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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-05-31

Brief Summary

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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?

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Detailed Description

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Conditions

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Influenza A Virus, H1N1 Subtype

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Anti-H1N1v Vaccine

Group Type EXPERIMENTAL

Anti-H1N1v Vaccine

Intervention Type BIOLOGICAL

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

Interventions

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Anti-H1N1v Vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes