Prophylaxis of Influenza
Conditions
Interventions
Trade Name: Enzira
Product Name: Enzira vaccine
Product Code: Influenza Vaccine CSL Limited
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: A/ Solomon islands/3/2006 (H1N1)-like vir
A/Wisconsin/67/2005 (H3N2)-like virus
B/Malaysia/2506/2004-like virus
Other descriptive name: influenza haemagglutinin antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 45-
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. Be able to provide a sample of up to 20 mL of venous blood on 2 separate occasions without undue distress/discomfort; 4. Negative pregnancy test at enrolment before receiving Study Vaccine (female participants of child-bearing potential ONLY). Those at risks of pregnancy during the study period must, in the opinion of the Investigator, 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 eggs, chicken protein, neomycin, polymyxin, or any components of the vaccine; 2. Vaccination against influenza within the previous 6 months 3. Clinical signs of active infection and/or an oral temperature of = 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: = 15 mg/day of oral prednisolone or equivalent daily; - sporadic corticosteroids: = 40 mg/day of oral prednisolone or equivalent for two or more short courses of > 3 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 (i.e. a new chemical or biological entity not registered for clinical use) within 90 days prior to receiving the study vaccine or plans to enter a 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 Guillain-Barre syndrome; 10. Active neurological disease; 11. Current treatment with warfarin or other anticoagulant; 12. Physical/Medical history that the investigator feels may adversely 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 the participant from giving proper informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunogenicity of Enzira vaccine in healthy adults aged = 18 to < 60 years of age and in healthy older adults aged = 60 years of age according to the criteria of the CPMP/BWP/214/96 Note for guidance on harmonisation of requirements for Influenza vaccines.;Primary end point(s): To meet at least one of the three immunogenicity criteria, applicable for each strain, as defined in the CPMP/BWP/214/96 Note for guidance on harmonisation of requirements for Influenza vaccine.;Secondary Objective: To evaluate the safety of Enzira vaccine in healthy adults aged = 18 to < 60 years of age and in healthy older adults aged = 60 years of age through: - the assessment of the frequency of solicited local reactions and general symptoms for three days following vaccination. - the assessment of unsolicited adverse events of more than 2 days duration. | — |
Countries
United Kingdom
Outcome results
None listed