E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The Flu vaccine is used for active prophilaxisys for the influenza, in subjects with chronic diseases (Hypertension, cardiopatie, BOCD, asthma,renal or hepatic insufficiency, arteriosclerosis and diabetes insulindependent) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059429 |
E.1.2 | Term | Influenza immunisation |
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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 |
Immunogenicity Objectives To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-vaccination in at risk adult subjects in compliance with the requirements of the current EU recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96). Safety Objectives To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD in at risk adult subjects.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
18-64- years of age, mentally competent, willing and able to give written informed consent prior to study entry; 2. able to comply with all the study requirements; 3. suffering from at least one of the following chronic diseases: · hypertension · hearth diseases · chronic obstructive pulmonary disease (COPD) or asthma hepatic or renal insufficiency · arteriosclerotic disease or insulin dependent diabetes mellitus
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E.4 | Principal exclusion criteria |
Individuals are not to be enrolled into the study if: 1. they are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate or any other component of the vaccine; 2. they have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine; 3. they have a known or suspected (or have a high risk of developing) impairment/ alteration of immune function resulting, for example, from: · receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and/or for the full length of the study; · suspected or known HIV infection or HIV-related disease women who are pregnant, or women who are breast-feeding, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days); 7. within the past 12 months, they have: · received more than one injection of influenza vaccine; |
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E.5 End points |
E.5.1 | Primary end point(s) |
The measures of immunogenicity for each antigen are:
- the geometric mean area (GMA) on Day 0 and Day 21
- the Day 21/Day 0 geometric mean area ratio (GMR)
- the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2
- the percentage of subjects achieving an SRH area >= 25 mm2 on Day 0 and 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 | Yes |
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 | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | No |
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 | No |
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 |