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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
History of Changes

November 30, 2009
December 29, 2011
November 2009
January 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01024400 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety of an Inactivated Non-adjuvanted A(H1N1)v Influenza Vaccine in Pregnant Women
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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
Biological: Non-adjuvanted A(H1N1)v influenza vaccine
15 mcg HA/0.5 ml
Experimental: vaccine
Intervention: Biological: Non-adjuvanted A(H1N1)v influenza vaccine
Tsatsaris V, Capitant C, Schmitz T, Chazallon C, Bulifon S, Riethmuller D, Picone O, Poulain P, Lewin F, Lainé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
July 2010
January 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01024400
C09-33, 2009-016660-36
Yes
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Sanofi Pasteur MSD
Principal Investigator: Odile Launay, MD Groupe hospitalier Cochin Saint Vincent de Paul
Principal Investigator: Vassilis Tsatsaris, MD Groupe hospitalier Cochin Saint Vincent de Paul
Institut National de la Santé Et de la Recherche Médicale, France
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP