This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route. Primary Objective: To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years. Secondary Objective: To evaluate the safety profile during the 21-day period following each vaccination in each study group
This is an open (for the administration route) and double-blind (only for the two dosages administered at year 0 by using the investigational administration route) randomized trial conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections at 1-year interval.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,150
0.1 mL, ID. 1 injection/year for 3 years
0.1 mL, ID. 1 injection/year for 3 years.
0.5 mL, IM. 1 injection/year for 3 years
Unnamed facility
Gribomont, Belgium
Unnamed facility
Kraainem, Belgium
Unnamed facility
Linkebeek, Belgium
Unnamed facility
Molenbeek, Belgium
Unnamed facility
Thuin, Belgium
Unnamed facility
Hradec Králové, Czechia
Unnamed facility
Kaunas, Lithuania
Unnamed facility
Vilnius, Lithuania
To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine.
Time frame: 21days post-vaccination
To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine
Time frame: 21 days post-vaccination and entire study duration
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