This is a study to assess the safety and immune (antibody) response of a CSL inactivated influenza virus vaccine in a healthy paediatric, adult and senior adult populations.
- Conditions
- Influenza, humanTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-000177-12-Outside-EU/EEA
- Lead Sponsor
- CSL Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active
- Sex
- All
- Target Recruitment
- 720
Healthy subjects aged =>3 years to =< 80 years. Be able to provide a pre and post vaccination sample of up to 3 mL of venous blood. Females of reproductive age who are not pregnant must agree to use contraception.
Are the trial subjects under 18? yes
Number of subjects for this age range: 270
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
Hypersensitivity to eggs, chicken protein, neomycin, polymyxin or any components of the vaccine. Influenza vaccination in the previous 6 months. Clinical signs of active infection and/or an axillary temperature of =>37.1°C at study entry. Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving Study Vaccine.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method