The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of an adjuvanted influenza vaccine in elderly subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
G. D'Annunzio University
Chieti, Italy
Office of Hygiene and Public Health, ASL Lanciano
Lanciano, Italy
CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).
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