E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy subjects, Immunization against influenza in male and female subjects aged ≥ 50 years. |
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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 immune response induced by FluAS25 in elderly adults is superior to that induced by Fluarix, 21 days following vaccination for each vaccine strain.
•To demonstrate that the immune response induced by the FluAS25 in subjects aged between 50 and 64 years is superior to the one induced by Fluarix, 21 days following vaccination for each vaccine strain.
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E.2.2 | Secondary objectives of the trial |
•To evaluate in all subjects, the safety and reactogenicity of one dose of FluAS25 and Fluarix •To demonstrate that the immune response induced by the FluAS25 in elderly adults is non-inferior to the one induced by Fluarix in young adults, 21 days following vaccination for at least 2 of the 3 vaccine strains. •To evaluate the immunogenicity of FluAS25 and Fluarix, 21 and 180 days following vaccination, in all subjects. •To demonstrate, in a subset of subjects aged ≥ 65 years and in subjects aged 50-64 years, that the CMI response in terms of frequency of influenza-specific CD4 T lymphocytes producing at least two different cytokines induced by the FluAS25 is superior to the one induced by Fluarix, 21 days following vaccination. •To evaluate in a subset of subjects, the CMI response induced by the study vaccines in terms of frequency of influenza-specific CD4 T lymphocytes at Day 0, 21 and 180.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). • A male or female aged between 18 and 40 years or aged 50 years or older at the time of the vaccination. • Written informed consent obtained from the subject. • Free of an acute aggravation of the health status as established by clinical examination before entering into the study. •If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.
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E.4 | Principal exclusion criteria |
• Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination. • Planned administration of an influenza vaccine other than the study vaccines during the entire study period. •Previous vaccination against influenza (2006-2007 influenza vaccine). •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). •History of hypersensivity to a previous dose of influenza vaccine. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, gelatin, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate. •Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests. •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F)). •Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study. •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period. •Any medical conditions in which IM injections are contraindicated
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E.5 End points |
E.5.1 | Primary end point(s) |
Observed variable • At days 0 and 21, serum haemagglutination-inhibition (HI) antibody titer, against each of the three vaccine strains, in the following age groups: 50-64 years and >/= 65 years Derived variables: - Geometric mean titers (GMTs) of HI antibody titers at days 0 and 21 - Seroconversion rates at day 21 defined as the percentage of vaccinees who have either a prevaccination titer < 1:10 and a post-vaccination titer >/= 1:40 or a pre-vaccination titer >/= 1:10 and at least a four-fold increase in post-vaccination titer.
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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 | No |
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 | 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 |
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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) | Yes |
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 | No |
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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 58 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |