NCT01192737

Brief Summary

The purpose of this study is to measure the incidence of A/H1N1 Influenza infection in the mother and her child and to identify the determinants in pregnant women during pandemic period in three public maternities in Paris, France.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
919

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

3 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

October 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 4, 2025

Status Verified

April 1, 2012

Enrollment Period

11 months

First QC Date

July 20, 2010

Last Update Submit

November 26, 2025

Conditions

InfluenzaPregnancy

Keywords

pandemicA/H1N1pregnancycohortvaccineInfluenza and Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Frequency of A/H1N1 Influenza virus infection in pregnant women and impact of Flu on pregnancy outcome.

    1 year

Secondary Outcomes (1)

  • Safety of Flu vaccine

    1 year

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women

You may qualify if:

  • \> 18 years
  • Pregnancy between 12 and 35 weeks of gestation, going in one of the following maternity cares: Port Royal, Necker, Saint Vincent de Paul
  • Provides written informed consent
  • Speaks and understands French
  • Covered by French Social Security

You may not qualify if:

  • Not covered by French Social Security
  • Previous H1N1 influenza (virologically documented)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Maternité Necker-Brune

Paris, France

Location

Maternité Port Royal

Paris, France

Location

Maternité Saint Vincent de Paul

Paris, France

Location

Related Publications (1)

  • Launay O, Krivine A, Charlier C, Truster V, Tsatsaris V, Lepercq J, Ville Y, Avenell C, Andrieu T, Rozenberg F, Artiguebielle F, Treluyer JM, Goffinet F; Inserm COFLUPREG Study Group. Low rate of pandemic A/H1N1 2009 influenza infection and lack of severe complication of vaccination in pregnant women: a prospective cohort study. PLoS One. 2012;7(12):e52303. doi: 10.1371/journal.pone.0052303. Epub 2012 Dec 27.

    PMID: 23300637RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, cord blood

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Odile Launay, MD, PhD

    CIC de Vaccinologie Cochin Pasteur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2010

First Posted

September 1, 2010

Study Start

October 1, 2009

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

December 4, 2025

Record last verified: 2012-04

Locations

FR(3)