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

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France (Other)
Overall Status
Completed
CT.gov ID
NCT01024400
Collaborator
MCM Vaccines B.V. (Industry)
110
Enrollment
5
Locations
1
Arm
8
Duration (Months)
22
Patients Per Site
2.8
Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:
Interventional
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 :
Nov 1, 2009
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: vaccine

Biological: Non-adjuvanted A(H1N1)v influenza vaccine
15 mcg HA/0.5 ml

Outcome Measures

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. [Day 21]

Secondary Outcome Measures

  1. Safety: occurence of local and systemic adverse events [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. [Day 42 and at delivery]

  3. Safety:occurence of vaccine-associated serious adverse events [Throughout the course of the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 CHU de Besançon-Hôpital Saint-Jacques Besançon France 25030
2 Hôpital Antoine Béclère Clamart France 92141
3 Groupe hospitalier Cochin Saint Vincent de Paul Paris France 75679
4 Hôpital Robert Debré Paris France 75935
5 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

  • Principal Investigator: Odile Launay, MD, Groupe hospitalier Cochin Saint Vincent de Paul
  • Principal Investigator: Vassilis Tsatsaris, MD, Groupe hospitalier Cochin Saint Vincent de Paul

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
First Posted:
Dec 2, 2009
Last Update Posted:
Jan 2, 2012
Last Verified:
Mar 1, 2011
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France
Influenza
Vaccine
Pregnancy
Additional relevant MeSH terms:
Influenza, Human

Study Results

No Results Posted as of Jan 2, 2012