E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxis against flu virus 2008-2009. |
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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 | HLT |
E.1.2 | Classification code | 10022005 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022000 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022000 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022000 |
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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 |
To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in non-elderly adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of a single intramuscular (IM) injection of AGRIPPAL S1 in non-elderly adult and elderly subjects. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry; 2. able to comply with all the study requirements; 3. in general good health as determined by: - medical history; - physical examination; - clinical judgment of the investigator |
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E.4 | Principal exclusion criteria |
1. They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to: a. Cancer, except for localized skin cancer; b. Advanced congestive heart failure; c. Chronic obstructive pulmonary disease (COPD); d. Autoimmune disease (including rheumatoid arthritis); e. Acute or progressive hepatic disease; f. Acute or progressive renal disease; g. Severe neurological or psychiatric disorder; h. Severe asthma. 2. They have history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate); 3. They have a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from: - receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; - receipt of immunostimulants; - receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; - suspected or known HIV infection or HIV-related disease; 4. They have a known or suspected history of drug or alcohol abuse; 5. They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigators opinion would interfere with the safety of the subject; 6. Women who are pregnant, 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 8. Within the past 6 months, they have: - had laboratory confirmed influenza disease; - received influenza vaccine; 9. Within the past 4 weeks they have received: - another vaccine; - any investigational agent; 10. They have any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days; 11. They have experienced an acute exacerbation of a COPD within the past 14 days; 12. They have experienced fever (i.e., axillary temperature≥ 38C) within the last 3 days; 13. They are taking part in another clinical study; 14. They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives; 15. They are severely obese with Body Mass Index (BMI) > 35; |
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E.5 End points |
E.5.1 | Primary end point(s) |
- The proportion of subjects achieving seroconversion or significant increase in anti-HA antibody titer should be > 40% - Mean geometric increase should be > 2.5 - The proportion of subjects achieving an HI titer ≥ 40 or SRH area ≥ 25 mm2 should be > 70% The following serological assessments should be considered for each strain in elderly subjects, aged over 60, and at least one of the assessments should meet the indicated requirements: - The proportion of subjects achieving seroconversion or significant increase in anti-HA antibody titer should be > 30% - Mean geometric increase should be > 2.0 - The proportion of subjects achieving an HI titer ≥ 40 or SRH area ≥ 25 mm2 should be > 60% |
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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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | 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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 0 |
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 | 0 |