Clinical trial NCT01024400: Immunogenicity and Safety of an Inactivated Non-adjuvanted A(H1N1)v Influenza Vaccine in Pregnant Women
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Vaccine
Pregnancy
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: MCM Vaccines B.V.
First posted: 2009-12-02
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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
* 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

Primary outcomes:
measure: 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.
timeFrame: Day 21
Secondary outcomes:
measure: Safety: occurence of local and systemic adverse events
timeFrame: Throughout the course of the study
measure: 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.
timeFrame: Day 42 and at delivery
measure: Safety:occurence of vaccine-associated serious adverse events
timeFrame: Throughout the course of the study
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon-Hôpital Saint-Jacques
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Paris
country: France
facility: Groupe hospitalier Cochin Saint Vincent de Paul
city: Paris
country: France
facility: Hôpital Robert Debré
city: Rennes
country: France
facility: Hôpital Sud de Rennes
Study officials:
affiliation: Groupe hospitalier Cochin Saint Vincent de Paul
name: Odile Launay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupe hospitalier Cochin Saint Vincent de Paul
name: Vassilis Tsatsaris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.