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

Institut National de la Santé Et de la Recherche Médicale, France

Status and phase

Completed

Phase 2

Conditions

Influenza

Treatments

Biological: Non-adjuvanted A(H1N1)v influenza vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01024400

2009-016660-36 (EudraCT Number)

C09-33

Details and patient eligibility

About

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.

Enrollment

110 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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