E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunisation against influenza disease in an elderly population aged over 65 years |
|
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 repeated vaccination with FluAS25, during 21 days following the intramuscular administration of the vaccine. Fluarix will be used as reference |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the humoral immune response (anti-haemagglutinin antibody titres), cell-mediated immune response (production of IFN, IL-2, CD40L, and TNF) and anti-MPL antibody titres 21 days after revaccination with FluAS25. Fluarix will be used as reference. |
|
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 should be enrolled in the study. - Written informed consent obtained from the subject. - Healthy subjects as established by medical history and 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 67 years or above at the time of the revaccination, who previously received FluAS25 during the FluAS25-002 clinical trial.
In the Fluarix groups, all subjects must satisfy the following criteria at study entry:
- A male or female aged over 65 years at the time of revaccination; who previously received Fluarix during the FluAS25-002 clinical trial.
|
|
E.4 | Principal exclusion criteria |
- 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. - 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). - History of confirmed influenza infection since the date of previous vaccination. - 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 including egg, chicken protein, formaldehyde, thiomersal, gentamicin sulfate or sodium deoxycholate. - Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. - Acute disease at the time of enrolment. - Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
- 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. - 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. - Occurrence of serious adverse events during the entire study period
|
|
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 |
|
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) | 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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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
|
|
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 | 2 |
E.8.9.1 | In the Member State concerned days | |