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CompletedNCT01063608FLU-HOPUpdated Sep 4, 2025

Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Medical Staff.

A Phase 4 interventional study of Anti-H1N1v Vaccine in Influenza A Virus, H1N1 Subtype, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 2 sites in France. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
147
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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 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:

  1. 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?
  2. 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?
02

Conditions studied

  • Influenza A Virus, H1N1 Subtype
03

In context

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 375 studies on the registry; 82 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers
  • Age superior or equal to 20 years
  • Women with childbearing potential using contraception

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
147 participants (actual)

Study arms

  • Experimental
    Anti-H1N1v Vaccine

    Biological: Anti-H1N1v Vaccine

Interventions

  • BiologicalAnti-H1N1v Vaccine

    Inclusion of hospital personnel in the context of the anti-H1N1v prophylaxy plan.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Assess the tolerance to the seasonal and pandemic vaccines

    Time frame: 5 months

  4. 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

  5. Evaluate the perception of the anti-influenza vaccination in a medical care population in the current H1N1v pandemy context.

    Time frame: 5 months

07

Study locations

2 sites
  • Hopital Pitie Salpetriere
    Paris, Île-de-France Region 75013, France
  • Centre d'Investigations Cliniques (CIC), Hopital Cochin
    Paris, Île-de-France Region 75014, France
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01063608
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Feb 5, 2010
Start date
Oct 2009
Primary completion
Dec 2009
Completion
May 2010
Last update
Sep 4, 2025

Study contacts

Stephane Jaureguiberry, MD
principal investigator · Groupe Hospitalier Pitie-Salpetriere
Behazine Combadiere, PhD
study director · INSERM U945

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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