E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunization against influenza disease during pandemic in subjects over 60 years of age. |
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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 immunogenicity of the H5N1vaccine administered as a single or double dose in terms of humoral immune response 21 days after the first and second vaccination (for anti-haemagglutinin antibody response) and 21 days after the second vaccination (for neutralizing antibody response). •To assess the persistence of antibodies 180 days, one year and two years after the first vaccination with the H5N1 vaccine.
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E.2.2 | Secondary objectives of the trial |
•To evaluate the safety/reactogenicity of the H5N1 vaccine administered as a single or double-dose in terms of: - 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 each dose of vaccine and overall. - Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during 21 days following the first vaccination (i.e. Day of first vaccination and 20 subsequent days) and during 30 days following the second vaccination (i.e. Day of second vaccination and 29 subsequent days). - Occurrence of serious adverse events during the entire study period. •To evaluate at days 0, 21, 42 and 180 for all subjects and in addition, Year 1 and Year 2 for subjects in Belgium, the CMI response in terms of Th1-specific activation marker expression.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. •A male or female aged 61 years or above at the time of the first vaccination. •Written informed consent obtained from the subject. •Healthy subjects or subjects with well controlled underlying disease.
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E.4 | Principal exclusion criteria |
Administration of the licensed MF59-containing vaccines, e.g. Fluad or Addigrip or virosome-based influenza vaccines such as Inflexal V, InfectoVac Flu or Invivac.
•Administration of 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 the second vaccination with H5N1 vaccine. •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). •History of chronic alcohol consumption and/or drug abuse. •History of hypersensitivity to vaccines. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (including egg and thiomersal allergy). •Acute 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. •Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included, as well as subjects with well controlled underlying diseases). •Administration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or 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 the first vaccination, or planned use during the study period. •Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
For the humoral immune response in terms of anti-HA antibodies, the following parameters (with 95% confidence intervals [CIs]) will be calculated for each group: •Geometric mean titres (GMTs) of H5N1 antibody titres at days 0, 21, 42 and 180 for all subjects and in addition, Month 12 and Month 24 for subjects in Belgium. •Seroconversion rates (SCR) at days 21, 42 and 180 for all subjects and in addition, Month 12 and Month 24 for subjects in Belgium. •Seroconversion factors at days 21, 42 and 180 for all subjects and in addition, Month 12 and Month 24 for subjects in Belgium. •Seroprotection rates at days 0, 21, 42 and 180 for all subjects and in addition, Month 12 and Month 24 for subjects in Belgium. In addition, humoral immune response in terms of neutralizing antibodies will be evaluated in a subset of subjects in the adjuvanted groups using the following parameters (with 95% CIs): •Geometric mean titres (GMTs) of H5N1 antibody titres at days 0, 42 and 180 and in addition, Month 12 and Month 24 for subjects in Belgium. •Seroconversion rates (SC) at days 42 and 180 and in addition, Month 12 and Month 24 for subjects in Belgium.
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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 | Yes |
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) | 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 | 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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
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
| 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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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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last visit of last subject |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |