Immunogenicity and safety of a tetravalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine
Immunogenicity and safety of a tetravalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine
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DOI：
10.1080/00365549950164472
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发表时间：
1999-01-01
影响因子：
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通讯作者：
Heron, I
中科院分区：
文献类型：
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作者：
Gyhrs, A;Lyngholm, E;Heron, I
本研究的目的是探讨含有白喉、破伤风、单组分无细胞百日咳和灭活脊髓灰质炎病毒的四价疫苗(DTaP-IPV)是否具有免疫原性和安全性。儿童在3、5和12个月时(n=186)接种DTAP-IPV(12.5 LF、7 LF、40µg、40、8、32 DU)，或(Ii)在5、6和15个月时接种DT-IPV(50 LF、12.5 LF、40、8、32 DU)，并在5、9周和10个月时接种全细胞百日咳疫苗(大于或等于4IU)(n=84)，未见低张低反应或其他与疫苗相关的严重不良反应。研究中的疫苗(DTaP-IPV)的局部反应、发烧和哭闹与现有DT-IPV疫苗的反应相似，在完成接种计划一个月后，所有儿童的抗体都超过了定义的脊髓灰质炎、破伤风和白喉保护性抗体浓度。对于百日咳毒素，研究疫苗组有明显好的反应，因此，我们得出结论，当按测试方案使用时，四价DTaP-IPV疫苗是安全的和免疫原性的，此外，该疫苗和接种方案减少了就诊次数和必要的注射次数。
The objective of this study was to investigate whether a tetravalent vaccine containing diphtheria, tetanus, monocomponent acellular pertussis and inactivated poliovirus (DTaP-IPV) was immunogenic and safe compared with the vaccination regime used in Denmark at the time of the study, The study mas performed as an open controlled study in which 270 Danish children were enrolled at their 5 weeks' routine examination. The children were allocated to receive either (i) DTaP-IPV (12.5 Lf, 7 Lf, 40 mu g, 40, 8, 32 DU) at 3, 5 and 12 months of age (n = 186) or (ii) DT-IPV (50 Lf, 12.5 Lf, 40, 8, 32 DU) at 5, 6 and 15 months of age plus whole-cell pertussis vaccine (greater than or equal to 4 IU) at 5 and 9 weeks and at 10 months of age (n = 84), No hypotonic hyporesponsive episodes or other vaccine-related serious adverse events were seen. Local reactions, febrile and crying episodes with the investigational vaccine (DTaP-IPV) were similar to the reactions seen with the existing DT-IPV vaccine, One month after completing the vaccination schedule, all children had antibodies above the defined protective antibody concentrations to polio, tetanus and diphtheria. For pertussis toxin, there was a significantly better response in the investigational vaccine group, We therefore conclude that, when used according to the schedule tested, the tetravalent DTaP-IPV vaccine is safe and immunogenic, In addition, the number of visits and the number of injections necessary are reduced with this vaccine and vaccination schedule.