Status:
COMPLETED
Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.
Lead Sponsor:
Pfizer
Conditions:
Tick-borne Encephalitis
Eligibility:
All Genders
1-5 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2002
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00161772
Start Date
March 1 2002
End Date
August 1 2002
Last Update
May 21 2015
Active Locations (23)
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1
Grieskirchner Strasse 17
Wels, Austria, 4600
2
Neuschwansteinstrasse 5
Augsburg, Germany, 86163
3
Marktplatz 3
Bad Saulgau, Germany, 88348
4
Hauptstrasse 9
Bietigheim-Bissingen, Germany, 74321