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Completed
NCT01063608
Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Medical Staff.
Conditions: Influenza A Virus, H1N1 Subtype
Sex: All
Ages: 20 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 147
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Location: Hopital Pitie Salpetriere Paris Île-de-France Region
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?
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT01063608). StuddyBuddy aggregates publicly available trial information.