3 Clinical Trials for Various Conditions
The study is a prospective single site exploratory study to examine the impact of Food and Drug Administration (FDA) approved seasonal flu vaccine on the immune responses of H5N1 vaccine previously received with or without the AS03 adjuvant.
The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pandemic influenza. The vaccine, identified as H5-VLP + GLA-AF, consists of a recombinant influenza virus H5 protein (hemagglutinin from A/Indonesia/5/2005) produced in a plant-based expression system assembling into virus-like particles together with the adjuvant GLA-AF.
The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies. The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.