Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years
Phase 2
Completed
- Conditions
- Encephalitis, Tick-borne
- Registration Number
- NCT00161746
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Brauhausgasse 1
🇦🇹Mürzzuschlag, Austria
Wiener Strasse 50/2
🇦🇹Kapfenberg, Austria
Fronleichnamsweg 10
🇦🇹Liezen, Austria
Erzherzog Johann Strasse 9
🇦🇹Leoben, Austria
Hauptstrasse 61
🇦🇹Linz, Austria
Conrad-von-Hötzendorf Strasse
🇦🇹Voitsberg, Austria
Grieskirchner Strasse 17
🇦🇹Wels, Austria