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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Received corticosteroids at ≥10 milligram (mg)/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study
Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14 up to end of season (up to approximately day 181)
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial aims to test the safety and effectiveness of mRNA-1010 compared to another flu vaccine in preventing flu-like illness caused by different types of flu viruses.
Who is the study for?
This trial is for adults aged 50 years or older. It's designed to test the safety and effectiveness of a new flu vaccine called mRNA-1010 compared to licensed flu vaccines like Fluarix® and Influsplit®.
What is being tested?
The study compares the new mRNA-1010 vaccine with established influenza vaccines. Participants will receive one type of vaccine and be monitored for their body's reaction and protection against flu-like symptoms caused by influenza A or B.
What are the potential side effects?
Possible side effects may include typical reactions at the injection site, such as pain, redness, swelling, as well as general symptoms like fever, fatigue, headache, muscle aches.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have taken high-dose steroids recently or might need them during the study.
Select...
I have a history of immune system problems or frequent severe infections.
Select...
I haven't taken immune-weakening medicines in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 14 up to end of season (up to approximately day 181)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14 up to end of season (up to approximately day 181)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to First Episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Confirmed Protocol Defined ILI
Secondary study objectives
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI)
HAI Titer
Number of Participants with First Episode of RT-PCR Confirmed Modified US Centers for Disease Control and Prevention (CDC)-Defined ILI
+2 moreSide effects data
From 2023 Phase 3 trial • 6102 Patients • NCT0541546214%
COVID-19
7%
Upper respiratory tract infection
6%
Influenza like illness
5%
Rhinovirus infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluarix Quadrivalent 60 ug
mRNA-1010 50 ug
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: mRNA-1010Experimental Treatment1 Intervention
Participants will receive a single injection of mRNA-1010 on Day 1.
Group II: Fluarix® or Influsplit®Active Control2 Interventions
Participants will receive a single injection of active comparator (Fluarix® or Influsplit®) on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1010
2022
Completed Phase 3
~40020
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Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
117 Previous Clinical Trials
61,529,241 Total Patients Enrolled
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