Prophylaxis of influenza
Conditions
Interventions
Trade Name: Enzira
Product Name: Enzira
Product Code: Influenza Vaccine CSL Limited
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: A/New Caledonia/20/99(H1N1)-like virus, A/Wiscons
Sponsors
CSL Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. healthy adults aged >= 65 years at the time of informed consent 2. provides written informed consent and adherence to all protocol requirements 3. is in good health, as determined by medical history and physical examination where indicated 4. is able to understand and comply with planned study procedures 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. Hypersensitivity to eggs, chicken protein, neomycin, polymyxin, gentamicin sulphate, formaldehyde, sodium deoxycholate, thiomersal or any components of the Study Vaccines; 2. Interpandemic vaccination against influenza or laboratory culture confirmed Influenza in 2006; 3. Vaccination with an experimental influenza vaccine (eg. a candidate pandemic influenza vaccine or a novel influenza vaccine) in 2006; 4. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality; 5. Known history of Guillain-Barré Syndrome; 6. Clinical signs of active infection and/or an oral temperature of >= 38°C (100.4°F). Study entry may be deferred for such individuals, at the discretion of the Principal Investigator (PI); 7. Active neurological disease; 8. Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder; 9. Current treatment with warfarin or other anticoagulant; 10. Current (or within the 90 days prior to receiving the Study Vaccines) immunosuppressive or immunomodulative therapy, including systemic corticosteroids, as follows: · Chronic or long term corticosteroids: >15mg/day of oral prednisolone or equivalent daily; · Sporadic corticosteroids: >40mg/day of oral prednisolone or equivalent for more than two courses of >14 days in the three months preceding vaccination; · Administration of immunogobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine or during the study Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccines or throughout the Study is acceptable. 11. Participation in a clinical trial where the participant received an investigational product or use of an investigational compound (i.e. a new chemical or biological entity not registered for clinical use) within 30 days prior to receiving the Study Vaccines or plans to enter a clinical trial during the study period; 12. Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccines; 13. Current treatment, or treatment with cytotoxic drugs or radiotherapy at any time during the six months prior to administration of the Study Vaccines; 14. Major congenital defects or serious chronic illness; 15. Evidence, or history (within the previous 12 months) of drug or alcohol abuse; 16. Unwillingness or inability to comply with the study Protocol; 17. History of psychiatric disorders, which, in the opinion of the Principal Investigator (PI), would prevent participants from giving proper informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that vaccination with Enzira (2006/2007) produces an immune response sufficient to meet the Committee for Proprietary Medicinal Products (CPMP) criteria for Older Adults of >30% seroconversion and >60% seroprotection;Secondary Objective: 1. To demonstrate that Enzira (2006/2007) is no more reactogenic than GlaxoSmithKline Influenza Vaccine (Fluarix or Influsplit) (2006/2007) in Healthy Older Adults aged >=65 years 2. To demonstrate that vaccination with Enzira (2006/2007) produces an immune response in Healthy Older Adults aged >= 65 years sufficient to meet the criteria of the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines in Older Adults ;Primary end point(s): Co-primary immunogenicity endpoints of seroprotection rate and seroconversion rate will be assessed. Seroprotection is defined as a minimum post vaccination haemagglutination inhibition (HI) titre of 1:40. Seroconversion is defined as an increase in Hi antibody titre of at least 4-fold, with a minimum post vaccination HI titre of 1:40 | — |
Countries
United Kingdom
Outcome results
None listed