David Silke, Vermeer-de Bondt Patricia E, van der Maas Nicoline A T
RIVM, Centre for Infectious Disease Control Netherlands, Preparedness and Response Unit, P.O. Box 1, 3720 BA Bilthoven, The Netherlands.
Vaccine. 2008 Oct 29;26(46):5883-7. doi: 10.1016/j.vaccine.2008.07.105. Epub 2008 Sep 4.
In addition to the routine enhanced passive safety surveillance of the Dutch National Vaccination Programme, RIVM (National Institute for Public Health and the Environment) started a large questionnaire study enrolling approximately 53,000 children from December 2003 until September 2007.
We intended to establish accurate frequency estimates for several more severe adverse events and to compare the incidence rates of three different infant vaccines that were used consecutively.
Whole cell pertussis (wP) DTP-IPV-Hib vaccine (NVI) was replaced by acellulair pertussis (aP) in 2005, first Infanrix-IPV-Hib (GSK) followed by Pediacel (Sanofi) in 2006. Pneumococcal vaccine, Prevenar (Wyeth), was added for children born from April 2006.
Parents returned 28,796 questionnaires (response 54%), 15,069 for whole cell pertussis and 13,727 for acellular pertussis vaccine, including 4485 with pneumococcal vaccine. The OR for reported events was 3-6 for whole cell pertussis vaccine compared with acellular vaccine. This was true for prolonged crying for 3h and more after the first dose (1.5% versus 0.4%; 95 CI 1.1-1.9 and 95% CI 0.2-0.7, respectively), and very high fever of 40.5 degrees C and over following the fourth dose (0.8% versus 0.2%; 95% CI 0.5-1.1 and 0.06-0.3, respectively), while possible febrile convulsions were diagnosed only twice after the fourth dose in the whole cell vaccine group and one after acellular pertussis vaccine. Pallor was significantly more frequent after the first dose of whole cell pertussis than after acellulair pertussis vaccination (18.3% versus 3.4%; 95% CI 17.2-19.5 and 95% CI 2.8-4.0 respectively) Collapse after the first dose was rare in both vaccine groups (5 after whole cell vaccine and 1 after acellular vaccine). The addition of conjugated pneumococcal vaccine did not result in statistically significant increased rates of adverse events in the acellular vaccine group.
Whole cell pertussis vaccine showed a significantly higher reactogenicity regarding the adverse events analysed, while addition of conjugated pneumococcal vaccine administered simultaneously with acellular pertussis showed no statistically different adverse event profile.
除了荷兰国家疫苗接种计划的常规强化被动安全监测外，荷兰国家公共卫生与环境研究所（RIVM）于2003年12月至2007年9月启动了一项大型问卷调查研究，招募了约53,000名儿童。
我们旨在确定几种更严重不良事件的准确发生率，并比较连续使用的三种不同婴儿疫苗的发病率。
2005年，全细胞百日咳（wP）白喉-破伤风-灭活脊髓灰质炎-流感嗜血杆菌结合疫苗（NVI）被无细胞百日咳（aP）疫苗取代，2006年先是英凡利康-灭活脊髓灰质炎-流感嗜血杆菌结合疫苗（葛兰素史克），随后是沛儿（赛诺菲）。2006年4月以后出生的儿童添加了肺炎球菌疫苗沛儿（惠氏）。
家长共返回28,796份问卷（回复率54%），全细胞百日咳疫苗组15,069份，无细胞百日咳疫苗组13,727份，其中4485份包含肺炎球菌疫苗。与无细胞疫苗相比，全细胞百日咳疫苗报告事件的比值比为3至6。首次接种后持续哭闹3小时及以上的情况（分别为1.5%对0.4%；95%置信区间1.1 - 1.9和95%置信区间0.2 - 0.7）以及第四次接种后体温达到40.5摄氏度及以上的高热情况（分别为0.8%对0.2%；95%置信区间0.5 - 1.1和0.06 - 0.3）均符合此情况，而全细胞疫苗组在第四次接种后仅诊断出2例可能的热性惊厥，无细胞百日咳疫苗组为1例。首次接种全细胞百日咳疫苗后面色苍白的情况明显比接种无细胞百日咳疫苗后更频繁（分别为18.3%对3.4%；95%置信区间17.2 - 19.5和95%置信区间2.8 - 4.0）。两个疫苗组首次接种后虚脱情况均罕见（全细胞疫苗组5例，无细胞疫苗组1例）。在无细胞疫苗组中添加结合肺炎球菌疫苗并未导致不良事件发生率有统计学意义的增加。
就所分析的不良事件而言，全细胞百日咳疫苗显示出明显更高的反应原性，而在接种无细胞百日咳疫苗的同时添加结合肺炎球菌疫苗并未显示出不良事件情况有统计学差异。
