Influenza Clinical Trial
— PREFLUVACOfficial title:
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | July 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | 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 | Hôpital Sud de Rennes | Rennes |
Lead Sponsor | Collaborator |
---|---|
Institut National de la Santé Et de la Recherche Médicale, France | Sanofi Pasteur MSD |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Safety: occurence of local and systemic adverse events | Throughout the course of the study | Yes | |
Secondary | 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 | No | |
Secondary | Safety:occurence of vaccine-associated serious adverse events | Throughout the course of the study | Yes |
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