Format

Send to

Choose Destination
Vaccine. 2012 Jun 22;30(30):4445-52. doi: 10.1016/j.vaccine.2012.04.081. Epub 2012 May 5.

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

Author information

1
Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité - Universitätsmedizin Berlin, Germany.

Abstract

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.

PMID:
22564554
DOI:
10.1016/j.vaccine.2012.04.081
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center