The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Dec. 29, 2020

Filed:

Dec. 13, 2016
Applicant:

Merck Sharp & Dohme Corp., Rahway, NJ (US);

Inventors:

Robert K. Evans, Bangor, MA (US);

Erica L. Strable, Gilbertsville, PA (US);

Lynne Isopi, Sellersville, PA (US);

Assignee:

MERCK SHARP & DOHME CORP., Rahway, NJ (US);

Attorneys:
Primary Examiner:
Assistant Examiner:
Int. Cl.
CPC ...
A61K 39/12 (2006.01); A61P 31/14 (2006.01); A61K 9/00 (2006.01); A61K 39/00 (2006.01);
U.S. Cl.
CPC ...
A61K 39/12 (2013.01); A61K 9/006 (2013.01); A61K 39/0016 (2013.01); A61P 31/14 (2018.01); A61K 2039/5254 (2013.01); A61K 2039/542 (2013.01); A61K 2039/6037 (2013.01); A61K 2039/70 (2013.01); C12N 2720/12334 (2013.01); Y02A 50/30 (2018.01);
Abstract

The present invention relates to thermally stable oral rotavirus vaccine formulations comprising one or more rotavirus reassortant or attenuated rotavirus strains, a pharmaceutically acceptable calcium salt, adipic acid, sucrose, and sodium phosphate, wherein each of the one or more rotavirus reassortant or attenuated rotavirus strain is stable for 7 days at 37° C., for 45 days at 25° C. and for 2 years or more at 2-8° C. The calcium containing formulations of the invention may further comprise one or more excipients which are present in an amount that is effective to optimize the calcium ions free in solution to stabilize the rotavirus particles. In embodiments of the invention, the formulation comprises a surfactant, such as polysorbate 80. The invention also relates to methods of using the rotavirus vaccine compositions of the invention to prevent rotavirus infection, or to reduce the likelihood of infection or to prevent, ameliorate, or delay the onset or progression of the clinical manifestations thereof.


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