Tick-borne Encephalitis
Conditions
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.
Interventions
BIOLOGICALTick-borne Encephalitis Vaccine
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
Yes
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.
Countries
Austria, Germany
Outcome results
None listed