Vaccination of elderly subjects aged 60 years and over with inactivated, split-virion influenza vaccine administered by the intradermal route using Vaxigrip® as IM reference vaccine.
Conditions
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged over 60 years on the day of inclusion 2) Informed Consent Form signed 3) Able to attend all scheduled visits and to comply with all trial procedures 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) Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxynol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances 2) Febrile illness (oral temperature = 37.5°C or rectal equivalent temperature = 38.0°C) on the day of inclusion 3) Participation in another clinical trial in the four weeks preceding the first trial vaccination 4) Planned participation in another clinical trial during the present trial period 5) 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) Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the 12 weeks prior to inclusion) at a stage that could interfere with trial conduct or completion 7) Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures 8) Blood or blood-derived products received in the past 3 months 9) Any vaccination in the 4 weeks preceding the first trial vaccination 10) Vaccination planned in the 4 weeks following the first trial vaccination 11) Previous vaccination against influenza (in the previous 6 months) with the trial vaccine or another vaccine 12) Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination 13) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the intradermal (ID) investigational vaccine induces a better immunogenicity than the intramuscular (IM) reference vaccine in terms of seroprotection rate after the first vaccination;Secondary Objective: Immunogenicity: -To describe the antibody persistence induced by both vaccines at 3, 6 and 12 months after the 1st vaccination in a subset of subjects. -To describe the immunogenicity of the ID investigational vaccine after each vaccination using parameters defined in the EMEA Note for Guidance (CPMP/BWP/214/96) specific to elderly subjects. Safety: -To demonstrate that the ID investigational vaccine is at least as well tolerated as the IM reference vaccine after the first vaccination, in terms of proportions of subjects with any moderate or severe solicited systemic reaction. -To describe the safety profile after each vaccination. -To describe the effect of repetitive ID injections on the safety profile. Comfort of the vaccination assessment;Primary end point(s): - Anti-hemagglutinin (HA) antibody titers for the three strains, 21 days (D21) after the first vaccination. - Seroprotection status: anti-HA antibody individual titer = 40 (1/dil), 21 days (D21) after the first vaccination. | — |
Countries
Belgium, Italy, Lithuania
Outcome results
None listed