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

Institut National de la Santé Et de la Recherche Médicale, France5 sites in 1 country110 target enrollmentNovember 1, 2009

ConditionsInfluenza

InterventionsNon-adjuvanted A(H1N1)v influenza vaccine

Overview

Phase: Phase 2
Intervention: Non-adjuvanted A(H1N1)v influenza vaccine
Conditions: Influenza
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Enrollment: 110
Locations: 5
Primary Endpoint: 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.
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2009

End Date

July 1, 2010

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

vaccine

Intervention: Non-adjuvanted A(H1N1)v influenza vaccine

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)