To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in children.
This is an open, uncontrolled study to assess safety and tolerability of Fluval P monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children of 6-36 months of age. The vaccination is not repeated. Tolerability and safety (incidence of adverse events) of the study drug is assessed after Day 28 then after Day 180-210 following the vaccination.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
10
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. Dose: 0.25 ml (total 3 μg HA), single dose.
"Csolnoky Ferenc" Veszprém County Hospital
Veszprém, Veszprém megye, Hungary
Incidence of adverse events
To assess tolerability/safety (incidence of adverse events) of the study drug after Day 28 following the vaccination.
Time frame: 28 days after vaccination
Incidence of adverse events
To assess safety of the study drug after Day 180-210 following the vaccination.
Time frame: 180-210 days after vaccination
Efficacy of the study drug
To assess the efficacy of the study drug by epidemiological follow-up of the participants until Day 180-210 following the vaccination.
Time frame: 180-210 days after vaccination
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