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

BACKGROUND: A(H1N1)v2009 influenza vaccination of pregnant women was a challenge for health care providers, as little safety data were available. METHODS: We prospectively followed the pregnancies of women who were vaccinated at any time during pregnancy or ≤4 weeks prior to conception and compared...

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Bibliographic Details
Published in:Vaccine 2012, Vol.30 (30), p.4445-4452
Main Authors: Oppermann, Marc, Fritzsche, Juliane, Weber-Schoendorfer, Corinna, Keller-Stanislawski, Brigitte, Allignol, Arthur, Meister, Reinhard, Schaefer, Christof
Format: Article
Language:English
Subjects:
abnormal development
abortion (animals)
birth weight
cohort studies
conception
embryogenesis
fetus
gestational age
growth retardation
health care workers
influenza
observational studies
pre-eclampsia
pregnancy outcome
pregnant women
premature birth
risk
vaccination
vaccines
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Summary:BACKGROUND: A(H1N1)v2009 influenza vaccination of pregnant women was a challenge for health care providers, as little safety data were available. METHODS: We prospectively followed the pregnancies of women who were vaccinated at any time during pregnancy or ≤4 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. RESULTS: 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. CONCLUSION: 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.
ISSN:0264-410X
1873-2518