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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01024400
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : January 2, 2012
Sponsor:
Collaborator:
MCM Vaccines B.V.
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Study Description
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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.


Condition or disease Intervention/treatment Phase
Influenza Biological: Non-adjuvanted A(H1N1)v influenza vaccine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Study Start Date : November 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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Arm Intervention/treatment
Experimental: vaccine Biological: Non-adjuvanted A(H1N1)v influenza vaccine
15 mcg HA/0.5 ml


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: Day 21 ]

Secondary Outcome Measures :
  1. Safety: occurence of local and systemic adverse events [ Time Frame: Throughout the course of the study ]
  2. 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. [ Time Frame: Day 42 and at delivery ]
  3. Safety:occurence of vaccine-associated serious adverse events [ Time Frame: Throughout the course of the study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024400


Locations
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France
CHU de Besançon-Hôpital Saint-Jacques
Besançon, France, 25030
Hôpital Antoine Béclère
Clamart, France, 92141
Groupe hospitalier Cochin Saint Vincent de Paul
Paris, France, 75679
Hôpital Robert Debré
Paris, France, 75935
Hôpital Sud de Rennes
Rennes, France, 35056
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
MCM Vaccines B.V.
Investigators
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Principal Investigator: Odile Launay, MD Groupe hospitalier Cochin Saint Vincent de Paul
Principal Investigator: Vassilis Tsatsaris, MD Groupe hospitalier Cochin Saint Vincent de Paul
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01024400    
Other Study ID Numbers: C09-33
2009-016660-36 ( EudraCT Number )
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: January 2, 2012
Last Verified: March 2011
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Influenza
Vaccine
Pregnancy
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases