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

Phase 4

Completed

• Conditions: Influenza A Virus, H1N1 Subtype
• Interventions: Biological: Anti-H1N1v Vaccine

• Registration Number: NCT01063608
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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:

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2009-12
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Status Verified: 2010-03
• Study Completion: 2010-05
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anti-H1N1v Vaccine	Anti-H1N1v Vaccine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Hopital Pitie Salpetriere; 🇫🇷 Paris, Ile De France, France

Centre d'Investigations Cliniques (CIC), Hopital Cochin; 🇫🇷 Paris, Ile De France, France