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

Influenza Clinical Trial

— PREFLUVAC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024400
• Other study ID #: C09-33
• Secondary ID: 2009-016660-36
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2009
• Last updated: December 29, 2011
• Start date: November 2009
• Est. completion date: July 2010

Study information

• Verified date: March 2011
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	Sanofi Pasteur MSD

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety: occurence of local and systemic adverse events		Throughout the course of the study	Yes
Secondary	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	No
Secondary	Safety:occurence of vaccine-associated serious adverse events		Throughout the course of the study	Yes