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Cancer Vaccine
Combination Vaccine for COVID-19 and Flu
Phase 1 & 2
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Aged 50 years or older on the day of inclusion
* Participant must be able to receive an injection in the deltoid muscle of both arms.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from d182 through 12 months following the last study vaccination
Summary
"This trial aims to test a new vaccine that combines a high-dose flu vaccine with a COVID-19 vaccine in adults aged 50 and older in the US. The study will involve around 980
Who is the study for?
Adults aged 50 and older who have completed their primary COVID-19 vaccination series plus a booster can join this trial. They must be healthy or have stable pre-existing conditions, able to get shots in both arms, attend all visits, and follow study procedures. Women must not be able to bear children or agree to use contraception.
What is being tested?
The trial is testing the safety and immune response of a high-dose flu shot combined with different levels of a new COVID-19 vaccine compared to each vaccine alone or with placebo. Participants will receive two injections at the start and will be monitored for about one year.
What are the potential side effects?
Potential side effects may include typical reactions at the injection site like pain, redness, swelling, as well as general symptoms such as fever, fatigue, headache which are common after vaccinations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
Select...
I can receive injections in both of my shoulders.
Select...
I am a woman able to have children and have a negative pregnancy test.
Select...
I am fully vaccinated and boosted against COVID-19.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from d182 through 12 months following the last study vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from d182 through 12 months following the last study vaccination
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
GM of SARS-CoV-2 neutralizing titers in all participants
GMR of SARS-CoV-2 neutralizing titers ratio D30/D01 in all participants
Geometric mean (GM) of HAI titers in all participants
+11 moreSecondary study objectives
Percentage of participants with HAI titer ≥ 10 (1/dil) in all participants
Percentage of participants with HAI titer ≥ 40 (1/dil) in all participants
Percentage of participants with seroconversion in all participants
+1 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: Group 7: IIV-HD + rC19 (dose 4) (in right or left deltoid) and placebo (in opposite deltoid)Experimental Treatment2 Interventions
two IM injections on D01
Group II: Group 6: IIV-HD + rC19 (dose 3) (in right or left deltoid) and placebo (in opposite deltoid)Experimental Treatment2 Interventions
two IM injections on D01
Group III: Group 5: IIV-HD + rC19 (dose 2) (in right or left deltoid) and placebo (in opposite deltoid)Experimental Treatment2 Interventions
two IM injections on D01
Group IV: Group 4: IIV-HD + rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid)Experimental Treatment2 Interventions
two IM injections on D01
Group V: Group 3: IIV-HD (in right or left deltoid) and rC19 (dose1) (in opposite deltoid)Experimental Treatment2 Interventions
two IM injections on D01
Group VI: Group 2: rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid)Experimental Treatment2 Interventions
two IM injections on D01
Group VII: Group 1: IIV-HD (in right or left deltoid) and placebo (in opposite deltoid)Experimental Treatment2 Interventions
two IM injections on D01
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
SanofiLead Sponsor
2,216 Previous Clinical Trials
4,046,652 Total Patients Enrolled