Immunogenicity and Safety of an Inactivated Non-adjuvanted A(H1N1)v Influenza Vaccine in Pregnant Women

Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A(H1N1)v Chez la Femme Enceinte

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.

Inclusion Criteria:

• 18 years to 45 years
• Pregnancy between 22 and 32 weeks of gestation
• Provides written informed consent
• Covered by French Social Security

Exclusion Criteria:

• Allergy to eggs or other components in the vaccine
• History of severe reactions following previous influenza vaccines
• H1N1 influenza (virologically documented) during the last 6 months
• Febrile episode within one week prior to vaccination
• Known HIV, HBV, HCV infection
• Multiple sclerosis
• History of Guillain-Barré syndrome
• Organ transplant recipient
• Neoplastic disease in the past 3 years
• Other vaccine within 3 weeks prior to study entry or planned within the month following the last injection
• Systemic corticosteroids,immunotherapy,chemotherapy
• Anticoagulant treatment
• Immunoglobulin or blood transfusion within the 3 months prior to enrollment in this study
• History of cardiac disease
• Chronic liver disease
• Diabetes before pregnancy
• History of premature delivery
• History of eclampsia
• Fetal morphologic abnormalities