Immunogenicity and Safety of an Inactivated Non-adjuvanted A(H1N1)v Influenza Vaccine in Pregnant Women
NCT ID: NCT01024400
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2009-11-30
2010-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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vaccine
Non-adjuvanted A(H1N1)v influenza vaccine
15 mcg HA/0.5 ml
Interventions
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Non-adjuvanted A(H1N1)v influenza vaccine
15 mcg HA/0.5 ml
Eligibility Criteria
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Inclusion Criteria
* Pregnancy between 22 and 32 weeks of gestation
* Provides written informed consent
* Covered by French Social Security
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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MCM Vaccines B.V.
INDUSTRY
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Principal Investigators
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Odile Launay, MD
Role: PRINCIPAL_INVESTIGATOR
Groupe hospitalier Cochin Saint Vincent de Paul
Vassilis Tsatsaris, MD
Role: PRINCIPAL_INVESTIGATOR
Groupe hospitalier Cochin Saint Vincent de Paul
Locations
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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, , France
Countries
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References
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Tsatsaris V, Capitant C, Schmitz T, Chazallon C, Bulifon S, Riethmuller D, Picone O, Poulain P, Lewin F, Laine F, Jacqz-Aigrain E, Aboulker JP, Launay O; Inserm C09-33 PREFLUVAC (Immunogenicity and Safety of an Inactivated Nonadjuvanted A[H1N1v] Influenza Vaccine in Pregnant Women) Study Group. Maternal immune response and neonatal seroprotection from a single dose of a monovalent nonadjuvanted 2009 influenza A(H1N1) vaccine: a single-group trial. Ann Intern Med. 2011 Dec 6;155(11):733-41. doi: 10.7326/0003-4819-155-11-201112060-00005.
Other Identifiers
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2009-016660-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C09-33
Identifier Type: -
Identifier Source: org_study_id
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