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

This study has been completed.
Sponsor:
Collaborator:
Sanofi Pasteur MSD
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01024400
First received: November 30, 2009
Last updated: December 29, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Influenza
Biological: Non-adjuvanted A(H1N1)v influenza vaccine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: occurence of local and systemic adverse events [ Time Frame: Throughout the course of the study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety:occurence of vaccine-associated serious adverse events [ Time Frame: Throughout the course of the study ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: November 2009
Study Completion Date: July 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vaccine Biological: Non-adjuvanted A(H1N1)v influenza vaccine
15 mcg HA/0.5 ml

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024400

Locations
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
Sanofi Pasteur MSD
Investigators
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

No publications provided by Institut National de la Santé Et de la Recherche Médicale, France

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01024400     History of Changes
Other Study ID Numbers: C09-33, 2009-016660-36
Study First Received: November 30, 2009
Last Updated: December 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Influenza
Vaccine
Pregnancy

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 11, 2014