The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regime of Inflexal V in unprimed children aged 6 - \<36 months, using the EMA guideline for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as reference.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
205
vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart
Inflexal V 0.5 mL administrated once only
Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital
Milan, Italy
Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena"
Milan, Italy
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Seroprotection rate
Time frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Seroconversion rate
Time frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
Time frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability
Time frame: Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary
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