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: - the assessment of the frequency of solicited local reactions and general symptoms for three days following vaccination. - the assessment of unsolicited adverse events 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 2 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 risks 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 ≥ 38 °C 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-Barre 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 vaccine. |
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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 | 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 | 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 | 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) | 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 | Yes |
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.8.5.1 | Number of sites anticipated in the EEA | 1 |
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
| |
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 |