Immunogenic composition
The present application discloses an immunogenic composition comprising a Hib saccharide conjugate, at least one additional bacterial, for example N. meningitidis , saccharide conjugate(s), and a further antigen selected from the group consisting of whole cell pertussis and hepatitis B surface antigen, wherein the saccharide dose of the Hib saccharide conjugate is less than 5 μg.
1. A process for making an immunogenic composition, said immunogenic composition comprising:
a Haemophilus influenza type b (Hib) saccharide conjugate;
an N. meningitidis capsular saccharide conjugate derived from a strain selected from the group consisting of serogroups A, B, C, W135 and Y;
whole cell pertussis; and
hepatitis B surface antigen;
the method comprising;
mixing the Hib saccharide conjugate with at least one N meningitidis capsular saccharide conjugate and with the whole cell pertussis and hepatitis B surface antigen to form a composition wherein the saccharide dose of the Hib saccharide conjugate is less than 5 ug and the saccharide does of the N. meningitidis capsular saccharide conjugate is less than 8 μg, and wherein the Geometric Mean Concentration (GMC) for whole cell pertussis or hepatitis B achieved with said immunogenic composition is higher than the GSM achieved after immunisation with said immunogenic composition containing a 5 μg saccharide dose of Hib saccharide conjugate and a 8 μg dose of a N. meningitidis capsular saccharide conjugate.