Objective: To investigate the safety of the tetravalent meningococcal conjugate vaccine (MPCV-ACYW) in combination with the inactivated poliomyelitis (IPV) vaccine and diphtheria-tetanus-acellular pertussis (DTaP) vaccine for infants aged 3-5 months and provide real-world evidence for the immunization strategy of vaccine combination. Methods: From June to October 2023, a total of 600 3-month-old infants were selected and divided into three groups: control group, mono-vaccination group and combined vaccination group. They were simultaneously or individually vaccinated with MPCV-ACYW, IPV and DTaP vaccines at 3, 4, and 5 months of age, respectively. The incidence rate of adverse reactions within 30 days after each dose was observed. Results: All 600 infants completed at least one vaccination and entered the safety data analysis. The age of the control group (100 infants), the mono-vaccination group (250 infants), and the combination group (250 infants) was (101.20±7.88), (102.26±7.94), and (102.35±7.76) days, respectively. The body lengths were (63.00±3.02), (62.55±3.06), and (63.14±4.02) cm, respectively. The body weights were (6.90±0.77), (6.86±0.94), and (6.99±0.95) kg, respectively. Boys accounted for 49%, 50.4%, and 52.4%, respectively, with no statistically significant differences (all P>0.05). The overall incidence rates of adverse reactions in the control group, mono-vaccination group, and combined vaccination group were 4.00%, 2.80%, and 3.20%, respectively, with systemic adverse reaction rates of 3.00%, 2.40%, and 2.00%. The incidence rates of local adverse reactions were 1.00%, 0.40%, and 1.20%, with no statistically significant differences (all P>0.05). Adverse reactions were mainly grade 1, with incidence rates of grade 1 adverse reactions of 3.00%, 2.00%, and 1.60% in the three groups, and incidence rates of grade 2 adverse reactions of 1.00%, 0.80%, and 1.60%, respectively. No grade 3 or 4 serious adverse reactions occurred, and the differences were not statistically significant (all P>0.05). The adverse reaction symptoms of the three groups were mainly systemic reactions, among which fever and diarrhea symptoms were reported in individual cases in each group, with no statistically significant differences in the incidence rate (all P>0.05). The symptoms of adverse reactions were mostly transient and self-relieved, all of which were cured. Conclusion: The combination of MPCV-ACYW and IPV or DTaP vaccines is safe for infants aged 3-5 months.
目的： 探讨3~5月龄婴儿四价流脑结合疫苗（MPCV-ACYW）与灭活脊髓灰质炎（IPV）疫苗、百白破（DTaP）疫苗联合接种的安全性，为疫苗联合接种免疫策略提供现实世界依据。 方法： 2023年6月~10月选取600名3月龄婴儿，分为对照组、单独接种组和联合接种组3组，分别在3、4、5月龄同时或单独接种MPCV-ACYW、IPV和DTaP疫苗，观察每剂接种后30 d内的不良反应发生情况。 结果： 600名研究对象均完成至少1次接种，均进入安全性数据分析。对照组（100名）、单独接种组（250名）和联合组（250名）的年龄分别为（101.20±7.88）、（102.26±7.94）、（102.35±7.76）d；身长分别为（63.00±3.02）、（62.55±3.06）、（63.14±4.02）cm；体重分别为（6.90±0.77）、（6.86±0.94）、（6.99±0.95）kg；男童分别占49%、50.4%和52.4%，差异均无统计学意义（均P>0.05）。对照组、单独接种组和联合接种组总体不良反应发生率分别为4.00%、2.80%和3.20%，其中全身不良反应发生率为3.00%、2.40%和2.00%；局部不良反应发生率为1.00%、0.40%和1.20%，差异均无统计学意义（均P>0.05）。不良反应以1级为主，三组中1级不良反应发生率分别为3.00%、2.00%和1.60%，2级不良反应发生率分别为1.00%、0.80%和1.60%，未发生3级、4级严重不良反应，差异均无统计学意义（均P>0.05）。3组的不良反应症状均以全身反应为主，其中发热和腹泻症状在每组中均有个案报告，但发生率差异无统计学意义（均P>0.05）。不良反应症状多为一过性，自行缓解，均痊愈。 结论： 3~5月龄婴儿联合接种MPCV-ACYW与IPV或DTaP疫苗具有良好的安全性。.