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 evaluate the immunogenicity of Enzira® vaccine in healthy ‘Adults’ aged ≥ 18 to < 60 years of age and in healthy ‘Older Adults’ aged ≥ 60 years of age according to the criteria of the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of Enzira® vaccine in healthy ‘Adults’ aged ≥ 18 to < 60 years of age and in healthy ‘Older Adults’ aged ≥ 60 years of age through:
1. The assessment of the frequency of solicited local reactions and general symptoms for 3 days following vaccination. 2. The assessment of unsolicited adverse events (AEs) of more than 2 days duration.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Healthy males or females, aged ≥ 18 years at the time of providing informed consent. 2. Provision of written informed consent to participate in the study and willingness to adhere to all Protocol requirements. 3. Be able to provide a sample of up to 20 mL of venous blood on two separate occasions without undue distress/discomfort. 4. Negative pregnancy test at enrolment before receiving Study Vaccine (female participants of child-bearing potential ONLY). Those at risk of pregnancy during the study period must, in the opinion of the Investigator, be taking/using adequate methods of contraception. Adequate methods are defined as: • Oral contraception • Intrauterine contraceptive device • Depot contraceptive (implants/injectables) • Abstinence • Partner Vasectomy • Condoms with spermicide.
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E.4 | Principal exclusion criteria |
1. Hypersensitivity to eggs, chicken protein, neomycin, polymyxin, or any components of the vaccine. 2. Vaccination against influenza within the previous 6 months. 3. Clinical signs of active infection and/or an oral temperature of ≥ 38oC at study entry. Study entry may be deferred for such individuals, at the discretion of the PI/delegate. 4. Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder. 5. Current (or within the 90 days prior to receiving the Study Vaccine) immunosuppressive or immunomodulative therapy, including systemic corticosteroids, as follows: • Chronic or long-term corticosteroids: ≥ 15 mg/day of oral prednisolone or equivalent daily. • Sporadic corticosteroids: ≥ 40 mg/day of oral prednisolone or equivalent for two or more short courses of > 3 days in the three months preceding vaccination. Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable. 6. Participation in a clinical trial or use of an investigational compound (i.e. a new chemical or biological entity not registered for clinical use) within 90 days prior to receiving the Study Vaccine or plans to enter a study during the study period. 7. Vaccination with any registered vaccine within 30 days prior to receiving the Study Vaccine. 8. Current treatment, or treatment with cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine. 9. Known history of Guillain-Barré Syndrome. 10. Active neurological disease. 11. Current treatment with warfarin or other anticoagulant; 12. Physical/Medical history that the Investigator feels may adversely affect the participant or study results. 13. Evidence, or history (within the previous 12 months) of drug or alcohol abuse. 14. Unwillingness or inability to comply with the study Protocol. 15. History of psychiatric disorders, which, in the opinion of the Principal Investigator, would prevent the participant from giving proper informed consent.
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E.5 End points |
E.5.1 | Primary end point(s) |
To meet at least one of the three immunogenicity criteria, applicable for each strain, as defined in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. |
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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 |
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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 | 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
| 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 | |
E.8.9.1 | In the Member State concerned days | 25 |