prevention, vaccination against Influenza in subjects 65 years or older via intradermal route MedDRA version: 9.1 Level: LLT Classification code 10016794 Term: Flu vaccination
Conditions
Sponsors
Sanofi Pasteur MSD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged 65 years or older on the day of inclusion Informed consent form signed Able to attend all scheduled visits and to comply with all study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: Febrile illness (oral temperature =37.5°C) on the day of inclusion 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 adverse reaction to the study vaccine or a vaccine containing the same substances Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination Unstable chronic illness (defined as illness requiring hospitalisation or a clinically significant change in medication in the past 12 weeks) at a stage that could interfere with study conduct or completion Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy, or radiation therapy in the past 6 months, or long-term systemic corticosteroids therapy given daily or on alternate days at =20 mg/day prednisone equivalent for 14 days or more Any blood or blood-derived product (including immunoglobulins) in the past 3 months Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with study procedures Any vaccination in the past 4 weeks Any vaccination planned in the 4 weeks following study vaccination Any vaccination against influenza in the past 6 months (with the study vaccine or another vaccine) Subjects who previously received a vaccination against influenza by intradermal route Participation in another clinical study in the past 4 weeks Planned participation in another clinical study during the present study period Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised without his/her consent or subject under guardianship, or subject in a social or sanitary establishment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity To demonstrate that the influenza vaccine administered by intradermal (ID) route at the dose of 15µg is at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular (IM) route at the same dosage in term of HA antibody titres for the three strains at Day 21 post-vaccination. ;Secondary Objective: Immunogenicity To describe the immune response 21 days after vaccination with the influenza vaccine administered by ID route at the dose of 15µg versus the adjuvanted influenza vaccine administered at the same dose by IM route for each strain in terms of: GMTR (Geometric Mean of individual post/pre-antibody Titres Ratio) Post-vaccination seroprotection rate Seroconversion and/or significant increase rate To describe the compliance of both vaccines administered with the EMEA Note for Guidance immunogenicity criteria, specific for elderly subjects (CPMP/BWP/214/96) Safety: To describe the safety profile after vaccination in each group Acceptability To describe the pain at the injection site with a Verbal Rating Scale To describe the comfort of the injection using a questionnaire with a Vaccination Comfort Questionnaire ;Primary end point(s): Immunogenicity Anti-Hemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination. | — |
Countries
Belgium, France
Outcome results
None listed