Garcia 2012.

Trial name or title	Clinical trial to evaluate the immunogenicity and safety of the 2011‐2012 vaccine against seasonal influenza on pregnant women
Methods	Open label non‐randomised study proposing that the 2011‐2012 seasonal influenza vaccine (including H3N2 and H1N1 subtypes of serotype A strain over the serotype B) administered to 15 ug (without adjuvant) via intramuscular in pregnant women will be safe and immunogenic.
Participants	Pregnant women from 14 to 34 weeks of gestation aged 18 to 39 years and had made at least 1 prenatal visit to confirm the pregnancy and available for follow‐up time.
Interventions	2011‐2012 seasonal trivalent inactivated influenza vaccine (include A/California/7/2009 (H1N1)‐like, A/Perth/16/2009 (H3N2)‐like, and B/Brisbane/60/2008‐like antigens) administered to 15 ug without adjuvant, via intramuscular in pregnant and nonpregnant women. It is recommended that vaccines for use in the 2012‐2013 influenza season (northern hemisphere winter) contain the following: an A/California/7/2009 (H1N1)pdm09‐like virus; an A/Victoria/361/2011 (H3N2)‐like virus; a B/Wisconsin/1/2010‐like virus.
Outcomes	Immunogenecity and pregnancy outcomes.
Starting date	April 2012.
Contact information	Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico. freyes.ld@gmail.com
Notes	This study is not yet open for participant recruitment.