E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059429 |
E.1.2 | Term | Influenza immunisation |
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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 evaluate the immunogenicity of the 2010/2011 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 2010/2011 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. Participants capable of understanding the purposes and risks of the study and are able to provide written informed consent. 3. Willing and able to adhere to all protocol requirements 4. Assessed as being able to provide a sample of approximately 17 mL of venous blood on two separate occasions without undue distress / discomfort. 5. 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. Accepted contraceptive precautions include: oral contraception, intrauterine contraceptive device or equivalent hormonal contraception (e.g., progestogen-only implant, vaginal contraceptive ring, transdermal hormonal patch or injectable contraceptives), abstinence, partner vasectomy, acceptable barrier methods used routinely in conjunction with spermicide (either by participant or participant's partner). Females of child-bearing potential must return a negative urine pregnancy test result at Visit 1, prior to vaccination with the 2010/2011 formulation of Enzira® vaccine.
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E.4 | Principal exclusion criteria |
1. Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Enzira® vaccine. 2. Clinical signs of an active infection and/or an elevated oral temperature (38.0°C or higher) at study entry. 3. A clinically significant medical or psychiatric condition, such as: • For acute conditions (active or recent); the condition required hospitalisation within the last month; or • For chronic conditions: the Investigator feels that the chronic condition is unstable, such as illness exacerbations within the previous month: i. requiring hospitalisation; ii. with significant organ function deterioration; iii. with major changes to treatment dosages; iv. requiring major new treatments; or • The Investigator feels the participant has a clinical condition that may be adversely affected through study participation. 4. A confirmed or suspected immunosuppressive condition (congenital or acquired; including cancer and human immunodeficiency virus infection). 5. History of seizures, with the exception of a past history of a single seizure event at any age that occurred more than 2 years previously. 6. History of Guillain-Barré Syndrome. 7. Vaccination with a seasonal influenza virus vaccine or with an experimental influenza virus vaccine (e.g. a candidate pandemic influenza virus vaccine or a novel influenza virus vaccine) in the 6 months preceding administration of the Enzira® vaccine. This includes vaccination with the 2009 H1N1 pandemic influenza vaccine in the 6 months preceding administration of the Enzira® vaccine. 8. Currently receiving treatment with radiotherapy or cytotoxic drugs, or has received such treatment within the 6 months preceding administration of the Enzira® vaccine. 9. Currently receiving systemic glucocorticoid therapy (excluding topical, inhaled or intra-articular preparations) or has received such therapy within the 3 months preceding administration of the Enzira® vaccine: • 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 2 or more short courses of > 3 days in the 3 months preceding vaccination; 10. Currently receiving immunoglobulins and/or any blood products or has received such treatment within the 3 months preceding the administration of the Enzira® vaccine. 11. Currently participating in another investigational study or recent study participation ending 3 months preceding administration of the Enzira® vaccine. 12. Currently receiving treatment with warfarin or other anticoagulants. 13. Evidence or history of substance or alcohol abuse within the 12 months before administration of the Enzira® vaccine. 14. Females of child bearing potential, who were planning to become pregnant or planning to discontinue contraceptive precautions during the study period. 15. Females who are pregnant or lactating. 16. Any issues that, in the opinion of the Investigator, would render the subject unsuitable for study participation.
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E.5 End points |
E.5.1 | Primary end point(s) |
For the Adult Cohort, the CPMP Criteria are as follows: - The proportion of participants achieving seroconversion or significant increase* in antibody titre should be > 40% of the evaluable population. - The geometric mean fold increase (GMFI)* * should be > 2.5. - The proportion of participants achieving a haemagglutination inhibition (HI) titre ≥ 40 or single radial haemolysis (SRH) area ≥ 25 mm2 should be > 70% of the evaluable population.
For the Older Adult Cohort, the CPMP Criteria are as follows: - The proportion of participants achieving seroconversion or significant increase* in antibody titre should be > 30% of the evaluable population. - The GMFI** should be > 2.0. - The proportion of participants achieving a HI titre ≥ 40 or SRH area ≥ 25 mm2 should be > 60% of the evaluable population.
*For HI, seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10. For SRH, seroconversion is defined as achieving a post-vaccination area of ≥ 25 mm2 for those participants with a pre-vaccination SRH area of 4 mm2; significant increase is defined as a 50% or greater increase in SRH area for those participants with a pre-vaccination SRH urea > 4 mm2. ** GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.
For each age cohort, at least one of the three endpoints listed above should be met, for each strain included in the 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 | 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 | 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.8.3 |
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.8.5 | 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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 25 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |