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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
Study Summary
This trial is testing the safety and effectiveness of three different vaccines against the flu.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 • NCT0533328949%
Injection site pain
25%
Fatigue
23%
Headache
20%
Arthralgia
15%
Myalgia
14%
Injection site lymphadenopathy
11%
Chills
10%
Vomiting
7%
COVID-19
4%
Rhinovirus infection
3%
Oropharyngeal pain
3%
Injection site erythema
3%
Injection site induration
3%
Upper respiratory tract infection
1%
Sinusitis
1%
Cough
1%
Splenic rupture
1%
Accidental overdose
1%
Haemoglobin decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Flublok
mRNA-1020 Dose Level A
mRNA-1010
mRNA-1030 Dose Level A
mRNA-1030 Dose Level B
mRNA-1020 Dose Level B
mRNA-1030 Dose Level C
mRNA-1020 Dose Level C
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
108 Previous Clinical Trials
61,378,745 Total Patients Enrolled
Frequently Asked Questions
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