Influenza, human
Conditions
Interventions
Trade Name: Enzira® vaccine
Product Name: Trivalent Influenza Vaccine
Product Code: Influenza Vaccine CSL Limited
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: California/7/2009 (
Sponsors
bioCSL Pty Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Males or females aged between 18 and 60 years at the time of vaccination. * 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. 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 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine. * Clinical signs of an active infection. * A clinically significant medical condition. * Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry. * Females who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunogenicity of the study vaccine in healthy adults aged 18 to 60 years according to the criteria outlined in the CPMP Note for Guidance on Harmonisation of Requirements for Influenza Vaccines (CPMP/BWP/214/96). ;Secondary Objective: To evaluate the safety of the study vaccine in adults aged 18 to 60 years. ;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 |
|---|---|
| Secondary end point(s): Frequency of any solicited adverse events (AEs) Frequency of any unsolicited AEs ;Timepoint(s) of evaluation of this end point: Solicited - During the 4 days after vaccination (Day 0 plus 3 days) Unsolicited - After vaccination until the end of the study; approximately 21 days. | — |
Countries
United Kingdom
Contacts
Public ContactCSL Clinical Trials
bioCSL Pty Ltd
Outcome results
None listed