Oil-in-water emulsion influenza vaccine
AssigneeGlaxosmithkline Biologicals SA
InventorsWilliam Ripley BALLOU, Emmanuel Jules HANON
Life of this patent
Estimating the term…
Abstract
The present invention provides an immunogenic influenza composition in a dose volume suitable for human use, comprising an influenza virus antigen or antigenic preparation thereof and an adjuvant composition comprising an oil-in-water emulsion, wherein said oil-in-water emulsion comprises a metabolisable oil at a level of below 11 mg and an emulsifying agent at a level of below 5 mg and optionally a tocol or a sterol at a level of below 12 mg. Suitably the amount of influenza antigen per strain per dose is 15 μg HA or a low amount such as less than 15 μg HA.
Claims19
-60. (canceled)
A method for the preparation of an immunogenic composition in a dose volume suitable for human use,
- wherein the immunogenic composition comprises an aqueous suspension that comprises an influenza virus antigen or antigenic preparation prepared in the presence of less than or equal to 5 μg/ml thiomersal;
- wherein the influenza virus antigen or antigenic preparation comprises 0.5 to 7 μg of haemagglutinin (HA) per dose per influenza strain;
- wherein the immunogenic composition comprises an oil-in-water emulsion adjuvant that consists of an aqueous carrier, squalene and one or two emulsifying agents, and wherein the squalene is present in an amount from 0.5 mg to 9 mg and the one or two emulsifying agents are present in a total amount from 0.1 mg to 5 mg per human dose;
- the method comprising admixing a first volume of the oil-in-water emulsion adjuvant and a second volume of the aqueous suspension, wherein the first volume is greater than the second volume, and wherein the dose volume is between 0.25 ml and 1.5 ml.
Dependencies are inferred from the claim text.