Abstract：
To fully understand the safety of DTaP-IPV/Hib vaccination, we evaluated the differences between DTaP-IPV/Hib co-administration and separate administration of the DTaP, IPV and Hib vaccines (DTaP+IPV+Hib) based on adverse events following immunization (AEFI). All AEFI reported in Hebei Province, China, between 2020 and 2022 were included in this study. The risk difference (RD%), relative risk (RR), and Chi-square value were used to compare the differences in reported rates of AEFI between the DTaP-IPV/Hib and DTaP+IPV+Hib groups. From 2020 to 2022, 130 AEFI cases were reported in Hebei Province after DTaP-IPV/Hib vaccination, corresponding to an AEFI reported rate of 66.9/million doses, which was significantly lower than that for DTaP+IPV+Hib (9836 AEFI with a reported rate of 637.8/million doses). The overall reported rate of non-severe AEFI for DTaP+IPV+Hib vaccines was 9.5 times that of DTaP-IPV/Hib vaccination [95% confidence interval (CI): 8.0, 11.3]. Meanwhile, the reported rate of AEFI among infants aged 0-1 y was 9.8 times higher for DTaP+IPV+Hib than for DTaP-IPV/Hib (95% CI: 8.2, 11.7). DTaP+IPV+Hib vaccination also resulted in higher risks of high fever, localized redness and swelling, localized induration, and allergic rash compared with DTaP-IPV/Hib vaccination. The risk of AEFI, which were mostly mild reaction, was higher after vaccination with DTaP+IPV+Hib than after DTaP-IPV/Hib vaccination.
摘要：
为了充分了解DTaP-IPV/Hib疫苗接种的安全性，我们评估了DTaP-IPV/Hib联合给药和DTaP单独给药之间的差异，基于免疫后不良事件(AEFI)的IPV和Hib疫苗(DTaP+IPV+Hib)。所有AEFI在河北省报告，中国,2020年至2022年纳入本研究。风险差异(RD%)，相对风险(RR)，和卡方值用于比较DTaP-IPV/Hib和DTaP+IPV+Hib组之间报告的AEFI率的差异。从2020年到2022年，河北省在DTaP-IPV/Hib疫苗接种后报告了130例AEFI病例，对应于AEFI报告的66.9/百万剂量的比率，显着低于DTaP+IPV+Hib（9836AEFI，报告率为637.8/百万剂量）。DTaP+IPV+Hib疫苗的非重度AEFI总报告率为DTaP-IPV/Hib疫苗接种的9.5倍[95%置信区间(CI):8.0,11.3]。同时,在0~1岁婴儿中,DTaP+IPV+Hib的AEFI报告发生率是DTaP-IPV/Hib的9.8倍(95%CI:8.2,11.7).DTaP+IPV+Hib疫苗也导致更高的高烧风险，局部红肿,局部硬结，与DTaP-IPV/Hib疫苗相比，过敏性皮疹。AEFI的风险，大多是轻微的反应，DTaP+IPV+Hib疫苗接种后高于DTaP-IPV/Hib疫苗接种后。
