Objective To examine adverse local reactions (ALRs) among infants after vaccinated with diphtheria, tetanus and acellular pertussis combined vaccine (DTaP) for evaluating the safety of DTaP vaccination in the infants.
Methods We conducted a proactive surveillance local on DTaP vaccination-induced ALRs among 2 494 healthy infants of 3 - 5 months old at four township health centers in a county of Jiangsu province from July 2020 through March 2021. The identification of ALRs was based on the Guidelines for the Classification of Adverse Events in Clinical Trials of Preventive Vaccines (No.102 of 2019) issued by National Medical Products Administration. The collected data were analyzed with descriptive statistics.
Results Among 2 490 infants finally included in the analysis, 1 009 were identified as having DTaP vaccination-induced ALRs, with an overall incidence rate of 40.52%, and there was no significant gender difference in the incidence rate (40.71% for the boys and 40.33% for the girls, P > 0.05); the incidence rate of grade I and II ALRs were 35.9% and 4.66% and no ALRs of grade III and above was observed in all the infants. Local tissue induration and redness were among the most frequent adverse reactions, accounting for 14.4% and 17.0% of all the ALRs, 38.18% and 42.89% of all grade I ALRs; while, the proportion tissue redness and tenderness were 34.48% and 26.72% for all the grade II ALRs; Almost all (98.0%) the ALRs occurred within 3 days after DTaP inoculation. The incidence rate of local tissue induration and redness differed significantly among the infants inoculated with DTaP from various manufactures (P < 0.05); the incidence rate of induration, swelling, redness and rash were significantly higher among the infants with the second and third dose of DTaP than those among the infants with the first dose vaccine (P < 0.01) and the incidence rate of rash was significantly higher in the infants with the third dose DTaP than that of the infants with the first dose vaccine (P < 0.05).
Conclusion Induration and redness are main adverse local tissue reactions after DTaP vaccination among 3 – 5 months old infants .
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