NCT00161798CompletedPhase 2
Double-blind, Randomized, Multicenter Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Locations
- 46
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 6 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 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.
- •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.
Investigators
Study Sites (46)
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