E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
To demonstrate that vaccination with Enzira (2006/2007) produces an immune response sufficient to meet the Committee for Proprietary Medicinal Products (CPMP) criteria for Older Adults of >30% seroconversion and >60% seroprotection |
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E.2.2 | Secondary objectives of the trial |
1. To demonstrate that Enzira (2006/2007) is no more reactogenic than GlaxoSmithKline Influenza Vaccine (Fluarix or Influsplit) (2006/2007) in Healthy Older Adults aged >=65 years
2. To demonstrate that vaccination with Enzira (2006/2007) produces an immune response in Healthy Older Adults aged >= 65 years sufficient to meet the criteria of the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines in Older Adults
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. healthy adults aged >= 65 years at the time of informed consent 2. provides written informed consent and adherence to all protocol requirements 3. is in good health, as determined by medical history and physical examination where indicated 4. is able to understand and comply with planned study procedures
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E.4 | Principal exclusion criteria |
1. Hypersensitivity to eggs, chicken protein, neomycin, polymyxin, gentamicin sulphate, formaldehyde, sodium deoxycholate, thiomersal or any components of the Study Vaccines; 2. Interpandemic vaccination against influenza or laboratory culture confirmed Influenza in 2006; 3. Vaccination with an experimental influenza vaccine (eg. a candidate pandemic influenza vaccine or a novel influenza vaccine) in 2006; 4. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality; 5. Known history of Guillain-Barré Syndrome; 6. Clinical signs of active infection and/or an oral temperature of >= 38°C (100.4°F). Study entry may be deferred for such individuals, at the discretion of the Principal Investigator (PI); 7. Active neurological disease; 8. Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder; 9. Current treatment with warfarin or other anticoagulant; 10. Current (or within the 90 days prior to receiving the Study Vaccines) immunosuppressive or immunomodulative therapy, including systemic corticosteroids, as follows: · Chronic or long term corticosteroids: >15mg/day of oral prednisolone or equivalent daily; · Sporadic corticosteroids: >40mg/day of oral prednisolone or equivalent for more than two courses of >14 days in the three months preceding vaccination; · Administration of immunogobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine or during the study Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccines or throughout the Study is acceptable. 11. Participation in a clinical trial where the participant received an investigational product or use of an investigational compound (i.e. a new chemical or biological entity not registered for clinical use) within 30 days prior to receiving the Study Vaccines or plans to enter a clinical trial during the study period; 12. Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccines; 13. Current treatment, or treatment with cytotoxic drugs or radiotherapy at any time during the six months prior to administration of the Study Vaccines; 14. Major congenital defects or serious chronic illness; 15. Evidence, or history (within the previous 12 months) of drug or alcohol abuse; 16. Unwillingness or inability to comply with the study Protocol; 17. History of psychiatric disorders, which, in the opinion of the Principal Investigator (PI), would prevent participants from giving proper informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
Co-primary immunogenicity endpoints of seroprotection rate and seroconversion rate will be assessed. Seroprotection is defined as a minimum post vaccination haemagglutination inhibition (HI) titre of 1:40. Seroconversion is defined as an increase in Hi antibody titre of at least 4-fold, with a minimum post vaccination HI titre of 1:40 |
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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 | No |
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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
immunogenicity, tolerability |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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) | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
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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 | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 2 |