A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine containing the 2013/2014 Formulation of Enzira® vaccine in Healthy Volunteers

Conditions: Influenza, human
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2013-001420-19-GB

Lead Sponsor: bioCSL Pty Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

* 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the immunogenicity of the study vaccine in healthy adults aged 18 to 60 years<br>according to the criteria outlined in the CPMP Note for Guidance on Harmonisation of<br>Requirements for Influenza Vaccines (CPMP/BWP/214/96).<br><br>;Secondary Objective: To evaluate the safety of the study vaccine in adults aged 18 to 60 years.<br><br>;Primary end point(s): The percentage of evaluable participants achieving seroconversion or significant increase in antibody titre.<br><br>The geometric mean fold increase (GMFI) in antibody titre after vaccination.<br><br>The percentage of evaluable participants achieving a HI titre = 40 or single radial haemolysis (SRH) area = 25 mm2.<br>;Timepoint(s) of evaluation of this end point: Approximately 21 days after vaccination<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Frequency of any solicited adverse events (AEs)<br><br><br>Frequency of any unsolicited AEs<br>;Timepoint(s) of evaluation of this end point: Solicited - During the 4 days after vaccination (Day 0 plus 3 days)<br><br>Unsolicited - After vaccination until the end of the study; approximately 21 days.<br>