E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active influenza profilaxis pandemic strain |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022000 |
E.1.2 | Term | Influenza |
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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 cell-mediated immunity frequency and functionality of Ag-specific T and B lymphocytes after one, two and three 0.5 mL intramuscular IM injections of two FLUAD-like influenza vaccines containing either 7.5 mg or 15 mg of A/H5N1 influenza antigen and of a non-adjuvanted influenza vaccine containing 15 mg of A/H5N1 influenza antigen. To evaluate immunogenicity after one, two and three 0.5 mL IM injections of two FLUAD-like influenza vaccines containing either 7.5 mg or 15 mg of A/H5N1 influenza antigen and of a non-adjuvanted influenza vaccine containing 15 mg of A/H5N1 influenza antigen, as measured by hemagglutination inhibition HI , microneutralization MN and single radial hemolysis SRH assay. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of the administration of three 0.5 mL IM injections of two FLUAD-like influenza vaccines containing either 7.5 mg or 15 mg of A/H5N1 influenza antigen and of a non-adjuvanted influenza vaccine containing 15 mg of A/H5N1 influenza antigen. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
18 to 60 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.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 |
they have any serious disease such as cancer 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 complicated 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. they are hypersensitive to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamicin or any other component of the vaccine; 3. they have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine 4. 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 suspected or known HIV infection or HIV-related disease 5.women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial 382 days ; 6.within the past 4 weeks they have received another vaccine any investigational agent 7.within the past 7 days, they have experienced any acute disease infections requiring systemic antibiotic or antiviral therapy chronic antibiotic therapy for urinary tract prophylaxis is acceptable 8.within the past 3 days, they have experienced fever i.e., axillary temperature 8805; 38 C ; 9.they are taking part in another clinical study; 10.they have surgery planned during the study period 11.they have any anemia, hypotension or any other medical condition which at the investigator s discretion could constitute a contraindication to the blood sampling foreseen by the study protocol 12.they have any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective. |
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E.5 End points |
E.5.1 | Primary end point(s) |
interpretation immunogenicity results according to CPMP Nfg criteria CPMP/BWP/214/96 |
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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 | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | 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 |
stesso farmaco senza adiuvante |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
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 | 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 | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |