Glaxosmithkline Biologicals Sa

Smithkline Beecham Biologicals S.a.

Vincent Vande Velde

Brigitte Desiree Alberte Colau

Annick Poliszczak

Francoise Denamur

Isabelle Knott

Georges Thiry

The invention provides liquid rotavirus formulations that are suitable for oral administration to human infants. In particular the invention provides pharmaceutical compositions and vaccines, comprising a rotavirus antigen, a sugar and a carboxylate wherein said formulation has a pH of between pH 5.0 and pH 8.0 and comprises no phosphate or less than 5 mM phosphate. The invention also provides methods of preparing said rotavirus formulations and use thereof in the prevention or treatment of rotavirus associated diseases in humans.

Live attenuated rotavirus vaccine for oral administration

This invention provides liquid rotavirus formulations that are suitable for oral administration to human infants. In particular, the invention provides pharmaceutical compositions and vaccines, comprising a rotavirus antigen, a sugar and a carboxylate, wherein said formulation has a pH of between pH 5.0 and pH 8.0 and comprises no phosphate or less than 5 mM phosphate. The invention also provides methods of preparing said rotavirus formulations and use thereof in the prevention or treatment or rotavirus associated diseases in humans.

The invention provides an attenuated rotavirus population comprising a single variant or substantially a single variant which is defined by a nucleotide sequence encoding at least one of the major viral proteins designated as VP4 and VP7. The invention particularly provides a rotavirus population designated as P43. The invention further provides a novel formulation for a rotavirus vaccine which is in the form of a quick dissolving tablet for immediate dissolution when placed on the tongue.

Homogeneous attenuated human rotavirus population

Immunogenic composition of a homogeneous live attenuated human rotavirus population

Vaccine

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New York, NY, United States of America

Vincent Vande Velde