E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vaccination of adults subjects aged 50 to 59 years with inactivated, split-virion influenza vaccine administered by the intradermal route using Vaxigrip® as IM reference vaccine. |
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MedDRA Classification |
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 |
• To demonstrate that the ID investigational vaccine is at least as immunogenic as the IM reference vaccine in terms of geometric mean titer (GMT) after vaccination.
• If non-inferiority is demonstrated, to demonstrate that the ID investigational vaccine induces a better immunogenicity than the IM reference vaccine in terms of seroprotection rate after vaccination.
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E.2.2 | Secondary objectives of the trial |
Immunogenicity: -To describe the immunogenicity of the ID investigational vaccine after vaccination using parameters defined in the 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 solicited systemic reactions. -To describe the safety profile after vaccination. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Aged 50 (from the 50th birthday) to 59 years old (day before the 60th birthday) 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 of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) observed for at least 4 weeks prior to the vaccination and at least 4 weeks after the vaccination.
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E.4 | Principal exclusion criteria |
1) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test. 2) Breast-feeding woman. 3) 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. 4) Febrile illness, i.e. oral temperature ≥ 37.5°C (>37.0°C for Czech) or rectal equivalent temperature ≥38.0°C (>37.5°C for Czech), on the day of inclusion. 5) Participation in another clinical trial in the 4 weeks preceding the trial vaccination. 6) Planned participation in another clinical trial during the present trial period. 7) 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. 8) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. 9) Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures. 10) Receipt of blood or blood-derived products in the past 3 months. 11) Any vaccine in the 4 weeks preceding the trial vaccination. 12) Planned receipt of any vaccine in the 4 weeks following the trial vaccination. 13) Previous vaccination against seasonal or pandemic influenza (in the previous 6 months). 14) Previous vaccination with inactivated, split-virion influenza vaccine administered by intradermal route. 15) Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. 16) Known Human Immunodeficiency Virus (HIV), HBs antigen or Hepatitis C seropositivity. 17) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Hemagglutinin inhibition (HI) antibody titers for the three strains, 21 days (D21) after vaccination. - Seroprotection status: HI antibody individual titer ≥ 40 (1/dil), 21 days (D21) 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 | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 |
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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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
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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End of trial is defined as the date of the last contact with a trial subject within the scope of the trial in the last country. |
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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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 15 |