Status:
COMPLETED
The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older
Lead Sponsor:
Seqirus
Conditions:
Influenza, Human
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
This is a Phase 3, randomized, parallel-group, comparator-controlled, observer-blind, multicenter study of immunogenicity and safety in approximately 7700 male and female adults aged 50 years and olde...
Eligibility Criteria
Inclusion
- Main
- 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
- Main
Exclusion
- 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 known disorder or medication.
- Influenza vaccination within 180 days prior to informed consent.
Key Trial Info
Start Date :
November 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2025
Estimated Enrollment :
7741 Patients enrolled
Trial Details
Trial ID
NCT06015282
Start Date
November 3 2023
End Date
January 30 2025
Last Update
April 27 2025
Active Locations (96)
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1
Alliance for Multispecialty Research (AMR) Phoenix
Tempe, Arizona, United States, 85281
2
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205
3
Marvel Clinical Research
Huntington Beach, California, United States, 92647
4
Paradigm Clinical Research Center, LLC
Redding, California, United States, 96001