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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 8 and 181
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing three new mRNA vaccines to see if they are safe and effective in protecting people against the flu. The vaccines aim to help those who might not respond well to regular flu shots by teaching their immune systems to fight the virus.
Eligible Conditions
- Flu
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 8 and 181
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 8 and 181
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains
+6 moreSecondary study objectives
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Side effects data
From 2022 Phase 1 & 2 trial • 572 Patients • NCT0533328993%
Injection site pain
75%
Fatigue
71%
Myalgia
68%
Headache
57%
Chills
56%
Arthralgia
39%
Injection site lymphadenopathy
22%
Vomiting
14%
Pyrexia
11%
Injection site induration
8%
Injection site erythema
7%
COVID-19
3%
Alanine aminotransferase increased
3%
Oropharyngeal pain
3%
Anxiety
1%
Ischaemic stroke
1%
Hip fracture
1%
Upper respiratory tract infection
1%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
mRNA-1030 Dose Level C
mRNA-1030 Dose Level A
Flublok
mRNA-1020 Dose Level A
mRNA-1030 Dose Level B
mRNA-1020 Dose Level C
mRNA-1020 Dose Level B
mRNA-1010
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: mRNA-1030 Dose Level CExperimental Treatment1 Intervention
Participants will receive mRNA-1030 at Dose Level C by IM injection on Day 1.
Group II: mRNA-1030 Dose Level BExperimental Treatment1 Intervention
Participants will receive mRNA-1030 at Dose Level B by IM injection on Day 1.
Group III: mRNA-1030 Dose Level AExperimental Treatment1 Intervention
Participants will receive mRNA-1030 at Dose Level A by intramuscular (IM) injection on Day 1.
Group IV: mRNA-1020 Dose Level CExperimental Treatment1 Intervention
Participants will receive mRNA-1020 at Dose Level C by IM injection on Day 1.
Group V: mRNA-1020 Dose Level BExperimental Treatment1 Intervention
Participants will receive mRNA-1020 at Dose Level B by IM injection on Day 1.
Group VI: mRNA-1020 Dose Level AExperimental Treatment1 Intervention
Participants will receive mRNA-1020 at Dose Level A by IM injection on Day 1.
Group VII: Active ComparatorActive Control1 Intervention
Participants will receive an active comparator by IM injection on Day 1.
Group VIII: mRNA-1010Active Control1 Intervention
Participants will receive mRNA-1010 by IM injection on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1030
2022
Completed Phase 2
~580
mRNA-1020
2022
Completed Phase 2
~580
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
118 Previous Clinical Trials
61,584,667 Total Patients Enrolled
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