another clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified