van der Maas Nicoline A T, Kemmeren Jeanet M, de Melker Hester E
Rijksinstituut voor Volksgezondheid en Milieu, Centrum Infectieziektebestrijding, Bilthoven, The Netherlands.
Ned Tijdschr Geneeskd. 2009;153:A964.
To study the safety profile of the bivalent human papillomavirus (HPV) vaccine following administration of a first dose to 192,119 13-16-year-old girls in the context of a catch-up campaign.
Descriptive.
The safety of the HPV campaign underwent surveillance in three ways: via a spontaneous reporting system, whereby anyone could report a possible undesirable effect; following completion and validation a diagnosis was made and the causal relationship with the vaccination assessed. Secondly, general healthcare service (GGD) physicians reported effects that occurred during the vaccination sessions. Thirdly, we conducted a questionnaire survey of frequent possible side effects, in which we asked about effects that occurred up to 1 week after the vaccine.
446 reports were received via the spontaneous reporting system (degree of reporting: 23.2:10,000). 16% of reports were mainly local effects; 84% were systemic effects, including 8 severe effects. 157 girls consulted their general practitioner or went to a hospital (degree of reporting: 8:10,000). 59% of the reports were of a side effect; in 41% a concurrent event was coincidental. There were 638 reports during the vaccination sessions (degree of reporting 45:10,000). The largest number were vasovegetative effects, including fainting or near-fainting (n = 569; degree of reporting: 40:10,000). The degree of reporting of tightness of the chest or skin effects was 2:10,000. The assistance of a general practitioner or ambulance was summoned for 10 girls (degree of reporting: 0.7:10,000). The questionnaire study (response 68.7%; n = 3646) showed that 92.1% of the girls had local effects. In 1.6% these symptoms were severe. Systemic effects occurred in 91.7%; 0.7% had fever (>or= 39.5 degrees C). 1.5% of girls called for medical assistance.
During intensive surveillance of safety of the HPV campaign, no unexpected or serious side effects with a causal relationship with the vaccination occurred following administration of 192,119 doses. In accordance with data from foreign studies, side effects may be common, but are in general mild and short-lived.
在补种活动中，研究二价人乳头瘤病毒（HPV）疫苗对192,119名13至16岁女孩接种首剂后的安全性。
描述性研究。
通过三种方式对HPV疫苗接种活动的安全性进行监测：一是通过自发报告系统，任何人都可报告可能的不良反应，完成报告并验证诊断后，评估其与疫苗接种的因果关系；二是普通医疗服务（GGD）医生报告接种期间出现的不良反应；三是针对常见的可能副作用开展问卷调查，询问接种疫苗后1周内出现的不良反应。
通过自发报告系统共收到446份报告（报告率：23.2/10,000）。16%的报告主要为局部反应；84%为全身反应，其中8例为严重反应。157名女孩咨询了她们的全科医生或前往医院就诊（报告率：8/10,000）。59%的报告为副作用；41%的报告为同时发生的偶发事件。接种期间有638份报告（报告率45/10,000）。数量最多的是血管迷走性反应，包括昏厥或接近昏厥（n = 569；报告率：40/10,000）。胸部紧绷或皮肤反应的报告率为2/10,000。有10名女孩呼叫了全科医生或救护车（报告率：0.7/10,000）。问卷调查（回复率68.7%；n = 3646）显示，92.1%的女孩有局部反应。其中1.6%的症状较为严重。全身反应发生率为91.7%；0.7%的女孩发烧（≥39.5℃）。1.5%的女孩寻求医疗帮助。
在对HPV疫苗接种活动安全性的强化监测中，接种192,119剂疫苗后，未出现与疫苗接种有因果关系的意外或严重副作用。与国外研究数据一致，副作用可能较为常见，但一般症状轻微且持续时间较短。
