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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
Must not have
Known or suspected congenital or acquired immunodeficiency or receipt of specific immunosuppressive therapies
Moderate or severe acute illness/infection or febrile illness on the day of study intervention administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 182 through 12 months following the last study vaccination
Summary
"This trial aims to test the safety and effectiveness of a new combination vaccine for influenza and COVID-19 in adults aged 50 years and older in the United States. The study will involve around 980
Who is the study for?
This trial is for adults aged 50 or older in the U.S. who can get shots in both arms, have completed their initial COVID-19 vaccine series plus a booster, and are either not able to have children or agree to use contraception. They should be healthy or with stable pre-existing conditions.
What is being tested?
The study tests a combination vaccine of recombinant influenza (RIV) and different levels of adjuvanted recombinant COVID-19 (rC19) vaccines against RIV alone, rC19 alone, and placebo. Participants will receive two injections on Day 1 and follow-ups over approximately one year.
What are the potential side effects?
Potential side effects may include typical reactions at the injection site like pain or swelling, flu-like symptoms such as fever or fatigue, allergic reactions, and possibly others that are currently unknown.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
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I can receive injections in both of my shoulders.
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I have completed the initial COVID-19 vaccination series and received at least one booster shot.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a weak immune system due to a condition or treatment.
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I do not have a fever or severe illness right now.
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I or my family have a history of Guillain-Barré syndrome or heart-related issues.
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I do not have conditions like low platelet count or bleeding disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day 182 through 12 months following the last study vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 182 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 Day 30/Day 01 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: RIV + 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: RIV + rC19 (dose 3) (in right or left deltoid) and placeboExperimental Treatment2 Interventions
two IM injections on D01
Group III: Group 5: RIV + rC19 (dose 2) (in right or left deltoid) and placeboExperimental Treatment2 Interventions
two IM injections on D01
Group IV: Group 4: RIV + 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: RIV (in right or left deltoid) and rC19 (dose 1) (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: RIV (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