Influenza, Myxovirus Infection, Orthomyxovirus Infections
Conditions
Keywords
Influenza, Orthomyxoviruses, Myxovirus Infection, Inactivated Split-virion influenza vaccine, Adults, Elderly
Brief summary
To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations. Objectives: * To describe the immune response per age group and vaccine group after vaccination. * To describe the safety of the vaccines per age group and per vaccine group after vaccination.
Interventions
BIOLOGICALInactivated, split-virion, influenza vaccine
0.1 mL, Intradermal
0.1 mL, Intradermal
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
: * Aged 18 to 40 years (adults) or 60 to 85 years (elderly) * Provision of a signed informed consent * Able to attend all scheduled visits and comply with all trial procedures * 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 * Entitlement to national social security.
Exclusion criteria
: * For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test * Breast-feeding woman * Participation in another clinical trial investigating a vaccine, drug, medical device or a medical procedure in the 4 weeks preceding the trial vaccination * Planned participation in another clinical trial during the present trial period * 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 * 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 * Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator * Current alcohol abuse or drug addiction, which may interfere with the subject's ability to comply with trial procedures * Receipt of blood or blood-derived products in the past 3 months, which might interfere with the assessment of immune response * Receipt of any vaccine in the 4 weeks preceding the trial vaccination * Planned receipt of any vaccine in the 4 weeks following the trial vaccination * Known Human Immunodeficiency Virus, Hepatitis B or Hepatitis C seropositivity * Previous vaccination against Influenza in the previous 6 months * Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding the inclusion contraindicating IM vaccination * Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent * 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 |
|---|---|
| To provide information concerning immune response to an inactivated, split-virion, influenza vaccine. | 21 days post-vaccination |
| To provide information concerning the safety of inactivated, split-virion, influenza vaccine. | 21 days post-vaccination and entire study duration |
Countries
France
Outcome results
None listed