Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.
Phase 2
Completed
- Conditions
- Tick-borne Encephalitis
- Registration Number
- NCT00161772
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine in healthy children aged 1 to 6 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Male and female children will be eligible for participation in this study if:
- they are 1 year (from the 1st birthday) to 6 years (to the last day before the 6th birthday) old;
- they are clinically healthy;
- their legal representative understands the nature of the study, agrees to its provisions and gives written informed consent;
- their legal representative agrees to keep a Volunteer Diary.
Exclusion Criteria
Children will be excluded from participation in this study if they:
- have a history of any previous TBE vaccination;
- have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10);
- have a history of allergic reactions, in particular to one of the components of the vaccine;
- have received antipyretics within 4 hours prior to the first TBE vaccination;
- suffer from a disease that cannot be effectively treated or stabilized;
- suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions;
- suffer from chronic, degenerative and / or inflammatory disease of the central nervous system;
- are known to be HIV positive (a special HIV test is not required for the purpose of the study);
- suffer from a febrile illness at study entry;
- have a history of vaccination against yellow fever and / or Japanese B-encephalitis;
- are participating simultaneously in another clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Grieskirchner Strasse 17
🇦🇹Wels, Austria
Neuschwansteinstrasse 5
🇩🇪Augsburg, Germany
Marktplatz 3
🇩🇪Bad Saulgau, Germany
Hauptstrasse 9
🇩🇪Bietigheim-Bissingen, Germany
Salzgasse 11
🇩🇪Calw, Germany
Mohrenstrasse 8
🇩🇪Coburg, Germany
Bahnhofstrasse 1
🇩🇪Elzach, Germany
Rheinstrasse 13
🇩🇪Ettenheim, Germany
Peter-Seifert-Strasse 5
🇩🇪Gersfeld, Germany
Solothurner Strasse 2
🇩🇪Heilbronn, Germany
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