E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
prevention, vaccination against Influenza in subjects 65 years or older via intradermal route |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016794 |
E.1.2 | Term | Flu vaccination |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity Anti-Hemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
comparison of application routes, intradermal vs. intramuscular |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |