Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine (NCT04961541) | Clinical Trial Compass
CompletedPhase 1/2
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
Australia637 participantsStarted 2021-09-08
Plain-language summary
This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent HA nanoparticle influenza and SARS-CoV-2 rS nanoparticle combination vaccine with Matrix-M1 adjuvant; this combination is referred to as ICC vaccine.
Who can participate
Age range
50 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy, medically stable adult males or females ≥ 50 to ≤ 70 years of age at screening.
. Willing and able to give informed consent prior to study enrollment.
. Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
. Participants must have been baseline seropositive to SARS-CoV-2 defined as either:
. Women of childbearing potential (defined as any female participant who is NOT surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was testing a combination influenza and COVID-19 vaccine — since it's already completed, has the safety data been published, and what did it show about the types of side effects people reported?
2Since this was a Phase 1/Phase 2 trial, what does that mean for how much we know about whether this combination vaccine is actually effective, versus just whether it appeared safe enough to continue studying?
3The trial specifically tracked serious adverse events and something called PIMMCs — can you explain what those are and whether any were reported at a concerning rate in this study?
4Is a combined influenza and COVID-19 vaccine like the one studied here available or approaching availability now, and would it be something worth considering for my situation compared to getting the two separate shots?
5Are there follow-on or later-phase trials building on this one that might be enrolling, or would you recommend sticking with currently approved individual vaccines while that research continues?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Solicited Local and Systemic Adverse Events (AE's)
Timeframe: Day 0 to Day 63
2
Number of Participants Reporting All AE's
Timeframe: Day 0 to Day 70
3
Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs
. Condoms (male or female) with spermicide (if acceptable in-country)
. Diaphragm with spermicide
. Cervical cap with spermicide
Exclusion criteria
. Any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care.
. Participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection.
. Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection.
. History of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product.
. Any history of anaphylaxis to any prior vaccine.
. History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine.
. Receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. Note: Routine vaccinations will not be allowed until after study Day 70.
. Any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination.