prophylaxis of influenza
Conditions
Sponsors
CSL Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Healthy males or females, aged > 18 years at the time of providing informed consent 2.Provision of written informed consent to participate in the study and willingness to adhere to all protocol requirements 3.Ability to provide a sample of up to 20 mL of venous blood without undue distress/discomfort on two occasions 4.Negative pregnancy test at enrolment before receiving Study Vaccine (Female participants of childbearing potential ONLY). Those at risk of pregnancy during the study period must, in the opinion of the Investigator/delegate, be taking/using adequate methods of contraception Adequate methods are defined as: ·Oral contraception ·Intrauterine contraceptive device ·Depot contraceptive (implants/injectables) ·Abstinence ·Partner Vasectomy ·Condoms with spermicide 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 the active substances, to any of the excipients or to residues of the production process in either Study Vaccine (eggs, egg protein, chicken protein, neomycin, polymyxin, formaldehyde, diethylether or polysorbate 80) 2.Vaccination against influenza within the previous 6 months 3.Clinical signs of active infection and/or an oral temperature of ³ 38°C at study entry. Study entry may be deferred for such individuals, at the discretion of the PI/delegate. 4.Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder 5.Current (or within the 90 days prior to receiving the Study Vaccine) 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;Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable. 6.Participation in a clinical trial or use of an investigational compound (ie a new chemical or biological entity not registered for clinical use) within 90 days prior to receiving the Study Vaccine or plans to enter another study during the study period 7.Vaccination with any registered vaccine within 30 days prior to receiving the Study Vaccine 8.Current treatment, or treatment with cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine 9.Known history of Guillan-Barré Syndrome 10.Active neurological disease 11.Current treatment with warfarin or other anticoagulant 12.Physical/Medical history that the Investigator feels may affect the participant or study results 13.Evidence, or history (within the previous 12 months) of drug or alcohol abuse 14.Unwillingness or inability to comply with the study protocol 15.History of psychiatric disorders, which, in the opinion of the Principal Investigator, would prevent participants from giving proper informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the immune response following vaccination with Enzira 2005/2006 in Healthy ‘Adults’ aged > 18 to 60 years meets the criteria of the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines.;Primary end point(s): Immune response following administration of Enzira 2005/2006 using the three age-specific CPMP criteria; Secondary Objective: 1. To demonstrate that vaccination with Enzira 2005/2006 elicits a non-inferior immune response compared to vaccination with Mutagrip 2005/2006 in Healthy ‘Adults’ aged > 18 to 60 years according to the criteria of the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. 2. To demonstrate that Enzira 2005/2006 is no more reactogenic, in Healthy ‘Adults’ aged > 18 to 60 years than Mutagrip 2005/2006 according to the criteria of the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. | — |
Countries
United Kingdom
Outcome results
None listed