Post-marketing safety of domestic Sabin-strain inactivated poliovirus vaccine primary series and booster doses when combined with other vaccines given to infants and young children
Objective To evaluate the post-marketing safety of a domestic Sabin-strain inactivated poliovirus vaccine(sIPV)primary series and booster doses when combined with other vaccines given to infants and young children.Methods We recruited 2-and 18-26-month-old subjects from two counties of Jiangxi province for 3-dose primary and 1-dose booster vaccination with sIPV,respectively.Subjects randomly received sIPV alone or sIPV combined with another vaccine.We collected data on adverse reactions within 30 days after each dose to determine adverse reaction incidences.Results In total,1 999 and 1 199 subjects were included into the primary vaccination group and the booster vaccination group,respectively.The overall incidence of adverse reaction among subjects of the primary group was 1.77％(103/5 823),with 1.81％(71/3 926)for sIPV alone and 1.69％(32/1 897)for sIPV combined with diphtheria,tetanus and acellular pertussis combined vaccine(x2=0.11,P=0.742).The overall incidence of adverse reactions in the booster group was 2.67％(32/1 199),with 2.25％(9/400)for sIPV standalone and 2.88％(23/799)for sIPV combined with any of three other vaccines(X2=0.41,P=0.524).All adverse reactions were grade 1 to 3;no grade 4 or serious reactions were reported.Conclusion Domestic sIPV had a good safety profile in primary series and booster dose administration when given alone and when given with other routine vaccines.
万方数据
维普
