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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Non-adjuvanted A(H1N1)v influenza vaccine

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccine, Pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

CHU de Besançon-Hôpital Saint-Jacques
Hôpital Antoine Béclère
Groupe hospitalier Cochin Saint Vincent de Paul
Hôpital Robert Debré
Hôpital Sud de Rennes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vaccine

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety: occurence of local and systemic adverse events

Safety:occurence of vaccine-associated serious adverse events

Full Information

NCT ID

NCT01024400

First Posted

November 30, 2009

Last Updated

December 29, 2011

Sponsor

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

Collaborators

MCM Vaccines B.V.

1. Study Identification

Unique Protocol Identification Number

NCT01024400

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

Collaborators

MCM Vaccines B.V.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza, Vaccine, Pregnancy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vaccine

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Non-adjuvanted A(H1N1)v influenza vaccine

Intervention Description

15 mcg HA/0.5 ml

Primary Outcome Measure Information:

Title

Time Frame

Day 21

Secondary Outcome Measure Information:

Title

Safety: occurence of local and systemic adverse events

Time Frame

Throughout the course of the study

Title

Time Frame

Day 42 and at delivery

Title

Safety:occurence of vaccine-associated serious adverse events

Time Frame

Throughout the course of the study

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Odile Launay, MD

Organizational Affiliation

Groupe hospitalier Cochin Saint Vincent de Paul

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vassilis Tsatsaris, MD

Organizational Affiliation

Groupe hospitalier Cochin Saint Vincent de Paul

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Besançon-Hôpital Saint-Jacques

City

Besançon

ZIP/Postal Code

25030

Country

France

Facility Name

Hôpital Antoine Béclère

City

Clamart

ZIP/Postal Code

92141

Country

France

Facility Name

Groupe hospitalier Cochin Saint Vincent de Paul

City

Paris

ZIP/Postal Code

75679

Country

France

Facility Name

Hôpital Robert Debré

City

Paris

ZIP/Postal Code

75935

Country

France

Facility Name

Hôpital Sud de Rennes

City

Rennes

ZIP/Postal Code

35056

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

22147712

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.

Results Reference

derived

Learn more about this trial

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

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