The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older
Completed · Phase 3
Conditions studied: Influenza, Human
In brief
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 older (approximately equally split between two age groups: 50-64 years; 65 years and older), who are healthy or have stable comorbidities that increase their risk of complications from influenza infection. Three lots of aQIVc will be evaluated for consistency and pooled for the comparison with the 2 control vaccines. Subjects will be randomly assigned to receive 1 of 3 lots of aQIVc, QIVr, or aQIV in a 1:1:1:2:2 ratio (for a 3:2:2 ratio for aQIVc, QIVr, and aQIV). The study will have a treatment period (Day 1 to Day 29) and a follow-up period (Day 30 up to Day 181); a subset of 770 subjects will be followed up up to Day 365.
Key facts
- Study ID
- NCT06015282
- Run by
- Seqirus
- People needed
- 7741
- Starts
- 2023-11-03
- Expected to finish
- 2025-01-30
- Last updated by the study team
- 2025-04-27
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
- Marvel Clinical Research — Huntington Beach, California, United States
- Paradigm Clinical Research Center, LLC — Redding, California, United States
- Clinical Research Consulting, Inc. — Milford, Connecticut, United States
- Chase Medical Research, LLC — Waterbury, Connecticut, United States
- Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
- USA and International Research Inc. — Doral, Florida, United States
- Velocity Clinical Research, New Smyrna Beach — Edgewater, Florida, United States
- Health Awareness, Inc. — Jupiter, Florida, United States
- ARS - Lake Oconee — Largo, Florida, United States
- Global Health Research Center — Miami Lakes, Florida, United States
- Precision Clinical Research — Sunrise, Florida, United States
- Global Health Research center — Tampa, Florida, United States
- Velocity Clinical Research- Boise — Meridian, Idaho, United States
- Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research — Chicago, Illinois, United States
- Great Lakes Clinical Trials, LLC. Ravenswood dba Flourish Research — Gurnee, Illinois, United States
- Velocity Clinical Research Valparaoso — Valparaiso, Indiana, United States
- Velocity Clinical Research, Sioux City — Sioux City, Iowa, United States
- Velocity Clinical Research, Baton Rough — Baton Rouge, Louisiana, United States
- Benchmark Research — Metairie, Louisiana, United States
- IMA Evaluations LLC — Monroe, Louisiana, United States
- Centennial Medical Group, PC — Columbia, Maryland, United States
- Velocity Clinical Research Rockville — Rockville, Maryland, United States
- Velocity Clinical Research Gulfport — Gulfport, Mississippi, United States
- Alliance for Multispecialty Research (AMR) Phoenix — Tempe, Arizona, United States
Full record on ClinicalTrials.gov
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