The present study will evaluate the efficacy, immunogenicity and safety of one dose of OVX836 influenza vaccine 480μg, after intramuscular administration in healthy subjects aged 18-59 years.
This Phase 2b proof-of-concept field efficacy study is designed as a randomized, double-blind, parallel groups, placebo-controlled, multi-country, multicenter clinical trial. This design of prospective interventional trial is the gold standard in evaluating absolute efficacy of a product in preventing a disease or an outcome. An adequate number of observations is ensured by the multicenter approach.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,850
One single administration intramuscularly at Day 1.
One single administration intramuscularly at Day 1.
Site BE-02
Antwerp, Belgium
Site BE-03
Antwerp, Belgium
Site BE-01
Ghent, Belgium
First occurrence of RT-PCR-confirmed influenza Type A symptomatic disease
Time frame: During the whole study duration, up to maximum 10 months
First occurrence of RT-PCR-confirmed influenza symptomatic disease irrespective of strain/type.
Time frame: During the whole study duration, up to maximum 10 months.
First of occurrence of RT-PCR-confirmed influenza Type B symptomatic disease
Time frame: During the whole study duration, up to maximum 10 months
Number of subtype of virus in RT-PCR-confirmed influenza Type A cases.
Time frame: During the whole study duration, up to maximum 10 months
Severity and duration of Influenza Like Illness episodes
Time frame: During the whole study duration, up to maximum 10 months
First occurence of clinical influenza-like disease irrespective of causal agent
Time frame: During the whole study duration, up to maximum 10 months
Number of occurence of solicited local and systemic signs and symptoms
Time frame: During 7 days after vaccine administration
Number of occurence of subjects reporting unsolicited AEs
Time frame: During 29 days after vaccine administration
Number of occurence of subjects reporting Serious Adverse Events, Adverse Events of Special Interest, New Onset of Chronic Disease, Medical Attended Adverse Events
Time frame: During the whole study period, maximum 10 months
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Site BE-04
Mechelen, Belgium
Site FI-12
Espoo, Finland
Site FI-08
Helsinki, Finland
Site FI-13
Jarvenpaa, Finland
FI-14
Kokkola, Finland
Site FI-11
Oulu, Finland
Site FI-15
Seinäjoki, Finland
...and 6 more locations
Cell-mediated immune response in Peripheral Blood Mononuclear Cells, measured by Interferon Gamma Enzyme-Linked Immunospot Assay in a limited subset of 56 subjects.
Elispot
Time frame: At Day 1 and Day 8
Number and percentage of subjects with NP-specific T-cell measured by Interferon Gamma Enzyme-Linked Immunospot Assay.
Elispot
Time frame: At Day 1 and Day 8
Percentage of NP specific CD4+ and CD8+ T-cell measured by flow cytometry on PBMCs as expressing IL-2, TNFα and/or IFNγ at pre-injection baseline (Day 1)
ICS
Time frame: At Day 1 and Day 8
Number and percentage of subjects with a percentage of NP specific CD4+ and CD8+ T-cell expressing IL-2, TNFα and/or IFNγ at Day 8 or Day 29 higher than the percentile 95 of the pre-injection baseline (Day 1)
ICS
Time frame: At Day 1 and Day 8
Geometric Mean Titer of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum).
Elisa
Time frame: At Day 1 and Day 8
Number and percentage of subjects with a four-fold increase of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum) titre with respect to pre-injection baseline (Day 1)
Elisa
Time frame: At Day 1 and Day 8
Percentage of NP specific CD4+ and CD8+ T-cell measured by flow cytometry on PBMCs as expressing IL-2, TNFα and/or IFNγ in a limited subset of 56 subjects
ICS
Time frame: At Day 1 and Day 8
Anti-Nucleoprotein immunoglobulin G measured by Enzyme-Linked Immunosorbent Assay in, serum in a limited subset of 56 subjects.
Elisa
Time frame: At Day 1 and Day 8