The Celljuvant Study: a Phase 3 Immunogenicity and Safety Study of AQIVc Vaccine in Adults Aged 50 Years and Older

Seqirus

Status and phase: Active, not recruiting; Phase 3

Conditions: Influenza, Human

Treatments: Biological: licensed QIV2; Biological: Investigational aQIVc; Biological: licensed QIV1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06015282

V201_03

Details and patient eligibility

About

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, QIV1, or QIV2 in a 1:1:1:2:2 ratio (for a 3:2:2 ratio for aQIVc, QIV1, and QIV2).

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.

Enrollment: 7,741 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• 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 Criteria:

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7,741 participants in 3 patient groups

Investigational aQIVc group

Experimental group

Treatment:

Biological: Investigational aQIVc

licensed QIV1 group

Active Comparator group

Treatment:

Biological: licensed QIV1

licensed QIV2 group

Active Comparator group

Treatment:

Biological: licensed QIV2