摘要目的 评价3～7岁儿童同时接种23价肺炎球菌多糖疫苗(PPV23)和流感病毒裂解疫苗(TIV)的免疫原性和安全性.方法 招募3～7岁健康儿童,随机分为3组,分别接种PPV23(PPV23组)、TIV(TIV组)以及同时接种PPV23和TIV(联合组),并随访1年.结果 本研究共招募1035人,其中PPV23组327人,TIV组348人,联合组360人.联合组的7种肺炎球菌血清型几何平均浓度(GMC)与PPV23组相比差异均无统计学意义(P>0.05).联合组的3种流感病毒血清型与TIV组相比,联合组的甲3型血清阳转率较高(88.75％vs.84.20％,P=0.01),但乙型的血清阳转率较低(92.84％vs.98.56％,P<0.001).观察期内3组的一级不良反应差异无统计学意义(P=0.197);联合组的二级不良反应发生率为3.61％,高于其他两组(均P<0.001).所有不良反应均在对症治疗后痊愈,无三级及以上严重不良反应发生.结论 联合组的PPV23和TIV均具有良好的免疫原性和安全性,可以同时接种,推荐作为预防易感儿童季节性流感和肺炎球菌感染的免疫策略.

abstractsObjective To evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine ( PPV23) and trivalent influenza vaccine ( TIV) in pre-schoolers. Methods A total of 1035 children aged 3-7 years were enrolled in this study and randomly di-vided into three groups, inoculated PPV23, TIV and both, respectively. A one-year follow-up study was conducted for immunogenicity and safety analysis. Results A total of 1035 serological specimens were col-lected, including 327 in PPV23 group, 348 in TIV group and 360 in concomitant vaccination group. No sig-nificant differences in geometric mean concentrations (GMC) of seven pneumococcal serotypes were observed between the PPV23 group and the concomitant vaccination group. Compared with the TIV group, the con-comitant vaccination group showed higher serological conversion rate of H3 type (88. 75％ vs 84. 20％ , P=0. 01), but lower serological conversion rate of B type (92. 84％ vs 98. 56％ , P<0. 001). There was no significant difference in the primary adverse reactions between the three groups (P = 0. 197). The rate of secondary adverse reactions occurred in the concomitant vaccination group was 3. 61％ , which was higher than that of the other two groups (both P<0. 001). All adverse reactions were mild or moderate, and cured after treatment. Conclusions Concomitant immunization with PPV23 and TIV is safe and have good immu-nogenicity, thus a viable immune strategy for susceptible children.