E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxsis of seasonal influenza |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10022005 |
E.1.2 | Term | Influenza viral infections |
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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 demonstrate in elderly subjects (> 61 years of age) that three weeks after the first vaccination the cell-derived influenza vaccine meets all three of the Committee for Medicinal Products for Human Use (CHMP) criteria for influenza vaccine immunogenicity for the three strains in the vaccine.
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E.2.2 | Secondary objectives of the trial |
1) To assess in the elderly subjects one year following the initial vaccination, whether three weeks after revaccination with the cell-derived influenza vaccine all three CHMP criteria for influenza vaccine immunogenicity are met for all three strains in the vaccine. 2) To assess in elderly subjects during the first year the long-term immunogenicity of the cell-derived influenza vaccine six months following the initial vaccination. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Female or male subjects > 61 years of age. 2. Willing and able to give informed consent before any protocol procedures are performed. 3. Able to adhere to visit schedules and all protocol required study procedures. 4. Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been unchanged for at least 3 months preceding study vaccination). |
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E.4 | Principal exclusion criteria |
1. Seasonal influenza vaccination or laboratory confirmed seasonal influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination (seasonal or novel Influenza A (H1N1)) within three weeks of study vaccination. 2. Presence of any significant condition that may prohibit inclusion as determined by the Investigator. 3. A serious adverse reaction after a previous vaccination, including influenza vaccination. 4. A history of Guillain-Barré syndrome. 5. Known to be allergic to constituents of the study vaccines. 6. Fever and/or presence of an acute infectious episode of the upper and/or lower respiratory airways. Fever is defined as an oral temperature of ≥ 38ºC. Enrollment can be postponed until a subject has been a febrile for 72 hours. 7. Being a solid organ or bone marrow/stem cell transplant recipient. 8. Use of immune system modulators including: systemic corticosteroids, immunosuppressive agents such as cyclosporine, intravenous monoclonal antibodies and intravenous or intramuscular gamma-globulin preparations within four weeks of study vaccination or if planned for use any time during the study. Topical use of corticosteroids (e.g. cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the package insert, is allowed. 9. Chronic diseases requiring long-term immunosuppressive therapy. 10. Receipt of another investigational product within 90 days prior to entering this study (date of informed consent), participating in the long-term follow-up of another clinical trial, unwilling to refuse to participate in another clinical trial during the current clinical study. 11. Known drug or alcohol abuse. 12. Blood or plasma transfusions received within three months of study vaccination. 13. Vaccination with a live vaccine or a killed/inactivated vaccine in the four weeks prior to study vaccination. 14. Being an employee of the Sponsor/CRO conducting this study or personnel of the study site. 15. During the second year of the study only: History of vaccination with a seasonal influenza vaccine following initial study vaccination on studies Day 1 (Visit 1). |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary immunogenicity endpoints will be the serum haemagglutination inhibition antibody (HI) titers measured the same day as but prior to vaccination as well as three weeks after vaccination. From these measurements, seroprotection rates, seroconversion rates, and mean fold increases will be derived. In addition, HI titers are to be measured six months after the initial vaccination. |
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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 | 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 | Yes |
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 |
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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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |