E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
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 the 2012/2013 formulation of the Enzira® vaccine in ‘Adults’ (aged 18 to 59 years) and in ‘Older Adults’ (aged 60 years or older) according to the criteria outlined in the CPMP Criteria.
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of the 2012/2013 formulation of the Enzira® vaccine in ‘Adults’ (aged 18 to 59 years) and in ‘Older Adults’ (aged 60 years or older).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Males or females aged 18 years or older at the time of vaccination.
2. Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine."
3. willing and able to adhere to protocol requirements
4. participants must be capable of understanding the purpose and risks of the study and able to provide written informed consent
5. able to provide sample of approximately 10 mL venous blood on 2 occasions without undue stress |
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E.4 | Principal exclusion criteria |
1. Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the Enzira vaccine.
2. Clinical signs of an active infection and/or elevated oral temperature at study entry.
3. A clinically significant medical or psychiatric condition.
4. Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
5. Females who are pregnant or lactating or planning to become pregnant during the study period.
6. Confirmed or suspected immunosuppressive condition
7. History of seizures
8. History of Guillain-Barre syndrome
9. Currently receiving treatment with warfarin or other anticoagulants
10. Currently receiving treatment with systemic glucocorticoid therapy or within 3 months preceding Enzira vaccine administration
11. Currently receiving treatment with radiotherapy or cytotoxic drugs or within 6 months or administration of Enzira vaccine
12. Currently receiving immunoglobulins and/or blood products or within 3 months of study entry
13. Currently participating in another investigational study or ended such participation within 1 month of administration of Enzira vaccine |
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E.5 End points |
E.5.1 | Primary end point(s) |
The percentage of evaluable participants achieving seroconversion or significant increase in antibody titre.
The geometric mean fold increase (GMFI) in antibody titre after vaccination.
The percentage of evaluable participants achieving a HI titre ≥ 40 or single radial haemolysis (SRH) area ≥ 25 mm2.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Approximately 21 days after vaccination
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E.5.2 | Secondary end point(s) |
Frequency and intensity of any solicited adverse events (AEs)
Frequency of any unsolicited AEs
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During the 4 days after vaccination (Day 0 plus 3 days) for solicited adverse events(AEs).
After vaccination until the end of the study; approximately 21 days for any unsolicited adverse events(AEs).
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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 | Yes |
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 | 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) | 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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | No |
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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Exit (last) visit for the last participant |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |