The United States of America, As Represented by the Secretary, Department of Health and Human Services

Serum Institute of India Private Limited

Ravindra Bapurao Kadam

Baoming Jiang

Roger I Glass

Rajeev Mhalasakant Dhere

Sambhaji Shankar Pisal

Jagdish Kamalaji Zade

Rajendra Narayan Sabale

Roger Glass

Abhijeet Sanjeev Kamble

Stable, immunogenic combination vaccine(s) comprising a mixture of antigens for prevention and prophylaxis of infections caused by Rotavirus, Poliomyelitis virus, Haemophilus influenzae, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis and Hepatitis B virus. A multivalent combination vaccine comprises i) significantly dose-reduced Salk-IPV or Sabin-IPV (IPV) antigens prepared by methods of formaldehyde inactivation and alum hydroxide adsorption resulting in maximum D-antigen recovery; ii) Injectable heat inactivated Rotavirus antigen(s) providing broad cross-protective immunity among human rotavirus strains; iii) Hib PRP-carrier protein conjugate having improved stability and immunogenicity; iv) whole cell pertussis antigen with improved immunogenicity and stability; and v) Homogenous fractions of Diphtheria and Tetanus toxoids. Such stable and immunogenic vaccine compositions are made by i) individually adsorbing dose reduced IPV, IRV antigens on alum hydroxide and keeping other antigen(s) unadsorbed or adsorbed on alum phosphate, alum hydroxide, or a combination thereof; and ii) using an order of addition of antigens during blending.

Multivalent vaccine composition

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Pune Maharashtra, India

Ravindra Bapurao Kadam