Table 1.

Clinical trials of seasonal and A(H1N1) 2009 vaccines evaluating safety and immunogenicity in pregnant women

Identifier, Clinicaltrials.gov	Year	Vaccine	Comparisons	Pregnant women, n	Design, results
NCT00905125	2008–2009	Trivalent IIV, seasonal	Compared influenza virus vaccines Fluzone® (Sanofi Pasteur, Swiftwater, PA, USA) versus Fluarix® (GlaxoSmithKline, Dresden, Germany). 0·5 ml IM	102	Randomized No safety problems detected. Immunogenicity at 28 days post-vaccination similar for both vaccines
NCT01173211	2010–2011	Trivalent IIV, seasonal	Compared influenza virus vaccines Fluzone®, Fluarix®, and Agriflu® (Novartis Vaccines and Diagnostics Inc., Cambridge, MA, USA). 0·5 ml IM	139 (44 non-pregnant women)	Randomized, pregnant women and non-pregnant controls No safety problems detected. Immunogenicity not reported yet
NCT00963430	2009	Unadjuvanted, inactive H1N1 pandemic	Compared two 25 μg versus two 49 μg of hemagglutinin doses (Sanofi Pasteur), administered 21 days apart	120	Randomized, pregnant women No safety problems detected. Immunogenicity similar for both doses. Published32
NCT00992719	2009	Unadjuvanted, inactive H1N1 pandemic	Compared 15 versus 30 μg of hemagglutinin doses (Novartis Vaccines and Diagnostics Inc.) administered 21 days apart	56 (28 non-pregnant women)	Randomized, pregnant women and non-pregnant controls No safety problems detected. Immunogenicity not reported yet

IIV, inactivated influenza vaccine.