Influenza A Virus, H1N1 SubtypePhase 4FLU-HOPNCT01063608
Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Medical Staff.
A Phase 4 study testing Anti-H1N1v Vaccine in people with Influenza A Virus, H1N1 Subtype, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
Trial summary
This project may help to answer several fundamental questions related to public health regarding vaccination against influenza viruses and regarding the influenza A(H1N1)v pandemy: What is the immunologic efficacy in terms of antibodies response of the vaccination against the seasonal (2009-2010) influenza virus and… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza A Virus, H1N1 Subtype
- What is being tested?
- Anti-H1N1v Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2009to May 2010
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Age superior or equal to 20 years
- Women with childbearing potential using contraception
Who cannot join
- Documented immune depression
- Current immunosuppressive therapy
- Pregnancy (documented by a positive pregnancy test)
- Breast feeding women
- Documented allergy or hypersensitivity to vaccines
- Documented acute or chronic inflammatory disease
- Concomitant participation to another clinical trial
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Pitie Salpetriere
Paris, Île-de-France Region, 75013
Centre d'Investigations Cliniques (CIC), Hopital Cochin
Paris, Île-de-France Region, 75014
About this study
Official title: Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Clinical Staff (FLU-HOP)
This project may help to answer several fundamental questions related to public health regarding vaccination against influenza viruses and regarding the influenza A(H1N1)v pandemy:
What is the immunologic efficacy in terms of antibodies response of the vaccination against the seasonal (2009-2010) influenza virus and against the A(H1N1)v virus in the clinical staff?
Read more
Moreover, it may help to answer questions related to the use of a vaccine against influenza virus variants emerging in the French population:
- Before the vaccination:
- What is the status of the residual anti-H1N1 seasonal viruses immunity and of the anti-A(H1N1)v immunity in the population stratified by age and taking into account the multiplicity of the prior seasonal vaccinations?
- What is the level of the cellular and humoral cross-reactivity between the different H1N1 strains?
- After the vaccination:
- What is the intensity of the anti-vaccine immune response as a function of the age of the population ad of the prior seasonal vaccinations?
- What is the level of the cellular and humoral cross-reactivity after vaccination as a function of the age of the population and of the multiplicity of the prior seasonal vaccinations?
- Conditions
- Influenza A Virus, H1N1 Subtype
- Being tested
- Anti-H1N1v Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-H1N1v VaccineBiological
Inclusion of hospital personnel in the context of the anti-H1N1v prophylaxy plan.
| Study group | Role | What they receive |
|---|---|---|
| Anti-H1N1v Vaccine | Experimental | Not described Receives: Biological: Anti-H1N1v Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the intensity of the humoral and cellular immune responses of the anti-A(H1N1)v vaccine in a medical care population as a function of the age and of the prior seasonal anti-influenza vaccinations.
Measured: 5 months
Secondary outcomes (5)
Investigate the quality of the humoral and cellular immune responses induced by the seasonal anti-influenza vaccine as a function of the age and of the prior seasonal vaccinations.
Measured: 5 months
Determine the cross-reactivity of the humoral and cellular immune responses as a function of the age and of the prior seasonal vaccinations
Measured: 5 months
Assess the tolerance to the seasonal and pandemic vaccines
Measured: 5 months
Assess the occurence of flu episodes and their severity during the 2009-2010 season as a function of the age of the population. Then, the correlation between the flu episodes and and the immunologic results is to be evaluated.
Measured: 5 months
Evaluate the perception of the anti-influenza vaccination in a medical care population in the current H1N1v pandemy context.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionMay 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 Influenza A Virus, H1N1 SubtypeStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Stephane Jaureguiberry, MD, Principal investigator, Groupe Hospitalier Pitie-SalpetriereBehazine Combadiere, PhD, Study director, INSERM U945
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063608
- Sponsor's protocol ID
- C09-30
- Other IDs
- 2009-016267-11, 2009
- Acronym
- FLU-HOP
- Status last verified
- Mar 2010
- First submitted
- 4 Feb 2010
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonduelle O, Yahia N, Siberil S, Benhabiles N, Carrat F, Krivine A, Rozenberg F, Dimitrov J, Kaveri SV, Curjol A, Tindel M, Louet M, Desert F, Launay O, Loulergue P, Badre G, Katlama C, Bricaire F, Samri A, Rousset D, van der Werf S, Jaureguiberry S, Combadiere B. Longitudinal and integrative biomodeling of effector and memory immune compartments after inactivated influenza vaccination. J Immunol. 2013 Jul 15;191(2):623-31. doi: 10.4049/jimmunol.1203483. Epub 2013 Jun 17.
PubMed 23776176
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Clinical Staff (FLU-HOP)
- ClinicalTrials.gov ID
- NCT01063608
- Acronym / sponsor ID
- FLU-HOP / C09-30
- Conditions
- Influenza A Virus, H1N1 Subtype
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 Feb 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.
This project may help to answer several fundamental questions related to public health regarding vaccination against influenza viruses and regarding the influenza A(H1N1)v pandemy:
What is the immunologic efficacy in terms of antibodies response of the vaccination against the seasonal (2009-2010) influenza virus and against the A(H1N1)v virus in the clinical staff?
Moreover, it may help to answer questions related to the use of a vaccine against influenza virus variants emerging in the French population:
- Before the vaccination:
- What is the status of the residual anti-H1N1 seasonal viruses immunity and of the anti-A(H1N1)v immunity in the population stratified by age and taking into account the multiplicity of the prior seasonal vaccinations?
- What is the level of the cellular and humoral cross-reactivity between the different H1N1 strains?
- After the vaccination:
- What is the intensity of the anti-vaccine immune response as a function of the age of the population ad of the prior seasonal vaccinations?
- What is the level of the cellular and humoral cross-reactivity after vaccination as a function of the age of the population and of the multiplicity of the prior seasonal vaccinations?
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-H1N1v Vaccine | Experimental | Biological: Anti-H1N1v Vaccine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Age superior or equal to 20 years
- Women with childbearing potential using contraception
Key exclusion criteria (7 listed)
- Documented immune depression
- Current immunosuppressive therapy
- Pregnancy (documented by a positive pregnancy test)
- Breast feeding women
- Documented allergy or hypersensitivity to vaccines
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 |
|---|---|---|
| Anti-H1N1v VaccineInclusion of hospital personnel in the context of the anti-H1N1v prophylaxy plan. | Biological | Anti-H1N1v Vaccine |
Primary outcome
Evaluation of the intensity of the humoral and cellular immune responses of the anti-A(H1N1)v vaccine in a medical care population as a function of the age and of the prior seasonal anti-influenza vaccinations.
Time frame: 5 months
5 secondary outcomes
Investigate the quality of the humoral and cellular immune responses induced by the seasonal anti-influenza vaccine as a function of the age and of the prior seasonal vaccinations.
Time frame: 5 months
Determine the cross-reactivity of the humoral and cellular immune responses as a function of the age and of the prior seasonal vaccinations
Time frame: 5 months
Assess the tolerance to the seasonal and pandemic vaccines
Time frame: 5 months
Assess the occurence of flu episodes and their severity during the 2009-2010 season as a function of the age of the population. Then, the correlation between the flu episodes and and the immunologic results is to be evaluated.
Time frame: 5 months
Evaluate the perception of the anti-influenza vaccination in a medical care population in the current H1N1v pandemy context.
Time frame: 5 months
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 9 Oct 2026.
- Results publication: PubMed 23776176Bonduelle O, Yahia N, Siberil S, Benhabiles N, Carrat F, Krivine A, Rozenberg F, Dimitrov J, Kaveri SV, Curjol A, Tindel M, Louet M, Desert F, Launay O, Loulergue P, Badre G, Katlama C, Bricaire F, Samri A, Rousset D, van der Werf S, Jaureguiberry S, Combadiere B. Longitudinal and integrative biomodeling of effector and memory immune compartments after inactivated influenza vaccination. J Immunol. 2013 Jul 15;191(2):623-31. doi: 10.4049/jimmunol.1203483. Epub 2013 Jun 17.
- Publication report ResultsLink provided by the sponsor.
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.
Stephane Jaureguiberry, MD principal investigator
Groupe Hospitalier Pitie-Salpetriere
Behazine Combadiere, PhD study director
INSERM U945
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anti-H1N1v Vaccine in people with Influenza A Virus, H1N1 Subtype, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 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 3 inclusion and 7 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluation of the intensity of the humoral and cellular immune responses of the anti-A(H1N1)v vaccine in a medical care population as a function of the age and of the prior seasonal anti-influenza vaccinations. (time frame: 5 months). 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 NCT01063608, 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 9 Oct 2026.