NCT01024400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

December 10, 2025

Status Verified

March 1, 2011

Enrollment Period

2 months

First QC Date

November 30, 2009

Last Update Submit

December 3, 2025

Conditions

Influenza

Keywords

InfluenzaVaccinePregnancy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

vaccine

EXPERIMENTAL
Biological: Non-adjuvanted A(H1N1)v influenza vaccine

Interventions

Non-adjuvanted A(H1N1)v influenza vaccineBIOLOGICAL

15 mcg HA/0.5 ml

vaccine

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years to 45 years
  • Pregnancy between 22 and 32 weeks of gestation
  • Provides written informed consent
  • Covered by French Social Security

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU de Besançon-Hôpital Saint-Jacques

Besançon, 25030, France

Location

Hôpital Antoine Béclère

Clamart, 92141, France

Location

Groupe hospitalier Cochin Saint Vincent de Paul

Paris, 75679, France

Location

Hôpital Robert Debré

Paris, 75935, France

Location

Hôpital Sud de Rennes

Rennes, 35056, France

Location

Related Publications (1)

  • 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.

    PMID: 22147712RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Odile Launay, MD

    Groupe hospitalier Cochin Saint Vincent de Paul

    PRINCIPAL INVESTIGATOR

  • Vassilis Tsatsaris, MD

    Groupe hospitalier Cochin Saint Vincent de Paul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 2, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2010

Study Completion

July 1, 2010

Last Updated

December 10, 2025

Record last verified: 2011-03

Locations

FR(5)