E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active influenza immunoprofilaxis |
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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 |
To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-vaccination in non-elderly adult and elderly 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). |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of the administration 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 | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Adult volunteers who are: 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: (i)medical history; (ii)physical examination; clinical judgment of the investigator
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E.4 | Principal exclusion criteria |
1. subjects who have any serious disease such as: · cancer (leukemia, lymphomas, neoplasm) except for benign or localized skin cancer and non metastatic prostate cancer not presently treated with chemotherapy; · autoimmune disease (including rheumatoid arthritis); · advanced arteriosclerotic disease or insulin dependent diabetes mellitus; · chronic obstructive pulmonary disease (COPD) that requires oxygen therapy; · acute or progressive hepatic disease; · acute or progressive renal disease; · congestive heart failure; 2. who are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate or any other component of the vaccine; 3. who have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine; 4. who 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 cortical steroid 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; 5. who have a known or suspected history of drug or alcohol abuse; 6. who have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator’s opinion would interfere with the safety of the subject; 7. 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); 8. who, within the past 12 months, have: · received more than one injection of influenza vaccine; 9. who, within the past 6 months, have: · had laboratory confirmed influenza disease; · received influenza vaccine; 10. who, within the past 4 weeks have received: · another vaccine; · any investigational agent; 11. who, within the past 7 days, have experienced: · any acute disease; · infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable); 12. who have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days; 13. who, within the past 3 days have experienced: · fever (i.e., axillary temperature ≥ 38°C); 14. who are taking part in another clinical study; 15. who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective. 16. Women who are breast feeding.
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E.5 End points |
E.5.1 | Primary end point(s) |
At least one of the following assessments should meet the indicated requirements for each strain: · Non-elderly adult subjects 18-60 years (i.e., ³ 18 and < 61) - number of seroconversions1 or significant increase in antibody titer2 > 40% - mean geometric increase > 2.5 - the proportion of subjects achieving an SRH area ³ 25 mm2 should be > 70%· · Elderly subject 61 years and over (i.e., ³ 61) - number of seroconversions1 or significant increase in antibody titer2 > 30% - mean geometric increase > 2.0 - the proportion of subjects achieving an SRH area ³ 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 | 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 | No |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 |