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

Pfizer

Status and phase

Completed

Phase 3

Phase 2

Conditions

Encephalitis, Tick-borne

Treatments

Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00161746

146A

Details and patient eligibility

About

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.

Sex

All

Ages

6 to 47 months old

Volunteers

Accepts Healthy Volunteers

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