EUCTR2007-000810-35-CZ
Active, not recruiting
Phase 1
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
BIOVOMED0 sites300 target enrollmentMarch 27, 2007
ConditionsPrevention 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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- BIOVOMED
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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