Provided are a pneumococcal conjugate combined vaccine and a preparation method therefor. The combination comprises 26 different pneumococcal
polysaccharide-
protein conjugates, and the pneumococcal
polysaccharide comprises a total of 26 serotypes, i.e., 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 24F, 33F and 35B. The
carrier protein used by the conjugate is
tetanus toxoid (TT). The
polysaccharide is covalently linked to the TT by means of a cyano
activation method so as to prepare a polysaccharide-
protein conjugate
stock solution, and the polysaccharide-
protein conjugate
stock solution is then adsorbed by an aluminum
adjuvant in an appropriate proportion so as to obtain the
pneumococcal conjugate vaccine. The pneumococcal polysaccharide used therein requires no
degradation reaction, effectively protecting the
antigenicity of the polysaccharide. Three consecutive batches of production of the conjugate
stock solution and vaccine are performed, and the yield and each
verification index of the conjugate are stable. The results of non-
clinical safety evaluation research show that the vaccine has good safety and
immunogenicity. The prepared
pneumococcal conjugate vaccine is used for immunoprophylaxis of pneumococcal infection of relevant serotypes.