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 range50 Years – 70 Years
SexALL
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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.
✓. 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.
✕
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
. 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.