Vaccination of adults aged 18 to 60 years 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 18 to 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 4) For a woman, inability to bear a child or negative urine pregnancy test at the first visit (V0) 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) no 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 octoxinol 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 4 weeks preceding the 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 trial vaccination 10) Vaccination planned in the 4 weeks following the trial vaccination 11) Previous vaccination against influenza (in the previous 6 months) 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 three different industrial lots of the intradermal (ID) investigational vaccine induce an equivalent immune response.;Secondary Objective: Immunogenicity: - To demonstrate that the ID investigational vaccine induces an immune response at least as good as the one induced by the intramuscular (IM) reference vaccine, in terms of antibody titers. - To assess the immunogenicity of the ID investigational vaccine using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96). Safety: - To demonstrate that the ID investigational vaccine is at least as well tolerated as the IM reference vaccine, in terms of proportions of subjects with any moderate or severe systemic solicited reaction. - To describe the safety profile after vaccination. Comfort of the vaccination assessment: - To assess the pain immediately after the injection using a Verbal Rating Scale (VRS). - To describe the vaccination comfort after the injection (via the ID and IM routes) using a - Patient-Reported Outcome questionnaire: the Vaccination Comfort Questionnaire (VCQ).;Primary end point(s): For each lot, anti-hemagglutinin (HA) antibody titers for the three strains 21 days (D21) after vaccination. | — |
Countries
Lithuania, Spain, United Kingdom
Outcome results
None listed