To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
Via Dei Vestini, Chieti, Italy
Ufficio Igiene e Sanità Pubblica di Lanciano, Via S. Spaventa, 37
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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