Influenza, human
Conditions
Interventions
Trade Name: Enzira suspension for injection, in pre-filled syringe. Influenza vaccine (split virion, inactivated)
Product Name: 2012/2013 Formulation of Enzira Vaccine (Inactivated Influenza Vaccine C
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. 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 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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). ;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. ;Timepoint(s) of evaluation of this end point: Approximately 21 days after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). ;Secondary end point(s): Frequency and intensity of any solicited adverse events (AEs) Frequency of any unsolicited AEs | — |
Countries
United Kingdom
Contacts
Public ContactGlobal Clinical Program Director
CSL Behring GmbH
Outcome results
None listed