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, with adaptive design in terms of number of subjects vaccinated and influenza seasons followed-up. 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.
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 18-55 years.