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- W2350656992 abstract "Objective To explore the adverse reaction and serological effect of whole cell DTP and HB(CHO) combined vaccine (DTP-HB vaccine).Methods Select healthy and mature newborns from HBsAg-negative mothers as eligible.In a phase Ⅰ clinical trial, 60 newborns were divided into 3 groups, 20 per group. The newborns in group 1 were inoculated with DTP-HB vaccine at ages of 2,4 and 6 months,and those in group 2 with the combined vaccine at ages of 3,4 and 5 months.However, the newborns in group 3 were inoculated with adsorbed DTP as control at ages of 3,4 and 5 months.Observe the adverse reactions of the newborns in all the 3 groups. In a phase Ⅱ clinical trial,350 newborns were divided into 3 groups randomly.The 118 newborns in group 1 were inoculated with DTP-HB vaccine at ages of 2,4 and 6 months, and the 114 newborns in group 2 with HB and DTP vaccines in left and right arms respectively, at ages of 2,4 and 6 months. However, the 118 newborns in group 3 were inoculated with HB vaccine at ages of 0,1 and 6 months and DTP vaccine at 3,4 and 5 months.Observe the adverse reactions and serological effect in the newborns of the 3 groups.Results In the phase Ⅰ clinical trial, mild systemic reactions were observed in 5%,10% and 20% of newborns in groups 1, 2 and 3 respectively, but no local, moderate or strong systemic reactions. In the phase Ⅱ clinical trial,mild and moderate systemic reactions were observed in 4.24% and 1.69% of newborns in group 1(test group) respectively.Mild local reactions were observed in 0.85% of the newborns, but no moderate or strong local reactions. All the positive conversion rates of pertussis, diphtheria, tetanus and HB antibodies of newborns in test group were more than 90%.Conclusion The adsorbed whole cell DTP-HB vaccine was safe. The combined vaccine inoculated at ages of 2,4 and 6 months induced protective antibodies against pertussis, diphtheria, tetanus and HB." @default.
- W2350656992 created "2016-06-24" @default.
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- W2350656992 date "2004-01-01" @default.
- W2350656992 modified "2023-09-24" @default.
- W2350656992 title "Adverse Reaction and Serological Effect of Adsorbed DTP and HB (CHO) Combined Vaccine" @default.
- W2350656992 hasPublicationYear "2004" @default.
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