This Phase 2a clinical study is designed to evaluate the immunogenicity and the safety of one dose of OVX836 influenza vaccine administered IM, confirm the dose level and regimen, and expand immunogenicity and safety data to adults through age 65.
This is a Phase 2a, randomised, double-blind study in 300 adults to compare the safety and immunogenicity of OVX836 to QIV (Influvac TetraTM). One dose of OVX836 at two dose levels will be administered intramuscularly, in comparison to Influvac TetraTM, quadrivalent seasonal influenza sub-unit vaccine in healthy subjects aged 18-65 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
300
One single administration intramuscularly at Day 1.
One single administration intramuscularly at Day 1.
Centre for Vaccinology (CEVAC)
Ghent, Belgium
NP-specific IFNγ T-cell increase measured by ELISPOT at Day 8 versus pre-injection baseline (Day 1) in the pooled age strata
Time frame: at Day 8 versus pre-injection baseline (Day 1)
Proportion of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic symptoms (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever) using an electronic Diary
Time frame: during 7 days after vaccine administration
Proportion of subjects reporting unsolicited Adverse Events
Time frame: during 28 days after vaccine administration
Proportion of subjects with Influenza-Like-Illness cases associated with laboratory-confirmed influenza
Time frame: during the whole study duration, 180 days
Severity scores of Influenza-Like-Illness cases (as per Flu-PRO® questionnaire)
Time frame: during the whole study duration, 180 days
Proportion of subjects reporting Serious Adverse Events
Time frame: during the whole study duration, 180 days
NP-specific IFNγ T-cell activity measured by ELISPOT in the pooled age strata and by age stratum (18-49 years; 50-65 years)
Time frame: at Day 8, Day 29 and Day 180 versus pre-injection baseline (Day 1)
NP T-cell phenotype and functionality by flow cytometry in the pooled age strata and by age stratum (18-49 years; 50-65 years)
Time frame: at pre-injection baseline (Day 1), Day 8, Day 29 and Day 180
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Anti-NP Immunoglobulin G (IgG) titers by ELISA at each time point in the pooled age strata and by age stratum (18-49 years; 50-65 years)
Time frame: at pre-injection baseline (Day 1), Day 8, Day 29 and Day 180