Evaluation on safety and immunogenicity of tetravalent A/C/W135/Y meningococcal polysaccharide vaccine

ObjectiveTo evaluate the safety and immunogenicity of the tetravalent A/C/W₁₃₅/Y meningococcal poly-saccharide vaccine for subjects at age of 2-30 years.MethodsAdouble blind,randomized,parallel controlled clinical trial was carried out to evaluate side effec trate,positive sero conversion rate and geomatric mean titer(GMT)of the vaccine.ResultsThe side effect rates of the experim entalgroup and the controlgroup were 13.79% and 11.21%;the systemic side effect rates were 5.30% and 6.06% and the local site effect rates were 9.85% and 6.06%,respectively.Seropositive conversion rates of A/C/W₁₃₅/Ysterilizing antibody of the experiment group were more than 94.0% with the GMT values of 1:394.81,1:237.32,1:326.00,and 1:226.45,respectively.Sero positive conversion rates and values of GMT of W₁₃₅ and Ysterilizing antibody between the experimental group and the control group were significantly different.ConclusionThe group A/C/W₁₃₅/Y meningococcal conjug te vaccine has good safety and mimunogenicity for health persons between 2 to 30 years old.