Phase 1/2, first-in-human, randomized, double-blind, reference-controlled study to evaluate the safety and immunogenicity of an extemporaneously mixed Combo Inactivated Influenza Vaccine (Green Cross [GC]-IIV; 15µg of each hemagglutinin [HA])/OVX836 (480µg), in comparison to GC-IIV (15µg of each HA) concomitantly administered with OVX836 (480µg), GC-IIV alone (15 µg each HA), OVX836 alone (480µg), and a licensed reference trivalent IIV (Vaxigrip®; 15µg of each HA), administered intramuscularly (IM) in healthy participants

Condition studied

Influenza disease

Investigational medicinal product(s)

Eligibility

Primary endpoint

Number and percentage of participants reporting solicited local and systemic signs and symptoms during seven days after vaccine administration in each group., Number and percentage of participants reporting unsolicited AEs during 28 days after vaccine administration in each group., Occurrence of SAEs during the whole study duration in each group., Occurrence of AESI and/or NOCDs during the whole study duration in each group., Number and percentage of participants with deviations from normal values (judged clinically relevant or not by the Principal Investigator [or Co-Investigators]) of safety laboratory tests during 28 days after vaccine administration, in each group.

Endpoint detail

HAI geometric mean titers (GMTs) on Day 1 (pre-injection baseline), Day 29 and Day 180 for each of the three strains contained in the seasonal vaccines, in each group., Assessment of the CHMP and FDA requirements for seasonal influenza vaccines in each group: Seroconversion rate at Day 29 and Day 180 versus preinjection baseline (Day 1) determined using HAI, for the three influenza strains contained in the GC-IIV and reference licensed IIV (Vaxigrip®)., Assessment of the CHMP and FDA requirements for seasonal influenza vaccines in each group: Proportion of participants achieving a titer ≥1:40 at Day 29 and Day 180 determined using HAI, for the three influenza strains contained in the GC-IIV and reference licensed IIV (Vaxigrip®)., Assessment of the CHMP and FDA requirements for seasonal influenza vaccines in each group: HAI titers Day 29/Day 1 and Day 180/Day 1 geometric mean ratios (GMRs) for the three influenza strains contained in the GC-IIV and reference licensed IIV (Vaxigrip®)., Cell-mediated immune response in terms of change of NPspecific spot-forming unit number in PBMCs upon relevant in vitro stimulation, measured by IFNγ ELISPOT, at Day 8 and Day 29, versus pre-injection baseline (Day 1) in each group., NP-specific CD4+ and CD8+T-cell percentages measured by flow cytometry (on PBMCs), identified as expressing markers such as IL-2, TNFα and/or IFNγ, upon relevant in vitro stimulation at Day 1 (pre-injection baseline), Day 8 and Day 29, in each group., GMTs of anti-NP immunoglobulin G (IgG) (ELISA, serum) at Day 1, Day 29 and Day 180 in each group., Number and percentage of participants with an increase (fourfold) in anti-NP IgG (ELISA, serum) titer on Day 29 and Day 180, with respect to pre-injection baseline (Day 1), in each group., GMTs of anti-OVX313 tag (Oligodom®) IgG level (ELISA, serum) at Day 29 and Day 180 versus pre-injection baseline (Day 1) in each group., Number and percentage of participants reporting ILI episodes and RT-PCR-confirmed influenza Type A or influenza Type B diseases