Prophylaxis of influenza MedDRA version: 9.1 Level: LLT Classification code 10022000 Term: 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/Brisbane/59/2007 (H1N1)-like virus, A/Brisbane/
Sponsors
CSL Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females aged = 18 years at the time of providing informed consent. 2. Participants are 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. Able to provide a sample of up to 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 are determined as: oral contraception, intrauterine contraceptive device or equivalent hormonal contraception (e.g. progestogen-only implant, vaginal contraceptive ring, cutaneous hormonal patch or injectable contraceptives), abstinence, partner vasectomy, condoms used in conjunction with spermicide. Females of child bearing potential must return a negative urine pregnancy test result at enrolment, prior to vaccination with 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) at study entry. 3. A clinically significant medical or psychiatric condition, as follows: • 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 occured 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 study entry. 8. Currently receiving treatment with radiotherapy or cytotoxic drugs, or have received such treatment within the 6 months preceding administration of the Enzira® vaccine. 9. Currently receiving systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry: • 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 have 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 study entry. 14. Females of child bearing potential who are 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 2009/2010 formulation of the Enzira® vaccine in healthy ‘Adults’ (aged = 18 to < 60 years) and in healthy ‘Older Adults’ (aged = 60 years) according to the criteria outlined in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines.;Secondary Objective: To evaluate the safety of the 2009/2010 formulation of Enzira® vaccine in healthy ‘Adults’ (aged = 18 to < 60 years) and in healthy ‘Older Adults’ (aged = 60 years).;Primary end point(s): Immunogenicity of Enzira® vaccine will be assessed in the two groups of healthy volunteers (‘Adults’ and ‘Older Adults’) according to the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. Enzira® vaccine will be considered immunogenic for a given strain if at least one of the three immunogenicity criteria is met. | — |
Countries
United Kingdom
Outcome results
None listed