E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunisation against influenza disease in elderly population aged over 65 years (>65 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 evaluate the safety and reactogenicity of a revaccination with adjuvanted vaccine FluAS25 during 21 days following the intramuscular administration of the vaccine. Fluarix will be used as reference. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the humoral immune response (anti-haemagglutinin and anti-MPL titres) and cell mediated immune response (production of IFN-gamma, IL-2, CD40L, and TNF-alpha and B-memory cell response) 21 days after revaccination with adjuvanted influenza vaccine FluAS25. Fluarix will be used as reference. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
All subjects must satisfy the following criteria at study entry: 1. Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards) should be enrolled in the study. 2. Written informed consent obtained from the subject. 3. Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
In the FluAS25 group, all subjects must satisfy the following criteria at study entry: - A male or female aged over 65 years (> 65 years-old) at the time of the revaccination; who previously received AS25 adjuvanted influenza vaccine during the FLUAS25-001 clinical trial.
In the control group (Fluarix), all subjects must satisfy the following criteria at study entry: - A male or female aged over 65 years (> 65 years-old) at the time of revaccination; who previously received Fluarix™ during the FLUAS25-001 clinical trial.
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E.4 | Principal exclusion criteria |
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period. 2. 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, > or equal 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) 3. History of confirmed influenza infection since a year from the date of previous vaccination. 4. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 5. History of hypersensivity to vaccines. 6. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 7. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. 8. Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). 9. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms during a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after vaccination and overall. 2. Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during a 21 day follow-up period (i.e. day of vaccination and 20 subsequent days) after vaccination and overall. 3. Occurrence of serious adverse events during the entire study.
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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 | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
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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 | No |
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 | Information not present in EudraCT |
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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last visit of the last patient |
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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 | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 1 |