Immunogenic composition

Abstract

The present application discloses an immunogenic composition comprising at least 2 different N. meningitidis capsular saccharides, wherein one or more is/are selected from a first group consisting of MenA, MenC, MenY and MenW which is/are conjugated through a linker to a carrier protein(s), and one or more different saccharides is/are selected from a second group consisting of MenA, MenC, MenY and MenW which is/are directly conjugated to a carrier protein(s).

1 .- 106 . (canceled) 
     
     
         107 . An immunogenic composition, comprising:
 (a) a  Neisseria meningitidis  ( N. meningitids ) serogroup A capsular saccharide conjugated to an adipic acid dihydrazide (ADH) linker, wherein the linker is conjugated to tetanus toxoid carrier protein;   (b) a  N. meningitidis  serogroup C capsular saccharide conjugated to an adipic acid dihydrazide (ADH) linker, wherein the linker is conjugated to tetanus toxoid carrier protein;   (c) a  N. meningitidis  serogroup W capsular saccharide directly conjugated to tetanus toxoid carrier protein in the absence of a linker; and   (d) a  N. meningitidis  serogroup Y capsular saccharide directly conjugated to tetanus toxoid carrier protein in the absence of a linker;   wherein each  N. meningitidis  capsular saccharide is present at a dose of 5 μg.   
     
     
         108 . The immunogenic composition of  claim 107 , wherein the ratio of Men W and/or Y saccharide to carrier protein is between 1:0.5 and 1:2 (w/w). 
     
     
         109 . The immunogenic composition of  claim 107 , wherein the composition does not include an adjuvant. 
     
     
         110 . The immunogenic composition of  claim 107 , wherein the composition does not include an aluminum salt adjuvant. 
     
     
         111 . The immunogenic composition of  claim 107 , further comprising sucrose. 
     
     
         112 . The immunogenic composition of  claim 107 , further comprising a  N. meningitidis  serogroup B outer membrane vesicle preparation or capsular saccharide. 
     
     
         113 . The immunogenic composition of  claim 107 , further comprising  Haemophilus  influenza ( H. influenzae ) b capsular saccharide conjugated to a carrier protein, the carrier protein selected from the group consisting of tetanus toxoid, diphtheria toxoid, cross reactive material 197, fragment C of tetanus toxoid and protein D, wherein the  H. influenzae  b conjugate is present in a lower dose than the dose of any other bacterial saccharide conjugate. 
     
     
         114 . The immunogenic composition of  claim 113 , wherein the  H. influenzae  b capsular saccharide (Hib) is conjugated to tetanus toxoid. 
     
     
         115 . A pharmaceutical composition, comprising the immunogenic composition of  claim 107  and a pharmaceutically acceptable excipient. 
     
     
         116 . A process of making a vaccine comprising the step of mixing the immunogenic composition of  claim 107  with a pharmaceutically acceptable excipient. 
     
     
         117 . A method of immunizing a human host against disease caused by  Neisseria meningitidis  infection, comprising administering to the host an immunoprotective dose of the immunogenic composition of  claim 107 .