A(H1N1)v2009: A controlled observational prospective cohort study on vaccine safety in pregnancy

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• 作者：Marc Oppermann^a ; ¹ ; Juliane Fritzsche^a ; ¹ ; Corinna Weber-Schoendorfer^a ; Brigitte Keller-Stanislawski^b ; Arthur Allignol^c ; ^d ; Reinhard Meister^e ; Christof Schaefer^a ; ^{christof.schaefer@charite.de}
• 关键词：Drug safety ; Influenza A(H1N1)v2009 ; H1N1 pandemic vaccine ; Malformation ; Pregnancy ; Teratology
• 刊名：Vaccine
• 出版年：2012
• 期刊代码：89_0264410x
• 类别：imm
• 出版时间：22 June, 2012
• 卷：30
• 期：30
• 页码：4445-4452
• 文件大小：507 K

摘要

<h4 class="h4">Backgroundh4>A(H1N1)v2009 influenza vaccination of pregnant women was a challenge for health care providers, as little safety data were available.<h4 class="h4">Methodsh4>

We prospectively followed the pregnancies of women who were vaccinated at any time during pregnancy or 鈮? weeks prior to conception and compared these outcomes to a control cohort matched by the estimated date of birth. Primary endpoints: rate of spontaneous abortion and major malformations. Secondary endpoints: preeclampsia, gestational age at birth, and birth weight.<h4 class="h4">Resultsh4>

Pregnancy outcome of 323 women immunized with adjuvanted or non-adjuvanted A(H1N1)v2009 influenza vaccines from 2009-09-28 to 2010-03-31 were compared to 1329 control subjects. The risk for spontaneous abortions (HR 0.89; 95%CI 0.36-2.19) and the rate of major malformations (all trimesters: OR 0.87; 95%CI 0.38-1.77; preconception and first trimester exposure: OR 0.79; 95%CI 0.13-2.64) did not vary between the two cohorts. Furthermore, there was no increase in preeclampsia, prematurity, and intrauterine growth retardation in the vaccinated cohort.<h4 class="h4">Conclusionh4>

The results of our study do not indicate a risk for the pregnant woman and the developing embryo/fetus after H1N1 vaccination. We provide and apply methods novel in observational studies on pregnancy outcome, especially if a single dose exposure is investigated.