Tick-borne Encephalitis
Conditions
Brief summary
The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.
Interventions
BIOLOGICALFSME-IMMUN NEW 0.25 ml
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 15 Years
Inclusion criteria
Male and female children and adolescents will be eligible for participation in this study if: * they are aged 1 year (from the 1st birthday) to \< 16 years (to the last day before the 16th birthday); * they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial); * their parents/legal guardians understand the nature of the study and agree to its provisions; * written informed consent is available from both parents/legal guardians, * for Germany/Austria: additional written informed consent is available for children older than 8 years * they or their parents/legal guardians agree to keep a volunteer diary. For safety reasons, female volunteers who have reached sexual maturity at study start have to meet the following additional inclusion criteria: \- negative pregnancy test at study entry;
Exclusion criteria
Children and adolescents will be excluded from participation in this study if they: * have a history of any TBE vaccination; * have a history of TBE infection; * have a history of allergic reactions to one of the components of the vaccine; * suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions; * are known to be HIV positive (a special HIV test is not required for the purpose of the study); * have received banked blood or immunoglobulins within one month of study entry; * have a history of vaccination against yellow fever and/or Japanese B-encephalitis; * suffer from hemorrhagic diathesis; * are participating simultaneously in another clinical trial; * if female: are pregnant or breastfeeding. Volunteers who meet the inclusion/
Countries
Austria, Germany, Poland
Outcome results
None listed