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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Influenza

Intervention / Treatment
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* Biological: Non-adjuvanted A(H1N1)v influenza vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaccine<br> | Biological: Non-adjuvanted A(H1N1)v influenza vaccine<br>* 15 mcg HA/0.5 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Vaccine, Pregnancy