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Cancer Vaccine
mRNA Vaccine for Flu
La Mesa, CA
Phase 1 & 2
Waitlist Available
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 years or older on the day of inclusion
A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before the first dose of study intervention
Must not have
Moderate or severe acute illness/infection or febrile illness on the day of study intervention
Previous history of myocarditis, pericarditis, and/or myopericarditis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study, approximately 13 months
Summary
This trial will test a new pandemic flu vaccine on 276 healthy adults at different dose levels to see which one works best compared to a placebo. Each participant will be in the study for about 13
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Who is the study for?
This clinical trial is open to healthy adults aged 18 and older who are interested in testing a new pandemic flu H5 mRNA vaccine. The study aims to find the right dose for further research. Participants will be involved for about 13 months.Check my eligibility
What is being tested?
The trial is testing three different doses of a new pandemic flu H5 mRNA vaccine against a placebo, which has no active ingredients. It's designed to see how safe the vaccine is and how well it triggers an immune response.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with vaccines such as soreness at injection site, fever, fatigue, headache, muscle pain, chills or joint pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am a woman who can have children and have tested negative for pregnancy recently.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a severe illness or fever today.
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I have had myocarditis, pericarditis, or myopericarditis in the past.
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My heart test shows signs of inflammation or other serious issues.
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I haven't had COVID-19 or symptoms in the last 10 days.
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I have a history of neurological conditions like GBS or encephalitis.
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I have a low platelet count that prevents me from getting shots in my muscles.
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I have not received any blood products or immune globulins in the last 3 months.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the study, approximately 13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, approximately 13 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Presence of adverse events of special interest (AESIs) throughout the study
Presence of immediate adverse events (AEs) within 30 minutes after each/any injection
Presence of medically attended adverse events (MAAEs) through 180 days after the last injection
+5 moreSecondary study objectives
Antibody titers measured by Hemagglutination Inhibition (HAI) Assay
Antibody titers measured by Seroneutralization (SN) test
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 3: High Dose Pandemic flu H5 mRNA vaccineExperimental Treatment1 Intervention
Participants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)
Group II: Group 2: Medium Dose Pandemic flu H5 mRNA vaccineExperimental Treatment1 Intervention
Participants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)
Group III: Group 1: Low Dose Pandemic flu H5 mRNA vaccineExperimental Treatment1 Intervention
Participants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)
Group IV: Group 4: PlaceboPlacebo Group1 Intervention
Participants will receive 2 injections of placebo 21 days apart (at Day 01 and Day 22)
Find a Location
Closest Location:Velocity Clinical Research, Springdale- Site Number : 8400010· Cincinnati, OH· 253 miles
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Sanofi Pasteur, a Sanofi CompanyLead Sponsor
428 Previous Clinical Trials
6,139,199 Total Patients Enrolled