The Hospital for Sick Children.
Can J Infect Dis Med Microbiol. 2007 Jul;18(4):241-8. doi: 10.1155/2007/289842.
The safety, immunogenicity and lot consistency of a fully liquid, five-component acellular pertussis combination vaccine, comprised of diphteria, tetanus and acellular pertussis, inactivated polio vaccine, Haemophilus influenzae type b (DTaP-IPV-Hib [Pediacel, sanofi pasteur, Canada]) were assessed and compared with that of Hib vaccine reconstituted with the five-component acellular pertussis combination vaccine (DTaP-IPV//Hib, Pentacel [sanofi pasteur, Canada]).
Infants were recruited at vaccine study centres in Montreal, Quebec; Simon Fraser Health Region, British Columbia, and southern Alberta after the protocol had been approved by the relevant institutional ethics committees. Written informed consent was obtained from the parents or guardians of all subjects. At two months of age, the infants were randomly assigned to receive one of three consecutive production lots of DTaP-IPV-Hib by intramuscular injection. Reactions to vaccinations were assessed by parental observation and through telephone interviews conducted by study nurses. Blood samples were obtained at two, six, seven, 18 and 19 months of age for measurement of antibodies to vaccine antigens.
Most injection site and systemic reactions were mild or moderate, and of brief duration. All infants were protected against tetanus, diphtheria and all three polio serotypes after both primary and booster vaccinations. Antibody responses to pertussis antigens were similar to those observed in Swedish infants, in whom the five-component vaccine was shown to be 85% effective. Proportions of infants with antipolyribosylribitol phosphate antibody of 0.15 mug/mL or greater and 1.0 mug/mL or greater, were 97.9% and 88.9%, respectively, following primary immunization, and 100% and 99% following booster vaccination. Safety and immunogenicity results with both reconstituted and fully liquid combination vaccines were comparable.
The fully liquid combination vaccine was comparable in terms of safety and immunogenicity with the reconstituted combination vaccine.
评估并比较全液体五组分无细胞百白破联合疫苗（由白喉、破伤风和无细胞百日咳、灭活脊髓灰质炎疫苗、b 型流感嗜血杆菌组成，商品名：Pediacel，赛诺菲巴斯德，加拿大）与用五组分无细胞百日咳联合疫苗重配的 Hib 疫苗（DTaP-IPV//Hib，Pentacel，赛诺菲巴斯德，加拿大）的安全性、免疫原性和批间一致性。
在方案获得相关机构伦理委员会批准后，在魁北克省蒙特利尔、不列颠哥伦比亚省西蒙弗雷泽健康区和艾伯塔省南部的疫苗研究中心招募婴儿。所有研究对象的父母或监护人均签署了书面知情同意书。在两个月大时，婴儿通过肌肉注射随机分配接受三批连续生产的疫苗中的一种。通过父母观察和研究护士进行的电话访谈评估接种反应。在 2、6、7、18 和 19 个月时采集血样，以测量疫苗抗原的抗体。
大多数注射部位和全身反应为轻度或中度，持续时间短。所有婴儿在基础和加强免疫后均能预防破伤风、白喉和所有三种脊髓灰质炎血清型。百日咳抗原的抗体反应与在瑞典婴儿中观察到的相似，其中五组分疫苗的有效性为 85%。在基础免疫后，抗多聚核糖醇磷酸抗体浓度为 0.15 微克/毫升或更高和 1.0 微克/毫升或更高的婴儿比例分别为 97.9%和 88.9%，在加强免疫后分别为 100%和 99%。重配和全液体联合疫苗的安全性和免疫原性结果相当。
全液体联合疫苗在安全性和免疫原性方面与重配联合疫苗相当。
