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2004 - 2006年新西兰一种新型B群脑膜炎球菌疫苗的上市后安全性监测

Post-marketing safety monitoring of a new group B meningococcal vaccine in New Zealand, 2004-2006.

作者信息

McNicholas Anne, Galloway Yvonne, Stehr-Green Paul, Reid Stewart, Radke Sarah, Sexton Kerry, Kieft Charlotte, Macdonald Claire, Neutze Jocelyn, Drake Ross, Isaac Dorothy, O'Donnell Mary, Tatley Michael, Oster Philipp, O'Hallahan Jane

机构信息

Meningococcal Vaccine Strategy, Ministry of Health, Wellington, New Zealand.

出版信息

Hum Vaccin. 2007 Sep-Oct;3(5):196-204. doi: 10.4161/hv.3.5.4458. Epub 2007 May 18.

DOI:10.4161/hv.3.5.4458
PMID:17660718
Abstract

New Zealand introduced a new outer membrane vesicle vaccine in 2004 to combat an epidemic of group B meningococcal disease. An Independent Safety Monitoring Board oversaw intensive safety monitoring, which included hospital surveillance, health professional reporting (passive and active) and mortality monitoring. With over three million doses administered to individuals aged under 20 years, the monitoring results provide consistent evidence supporting the vaccine's safety.

摘要

2004年，新西兰推出了一种新型外膜囊泡疫苗，以应对B群脑膜炎球菌病的流行。一个独立安全监测委员会负责监督密集的安全监测工作，其中包括医院监测、卫生专业人员报告（被动和主动）以及死亡率监测。在向20岁以下人群接种了超过300万剂疫苗后，监测结果提供了支持该疫苗安全性的一致证据。

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