Vaccination of adult subjects aged 18 to 40 years and elderly subjects aged 60 to 85 years with an inactivated, split-virion influenza vaccine administered via the intradermal route using Vaxigrip® as IM reference vaccine
Conditions
Interventions
Product Name: Intradermal Influenza Vaccine
Product Code: 333
Pharmaceutical Form: Suspension for injection
Other descriptive name: Inactivated, split-virion, influenza virus (H3N2 strain)
Concentrati
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 40 years (adults) or 60 to 85 years (elderly) 2) Provision of a signed informed consent 3) Able to attend all scheduled visits and comply with all trial procedures 4) For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until 4 weeks after vaccination 5) Entitlement to national social security Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test 2) Breast-feeding woman 3) Participation in another clinical trial investigating a vaccine, drug, medical device or a medical procedure in the 4 weeks preceding the trial vaccination 4) Planned participation in another clinical trial during the present trial period 5) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy 6) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances 7) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator 8) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures 9) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response 10) Receipt of any vaccine in the 4 weeks preceding the trial vaccination 11) Planned receipt of any vaccine in the 4 weeks following the trial vaccination 12) Known Human Immunodeficiency Virus, Hepatitis B or Hepatitis C seropositivity 13) Previous vaccination against Influenza in the previous 6 months 14) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding the inclusion contraindicating IM vaccination 15) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent 16) Febrile illness (oral temperature =37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Cellular Immune Response - Intracellular Cytokine Staining (ICS): -- To quantify the number of Interferon- ? (INF-?), Interleukine-2 (IL-2) or Tumor necrosis factor- a (TNF-a) secreting CD4+ and CD8+ T lymphocytes after stimulation with influenza live virus (for each vaccine strain) in all the subjects at D0, D7, D10, D14, D21 and D180 -- To quantify the number of influenza-specific CD4+ and CD8+ T lymphocytes displaying a memory profile (IL-2 secreting cells [IL-2+]) in all the subjects at D0, D7, D10, D14, D21 and D180 -- To quantify the number of influenza-specific CD4+ and CD8+ T lymphocytes exhibiting an effector profile (INF-? and TNF-a secreting cells [INF-?+ and TNF-a+]) in all the subjects at D0, D7, D10, D14, D21 and D180 - Cytometric Bead Array (CBA): -- To measure the concentration of a panel of Th1 (IFN-?, TNF-a, IL-2), and Th2 (IL-5, IL-4, IL 10) cytokines secreted by peripheral blood mononuclear cells (PBMCs) upon in vitro re stimulation with the three influenza vaccine strains in all the subjects at D0 and at the peak of the cellular response measured by ICS (D7 or D10 or D14 or D21 or D180) - Lymphoproliferation: -- To quantify the specific lymphoproliferative response (measured by 3H-thymidine incorporated in cells and expressed in counts per minute [cpm]), upon in vitro re-stimulation of PBMCs (= Stimulation Index [SI]) with influenza antigens from the three vaccine strains in all the subjects at D0 and at the peak of the cellular response measured by ICS (D7 or D10 or D14 or D21 or D180) Depending on the results obtained with ICS method, CBA and lymphoproliferation assessments will not be performed at each timepoint: if a peak of response is clearly identified for one of the timepoints tested, CBA and lymphoproliferatrion methods will be performed at this timepoint only. If no peak of response emerged, CBA and lymphoproliferatrion method will be performed at the most relevant timepoint obtained according to results and li | — |
Countries
France
Outcome results
None listed