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

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: Non-adjuvanted A(H1N1)v influenza vaccine

• Registration Number: NCT01024400
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-02
• Primary Completion: 2010-01
• Study Completion: 2010-07
• Status Verified: 2011-03
• Last Update Submitted: 2011-12-29
• Last Update Posted: 2012-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vaccine	Non-adjuvanted A(H1N1)v influenza vaccine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

Hôpital Antoine Béclère; 🇫🇷 Clamart, France

Groupe hospitalier Cochin Saint Vincent de Paul; 🇫🇷 Paris, France

CHU de Besançon-Hôpital Saint-Jacques; 🇫🇷 Besançon, France

Hôpital Robert Debré; 🇫🇷 Paris, France

Hôpital Sud de Rennes; 🇫🇷 Rennes, France