E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
immunization against influenza of healthy adults |
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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 humoral response (anti-haemagglutinin antibody tested by haemagglutination inhibition) against each vaccine strain in adults aged 18 years or above 21 days after vaccination with Fluarix™/Influspit SSW® 2006/2007. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety/reactogenicity of Fluarix™/Influspit SSW® 2006/2007 in adults aged 18 years or above, in terms of: • solicited local/general symptoms during 4 days post-vaccination • unsolicited symptoms during 30 days post-vaccination • serious adverse events during 30 days post-vaccination
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. • A male or female aged 18 years or above at the time of the vaccination. • Written informed consent obtained from the subject. • Healthy subjects or with well-stabilized chronic diseases as established by medical history and clinical examination before entering into the study. • If the subject is female, she must be of non-childbearing potential |
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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 vaccination 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 first vaccine dose. • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study. • Administration of an influenza vaccine within 6 months preceding the study start • Administration of an influenza vaccine other than the study vaccine during the entire study • Confirmed influenza infection within 6 months preceding the study start • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. • Acute disease at the time of enrolment. • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. • Not stabilized or clinically serious chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insuline-dependent diabetes Mellitus) • Lactating female. • History of chronic alcohol consumption and/or drug abuse. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • 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) |
Evaluation of the humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains: the following parameters will be calculated with 95% confidence intervals:
• Geometric mean titers (GMTs) of anti-HA antibody titers at days 0 and 21 • Seroconversion rates* at day 21 • Seroconversion factors** at day 21 • Seroprotection rates*** at days 0 and 21 • Seroprotection power**** at day 21
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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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
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 years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 1 |