The purpose of this study is to evaluate the immunogenicity and safety of an inactivated, non adjuvanted A(H1N1)v influenza vaccine in 120 pregnant women. Study procedures will include 2 doses of vaccine, blood samples, cord blood samples at delivery and recording temperature and vaccine side effects in a memory aid for 7 days following each vaccination. Participants will be involved in study related procedures about 3 at 5 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
110
15 mcg HA/0.5 ml
CHU de Besançon-Hôpital Saint-Jacques
Besançon, France
Hôpital Antoine Béclère
Clamart, France
Groupe hospitalier Cochin Saint Vincent de Paul
Paris, France
Hôpital Robert Debré
Paris, France
Immunogenicity: proportion of subjects achieving a serum HAI antibody titer of greater than or equal to 1:40, proportion of subjects with 4-fold or greater HAI antibody titer increases against H1N1 2009 virus following H1N1 vaccine.
Time frame: Day 21
Safety: occurence of local and systemic adverse events
Time frame: Throughout the course of the study
Immunogenicity: proportion of subjects achieving a serum HAI antibody titer of greater than or equal to 1:40, proportion of subjects with 4-fold or greater HAI antibody titer increases against H1N1 2009 virus following H1N1 vaccine.
Time frame: Day 42 and at delivery
Safety:occurence of vaccine-associated serious adverse events
Time frame: Throughout the course of the study
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Hôpital Sud de Rennes
Rennes, France