Influenza, human
Conditions
Interventions
Trade Name: Enzira® vaccine
Product Name: Enzira® vaccine
Product Code: Influenza Vaccine CSL Limited
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: California/7/2009 (H1N1) pdm09
Sponsors
bioCSL Pty Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Males or females aged 18 years or older 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
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 2013/2014 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 2013/2014 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 |
|---|---|
| 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