NCT01063608

Brief 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:

  • 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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

2 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
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

September 4, 2025

Status Verified

March 1, 2010

Enrollment Period

2 months

First QC Date

February 4, 2010

Last Update Submit

August 28, 2025

Conditions

Influenza A Virus, H1N1 Subtype

Outcome Measures

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.

    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.

    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

    5 months

  • Assess the tolerance to the seasonal and pandemic vaccines

    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.

    5 months

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

    5 months

Study Arms (1)

Anti-H1N1v Vaccine

EXPERIMENTAL
Biological: Anti-H1N1v Vaccine

Interventions

Anti-H1N1v VaccineBIOLOGICAL

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

Anti-H1N1v Vaccine

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Pitie Salpetriere

Paris, Île-de-France Region, 75013, France

Location

Centre d'Investigations Cliniques (CIC), Hopital Cochin

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

  • 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.

    PMID: 23776176BACKGROUND

Related Links

Study Officials

  • Stephane Jaureguiberry, MD

    Groupe Hospitalier Pitié-Salpêtrière

    PRINCIPAL INVESTIGATOR

  • Behazine Combadiere, PhD

    INSERM U945

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2010

First Posted

February 5, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2009

Study Completion

May 1, 2010

Last Updated

September 4, 2025

Record last verified: 2010-03

Locations

FR(2)