InfluenzaCOFLUPREGNCT01192737
"COhort Study on A/H1N1 FLU During PREGnancy"
An observational study of Influenza and Pregnancy, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- How many people
- 919 participants
- Where
- 3 sitesFrance
- Study dates
- Oct 2009to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women
Who may be able to join
- > 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
Who cannot join
- Not covered by French Social Security
- Previous H1N1 influenza (virologically documented)
Trial locations and contacts
3 sites in 1 country.
France3 sites
Maternité Necker-Brune
Paris
Maternité Port Royal
Paris
Maternité Saint Vincent de Paul
Paris
About this study
Official title: Cohort Study to Evaluate Clinical Expression and Maternofetal Consequences of A/H1N1 Influenza in Pregnant Women
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.
- Keywords
- pandemic, A/H1N1, pregnancy, cohort, vaccine, Influenza and Pregnancy
- Medical subject headings
- Influenza, Human
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of A/H1N1 Influenza virus infection in pregnant women and impact of Flu on pregnancy outcome.
Measured: 1 year
Secondary outcomes (1)
Safety of Flu vaccine
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 919 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Odile Launay, MD, PhD, Principal investigator, CIC de Vaccinologie Cochin Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192737
- Sponsor's protocol ID
- C09-24
- Other IDs
- 2009-015160-34, 2009
- Acronym
- COFLUPREG
- Status last verified
- Apr 2012
- First submitted
- 20 Jul 2010
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23300637
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study to Evaluate Clinical Expression and Maternofetal Consequences of A/H1N1 Influenza in Pregnant Women
- ClinicalTrials.gov ID
- NCT01192737
- Acronym / sponsor ID
- COFLUPREG / C09-24
- Keywords
- pandemic, A/H1N1, pregnancy, cohort, vaccine, Influenza and Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 919 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (5 listed)
- > 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
Key exclusion criteria (2 listed)
- Not covered by French Social Security
- Previous H1N1 influenza (virologically documented)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of A/H1N1 Influenza virus infection in pregnant women and impact of Flu on pregnancy outcome.
Time frame: 1 year
1 secondary outcome
Safety of Flu vaccine
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 23300637Launay 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.
Related trials for Influenza
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
RecruitingPhase 4
Impact of Egg-Based and Cell-Based Vaccine Platforms on Immune Responses to Repeated Influenza Vaccination
Immunology
RecruitingEarly Phase 1
Intradermal Influenza Vaccination
Vaccine Reaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odile Launay, MD, PhD principal investigator
CIC de Vaccinologie Cochin Pasteur
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Pregnancy, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of A/H1N1 Influenza virus infection in pregnant women and impact of Flu on pregnancy outcome. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01192737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.