Status:
COMPLETED
Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.
Lead Sponsor:
Pfizer
Conditions:
Tick-borne Encephalitis
Eligibility:
All Genders
6-15 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 will be investigated in healthy children aged 6 to 16 years.
Eligibility Criteria
Inclusion
- Male and female children will be eligible for participation in this study if:
- they are 6 years (from the 6th birthday) to 16 years old (to the last day before the 16th birthday);
- they are clinically healthy;
- their legal representative - and if older than 8 years the volunteer - understands the nature of the study, agrees to its provisions and gives written informed consent;
- their legal representative agrees to keep a Volunteer Diary.
- For safety reasons female volunteers capable of bearing children have to fulfill the following inclusion criteria at study start:
- negative pregnancy test at study start;
- they agree to employ adequate birth control measures for the duration of the study.
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.
- if female, are pregnant or breast feeding
- Volunteers who meet the inclusion / exclusion criteria, but have a febrile illness (body temperature \>= 38° C, measured orally) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
End Date :
March 1 2002
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00161798
Start Date
September 1 2001
End Date
March 1 2002
Last Update
May 21 2015
Active Locations (23)
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1
Neuschwansteinstrasse 5
Augsburg, Germany, 86163
2
Marktplatz 33
Bad Saulgau, Germany, 88348
3
Hauptstrasse 9
Bietigheim-Bissingen, Germany, 74321
4
Salzgasse 11
Calw, Germany, 75365