EUCTR2015-000177-12-Outside-EU/EEAActive, not recruitingNot Applicable
An Observer-Blind, Randomized, Comparator-Controlled, Single-Centre Study to Evaluate the Tolerability, Safety, and Immunogenicity of Inactivated Influenza Vaccine, CSL Limited in a Healthy Pediatrics and Adult Population (aged =>3 years to =< 80 years)
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- CSL Limited
- Enrollment
- 720
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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