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Safety of the new H1N1 influenza vaccine in pregnancy

Duration: Sept. 2009 - Dec. 2011

Principal investigator: Dr. med. Christof Schaefer (Embryotox, Berlin)

Statistical coordinator: Dr. Reinhard Meister (Beuth Hochschule, Berlin)

Study statistician: Arthur Allignol (IMBI and FDM)


The new H1N1 influenza may pose an increased risk of severe illness in pregnant women, maybe  due to the physiological and immunological  changes happening during pregnancy. Hence the Strategic Advisory Group of Experts on Immunization of the World Health Organization recommends vaccination in pregnant women. In Germany, the vaccine commission of the Robert Koch-Institut recommends that pregnant women be vaccinated preferably from the 2nd trimester and use non-adjuvanted vaccines. Possible teratogenic effects have only been studied for the seasonal  influenza vaccine, and there was no increased risk found so far, though there is not enough data to draw a definitive conclusion. The FDA classifies this vaccine in “Pregnancy category C”. There is no safety data on the adjuvanted version of the vaccine. The aim of this prospective cohort study is therefore to evaluate the possible teratogenic effects of the new H1N1 vaccine, both for the non-adjuvanted and the adjuvanted versions of the vaccine.


Statistical objectives:

Improve the statistical methods used for analysing studies on prenatal drug exposure.