Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years

Multicentre Randomized Double-Blind Phase II/III Study on the Safety and Immunogenicity of Three Vaccinations With TICOVAC in Two Dosages in Healthy Children Aged Between Six Months and Three Years

The purpose of this study is to evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5 mL, and b) whether there is a difference in terms of safety between the two products.

Inclusion Criteria:

• Male and female children aged between 6 and 47 months
• No history of any previous TBE vaccination
• Clinically healthy
• Informed consent provided by the parents

Exclusion Criteria:

• History of allergic reactions, in particular allergic reactions to one of the components of the vaccine
• Suffering from a disease that cannot be effectively treated or stabilised
• Suffering from a disease or undergoing a form of treatment which can be expected to influence immunological functions
• Suffering from a chronic, degenerative and/or inflammatory disease of the central nervous system
• HIV-positivity (no special HIV test required for the purpose of the study)
• Suffering from a febrile disease
• History of vaccination against yellow fever and/or Japanese encephalitis
• Participation in another clinical trial