Meta-analysis of safety and immunogenicity of DTaP-IPV-Hib-HepB hexavaccine / 中国生物制品学杂志

ABSTRACT

@#Objective To compare the differences of safety and immunogenicity of DTaP-IPV-Hib-HepB hexavaccine,DTaPIPV-Hib pentavaccine plus HepB single vaccine or DTaP-IPV-HepB pentavaccine plus Hib single vaccine,so as to provide a reference for the marketing and use of hexavaccine in China.Methods Randomized controlled trials(RCTs)of DTaP-IPVHib-HepB hexavaccine,DTaP triple vaccine,Hib,IPV and HepB vaccines published at home and abroad were searched.The safety and immunogenicity of the hexavaccine were evaluated by Meta-analysis using Revman 5.4.1 software.Results A total of 7 articles,8 RCTs and 3 429 subjects were included. Meta-analysis of safety showed that there was no significant difference in the incidence of injection site and systemic adverse reactions after vaccination with hexavaccine and pentavaccine plus single vaccine(P > 0. 05)except for induration at the inoculation site and crying. Meta-analysis of immunogenicity showed no significant difference in antibody indexes after vaccination with hexavaccine and pentavaccine plus single vaccine(P > 0. 05).Conclusion The safety and immunogenicity of DTaP-IPV-Hib-HepB hexavaccine in basic immunity was comparable to that of the control vaccine,and might be applied to infants and young children to prevent related diseases. However,due to the limitations of the quantity and quality of included studies,the above conclusions still depend on the further development of larger sample,multicenter and high-quality