240
Participants
Start Date
September 30, 2011
Primary Completion Date
May 31, 2013
Study Completion Date
May 31, 2013
Placebo
0.2 ml of Intranasal placebo study product (using sucrose phosphate placebo filled sprayers), will be administered to maternal subjects.
Cold-adapted live attenuated influenza virus vaccine, trivalent
Licensed product formulated for the 2011-2012 or 2012-2013 influenza season. Standard dose LAIV (Flumist®) 0.1 ml administered to maternal subjects intranasally in each nostril for a total of 0.2 mL.
Placebo
0.5 ml of Sterile saline (0.9 percent Sodium Chloride for injection), administered IM to maternal subjects.
Trivalent inactivated influenza vaccine
Preservative free, licensed product formulated for the 2011-2012 or 2012-2013 influenza season. Standard dose of TIV (Fluzone®) 0.5 ml administered to maternal subjects, IM in the deltoid.
Washington Hospital Center - Obstetrics and Gynecology, Washington D.C.
Emory Children's Center - Pediatric Infectious Diseases, Atlanta
Saint Louis University - Center for Vaccine Development, St Louis
Duke Translational Medicine Institute - Clinical Vaccine Unit, Durham
Cincinnati Children's Hospital Medical Center - Infectious Diseases, Cincinnati
Group Health Research Institute - Seattle, Seattle
National Institute of Allergy and Infectious Diseases (NIAID)
NIH