Influenza Clinical Trial
Official title:
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 18-55 Years
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.
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. ;
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