The Celljuvant study, A phase 3 Immunogenicity and Safety Study of aQIVc HD Vaccine in Adults aged 50 years and older.
- Conditions
- Healthy individuals or individuals with stable comorbidities which increase their risk ofcomplications from influenza infection.MedDRA version: 20.0Level: PTClassification code: 10022000Term: Influenza Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2023-503763-42-00
- Lead Sponsor
- Seqirus UK Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6300
Individuals, aged 50 years and older, who are healthy or have stable comorbidities that increase their risk of complications from influenza infection, Individuals who can comply with all study procedures
Progressive, unstable, or uncontrolled clinical conditions, Known hypersensitivity or allergy to any study vaccine component, Known history of Guillain-Barré syndrome or other demyelinating disease, Condition representing a contraindication to vaccination or blood draw, Abnormal function of immune system due to know disorder or medication, Influenza vaccination within 180 days prior to informed consent or plan to receive influenza vaccine within 9 months from study vaccination (all subjects) or within 12 months (subjects in the long-term subset for immunogenicity)..
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