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Cancer Vaccine

aQIVc Vaccine for Flu in Adults 50+

Phase 3
Waitlist Available
Research Sponsored by Seqirus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 365
Awards & highlights

Study Summary

This trial will study the safety & effectiveness of 3 flu vaccines in 7700 adults age 50+ with or without health conditions.

Who is the study for?
This trial is for adults aged 50 and older who are either healthy or have stable health issues that could make flu complications worse. They must be able to follow the study's procedures but can't join if they have immune problems, recent flu shots, Guillain-Barré syndrome, allergies to vaccine ingredients, or serious unstable conditions.Check my eligibility
What is being tested?
The study tests three batches of a new flu vaccine called aQIVc against two existing vaccines (QIV1 and QIV2). Participants will be randomly assigned in specific ratios to receive one of these vaccines. The main goal is to compare how well each vaccine works and their safety over different periods up to one year.See study design
What are the potential side effects?
Common side effects from flu vaccines include pain at the injection site, fatigue, headache, muscle pain, feverish feelings. Rarely there might be allergic reactions. Since this involves an investigational vaccine as well as licensed ones, unexpected side effects may also occur.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immunogenicity Endpoint: Humoral immune responses of 3 lots of aQIVc compared in pairs in terms of Day 29 GMT ratio between each pair among the 3 lots, from antibody titers measured via HI assay.
Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 and QIV2 vaccines in terms of Day 1 to Day 29 SCR and SCR difference, from antibody titers measured via HI assay.
Secondary outcome measures
Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 and QIV2 vaccines in terms of Day 29 GMT and GMT ratio of antibodies measured via HI assay.
Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 vaccine in terms of Day 29 SCR and SCR difference, GMT and GMT ratio of antibodies measured via HI assay in subjects 65 years and older.
Immunogenicity Endpoints: For aQIVc and QIV1 vaccines, Day 29 GMT, Day 1 to Day 29 GMFI, Percentage of subjects with HI titer ≥1:40 at Day 29, Day 1 to Day 29 SCR, SCR differences, and GMT ratio of antibodies measured via HI assay.
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Investigational aQIVc groupExperimental Treatment1 Intervention
Group II: licensed QIV1 groupActive Control1 Intervention
Group III: licensed QIV2 groupActive Control1 Intervention

Find a Location

Who is running the clinical trial?

SeqirusLead Sponsor
59 Previous Clinical Trials
1,073,329 Total Patients Enrolled
Clinical Program DirectorStudy DirectorSeqirus
13 Previous Clinical Trials
68,385 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How secure are the outcomes of those receiving investigational aQIVc treatments?

"After careful review, the safety of aQIVc was rated 3 on our scale due to prior clinical evidence confirming its efficacy and multiple studies that back up its safety."

Answered by AI

Are there still opportunities to enroll in the study?

"According to the records available on clinicaltrials.gov, this research investigation is currently seeking patients. The initial posting was made on November 3rd 2023 and pertinent updates were recently applied on November 7th of the same year."

Answered by AI

How many locations are conducting this investigation in the urban area?

"Patients can enroll at 49 different clinic locations across Europe, such as emovis GmbH in Dresden, Klinische Forschung Dresden GmbH in Essen, and Studienzentrum Bocholderstrasse in Hamburg."

Answered by AI

How many subjects are taking part in the current research?

"Seqirus is looking to enrol 7,700 suitable participants for their clinical trial across two locations: emovis GmbH in Dresden, Alberta and Klinische Forschung Dresden GmbH in Essen, Ontario."

Answered by AI

Who else is applying?

What site did they apply to?
Alliance for Multispecialty Research (AMR) Phoenix
Velocity Clinical Research
Alliance for Multispecialty Research LLC, Las Vegas
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I'm interested in being part of medical advances.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older
2023. "The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06015282.
All > Paid Studies Las Vegas > Knoxville
~5161 spots leftby Apr 2025
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