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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Non-adjuvanted A(H1N1)v influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • CHU de Besançon-Hôpital Saint-Jacques
  • Clamart, France, 92141
    • Hôpital Antoine Béclère
  • Paris, France, 75935
    • Hopital Robert Debre
  • Paris, France, 75679
    • Groupe Hospitalier Cochin Saint Vincent de Paul
  • Rennes, France, 35056
    • HOPITAL SUD de RENNES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vaccine	Biological: Non-adjuvanted A(H1N1)v influenza vaccine; 15 mcg HA/0.5 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Safety: occurence of local and systemic adverse events	Throughout the course of the study
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
Safety:occurence of vaccine-associated serious adverse events	Throughout the course of the study

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Collaborators: 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

Publications and helpful links

General Publications

• Tsatsaris V, Capitant C, Schmitz T, Chazallon C, Bulifon S, Riethmuller D, Picone O, Poulain P, Lewin F, Laine 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. doi: 10.7326/0003-4819-155-11-201112060-00005.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (Estimated): December 2, 2009

Study Record Updates

• Last Update Posted (Estimated): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Pregnancy; Influenza; Vaccine
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: C09-33; 2009-016660-36 (EudraCT Number)