E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
no medical condition; healthy volunteers will be recruited into clinical trial for annual approval of Influenza vaccine with new strain composition according to WHO and EMEA recommendation and CPMP criteria (Note for Guidance on Harmonisation of Requirements for Influenza Vaccines, 12 March 1997, CPMP/BWP/214/96), Influenza vaccine for prevention of Influenza |
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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 |
Immunogenicity Objectives: To evaluate the antibody response to each influenza vaccine antigen, as measured by Haemagglutination Inhibition (HI) Test on Day 0 and on Day 21, i.e., 21 days after vaccination in non-elderly 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 |
Safety Objectives: To evaluate safety of a single IM dose of the split influenza vaccine Begrivac in non-elderly 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 |
Subjects eligible for enrollment into this study are male and female adults who are 1. ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry 2. available for all the visits scheduled in the study and able to comply with all study requirements 3. in good health as determined by: medical history, physical examination, clinical judgment of the investigator Informed consent must be obtained from all the subjects before enrollment in the study after the nature of the study has been explained.
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E.4 | Principal exclusion criteria |
Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled: 1. They have any serious chronic disease such as: a. cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin cancer and non metastatic prostate cancer not presently treated with chemotherapy b. congestive heart failure c. advanced arteriosclerotic disease d. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy e. autoimmune disease (including rheumatoid arthritis) f. insulin dependent diabetes mellitus g. acute or progressive hepatic disease h. acute or progressive renal disease 2. They have a history of any anaphylaxis, serious vaccine reactions, are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin 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: a. receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the last 2 months and for the full length of the study, b. receipt of immunostimulants, c. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study, d. suspected or known HIV infection or HIV-related disease. 5. They have a known or suspected history of drug or alcohol abuse. 6. They have a bleeding diathesis or receive anticoagulants of the coumarin type. 7. Women who are pregnant or who could become pregnant during the study but are not willing to practice acceptable contraception for the duration of the study (21 days). 8. within the past 12 months, they have received more than one injection of influenza vaccine 9. Within the last 6 months they have a. had laboratory confirmed influenza disease b. have been vaccinated against influenza 10. Within the last 4 weeks they have received a. another vaccine b. any investigational agent 11. They have experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days. 12. They have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the last 14 days. 13. They have experienced fever (i.e. body temperature ≥ 38.0°C) within the past 3 days. 14. They are taking part in another clinical study. 15. They have any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity with respect to specific antibody titers to each influenza strain measured by Haemagglutination Inhibition (HI) Test on Day 0 and on Day 21, i.e., 21 days after vaccination. Safety Measurements: Subjects will be observed for 30 minutes for any immediate reactions. All subjects will be instructed to fill in a diary card for three days following immunization to collect local (pain at the injection site, erythema, ecchymosis, swelling and induration) and systemic (fever [i.e., axillary temperature ≥ 38°C], chills/shivering, malaise, headache, myalgia, arthralgia, sweating and fatigue) reactions. All adverse events will be collected during Day 0 to 3. All serious adverse events and/or adverse events necessitating a physician’s visit and/or resulting in premature subject’s withdrawal from the study will be collected throughout the study. |
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | |
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 months | 1 |