Prophylaxis of influenza MedDRA version: 12.1 Level: LLT Classification code 10059429 Term: Influenza immunisation
Conditions
Interventions
Trade Name: Enzira® suspension for injection, in pre-filled syringe.
Influenza vaccine (Split Virion, inactivated) Ph Eur.
Product Name: 2010/2011 Formulation of Enzira® Vaccine (Inactivated Influenz
Sponsors
CSL Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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). ;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 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. | — |
Countries
United Kingdom
Outcome results
None listed