- authorisedPhase I and Phase II (Integrated)- First administration to humans
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
This clinical trial is testing a new combination flu jab in healthy adults aged 18 and over. Researchers want to see if combining a standard seasonal flu vaccine with a new investigational vaccine is safe and helps the body produce a strong immune defence against influenza over six months.
Belgium - recruitingTherapeutic exploratory (Phase II)
Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to 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 study is testing a new flu vaccine called OVX836 in healthy adults aged 18 to 59. We want to see how well it prevents the flu, if it's safe, and how the body reacts to it after just one shot. It's a careful study comparing the vaccine to a dummy treatment.
France · Finland · Belgium