InfluenzaPhase 2PREFLUVACNCT01024400
Immunogenicity and Safety of an Inactivated Non-adjuvanted A(H1N1)v Influenza Vaccine in Pregnant Women
A Phase 2 study testing Non-adjuvanted A(H1N1)v influenza vaccine in people with Influenza, run by Institut National de la Santé Et de la Recherche Médicale, France at 5 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Influenza
- What is being tested?
- Non-adjuvanted A(H1N1)v influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 5 sitesFrance
- Study dates
- Nov 2009to Jul 2010
- Phase
- Phase 2
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years to 45 years
- Pregnancy between 22 and 32 weeks of gestation
- Provides written informed consent
- Covered by French Social Security
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Besançon-Hôpital Saint-Jacques
Besançon, 25030
Hôpital Antoine Béclère
Clamart, 92141
Groupe hospitalier Cochin Saint Vincent de Paul
Paris, 75679
Hôpital Robert Debré
Paris, 75935
Hôpital Sud de Rennes
Rennes, 35056
About this study
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
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.
- Conditions
- Influenza
- Being tested
- Non-adjuvanted A(H1N1)v influenza vaccine
- Keywords
- Influenza, Vaccine, Pregnancy
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-adjuvanted A(H1N1)v influenza vaccineBiological
15 mcg HA/0.5 ml
| Study group | Role | What they receive |
|---|---|---|
| vaccine | Experimental | Not described Receives: Biological: Non-adjuvanted A(H1N1)v influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 21
Secondary outcomes (3)
Safety: occurence of local and systemic adverse events
Measured: 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.
Measured: Day 42 and at delivery
Safety:occurence of vaccine-associated serious adverse events
Measured: Throughout the course of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2010
- Study completionJul 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- MCM Vaccines B.V.
- Responsible party
- Sponsor
- Investigators
- Odile Launay, MD, Principal investigator, Groupe hospitalier Cochin Saint Vincent de PaulVassilis Tsatsaris, MD, Principal investigator, Groupe hospitalier Cochin Saint Vincent de Paul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024400
- Sponsor's protocol ID
- C09-33
- Other IDs
- 2009-016660-36, 2009
- Acronym
- PREFLUVAC
- Status last verified
- Mar 2011
- First submitted
- 30 Nov 2009
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22147712
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01024400
- Acronym / sponsor ID
- PREFLUVAC / C09-33
- Conditions
- Influenza
- Keywords
- Influenza, Vaccine, Pregnancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- MCM Vaccines B.V.
- Study start
- Nov 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Dec 2009 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccine | Experimental | Biological: Non-adjuvanted A(H1N1)v influenza vaccine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 years to 45 years
- Pregnancy between 22 and 32 weeks of gestation
- Provides written informed consent
- Covered by French Social Security
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-adjuvanted A(H1N1)v influenza vaccine15 mcg HA/0.5 ml | Biological | vaccine |
Primary outcome
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.
Time frame: Day 21
3 secondary outcomes
Safety: occurence of local and systemic adverse events
Time frame: 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.
Time frame: Day 42 and at delivery
Safety:occurence of vaccine-associated serious adverse events
Time frame: Throughout the course of the study
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 10 Dec 2025.
- Results publication: PubMed 22147712Tsatsaris 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.
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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 principal investigator
Groupe hospitalier Cochin Saint Vincent de Paul
Vassilis Tsatsaris, MD principal investigator
Groupe hospitalier Cochin Saint Vincent de Paul
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Non-adjuvanted A(H1N1)v influenza vaccine in people with Influenza, run by Institut National de la Santé Et de la Recherche Médicale, France at 5 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 4 inclusion and 19 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 10 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 5 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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. (time frame: Day 21). 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 NCT01024400, 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 10 Dec 2025.