An assessment of the safety of adolescent and adult tetanus-diphtheria-acellular pertussis (Tdap) vaccine, using active surveillance for adverse events in the Vaccine Safety Datalink

被引：64
|
作者：
Yih, W. Katherine [1 ]
Nordin, James D. [2 ]
Kulldorff, Martin
Lewis, Edwin [3 ]
Lieu, Tracy A. [4 ]
Shi, Ping
Weintraub, Eric S. [5 ]
机构：
[1] Harvard Univ, Sch Med, Dept Ambulatory Care & Prevent, Boston, MA 02215 USA
[2] Healthpartners Res Fdn, Minneapolis, MN USA
[3] Kaiser Permanente, Vaccine Study Ctr, Oakland, CA USA
[4] Childrens Hosp, Div Gen Pediat, Boston, MA 02115 USA
[5] Ctr Dis Control & Prevent, Immunizat Safety Off, Atlanta, GA USA
来源：
VACCINE | 2009年 / 27卷 / 32期
关键词：
Vaccine safety; Sequential analysis; Bacterial vaccines; GUILLAIN-BARRE-SYNDROME; REPORTING SYSTEM; UNITED-STATES; QUALITY;
D O I：
10.1016/j.vaccine.2009.05.036
中图分类号：
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号：
100102 ;
摘要：
Using a new sequential analytic method, the safety of tetanus-diphtheria-acellular pertussis (Tdap) vaccine was monitored weekly among subjects aged 10-64 years during 2005-2008. Encephalopathy-encephalitis-meningitis, paralytic syndromes, seizures, cranial nerve disorders, and Guillain-Barre syndrome were selected as outcomes based on previous reports and biologic plausibility. The risk following Tdap was not significantly higher than the risk after Td. Statistical power was sufficient to detect a relative risk of 4-5 for Guillain-Barre syndrome and 1.5-2 for the other outcomes. This study provides reassurance that Tdap is similar in safety to Td regarding the outcomes studied and supports the viability of sequential analysis for post-licensure vaccine safety monitoring. (C) 2009 Elsevier Ltd. All rights reserved.
引用
收藏
页码：4257 / 4262
页数：6
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