Influenza
Conditions
Keywords
Influenza, Vaccine, Pregnancy
Brief summary
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.
Interventions
15 mcg HA/0.5 ml
Sponsors
MCM Vaccines B.V.
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Day 21 |
Secondary
| Measure | Time frame |
|---|---|
| Safety: occurence of local and systemic adverse events | 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. | Day 42 and at delivery |
| Safety:occurence of vaccine-associated serious adverse events | Throughout the course of the study |
Countries
France
Outcome results
None listed