Part 2: mRNA-1010 for COVID-19
Phase-Based Progress Estimates
Effectiveness
Safety
Tekton Research, Inc, Austin, TX
COVID-19+5 More
mRNA-1010 - BiologicalEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary
The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.
Eligible Conditions
- COVID-19
- Cytomegalovirus (CMV)
- Coronavirus Disease 2019 (COVID‑19)
- Respiratory Syncytial Virus (RSV)
- Seasonal Influenza
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 6 Secondary · Reporting Duration: Days 1 (Baseline), 29, 85, and 197
Day 29
Geometric Mean Fold-Rise (GMFR) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
Geometric Mean Titer (GMT) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
Percentage of Participants With Seroresponse for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
Day 529
Number of Participants With Serious AEs (SAEs), AEs of Special Interest (AESIs), Medically-Attended Adverse Events (MAAEs), and AEs Leading to Study Withdrawal or Discontinuation of Study Vaccination
Day 1
GMFR of Serum Neutralizing Antibody Response for mRNA-1647
GMT of Serum Neutralizing Antibody Response for mRNA-1647
Percentage of Participants With Seroresponse for mRNA-1647
Day 176
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Day 197
Number of Participants With Unsolicited Adverse Events (AEs)
Trial Safety
Safety Progress
Trial Design
6 Treatment Groups
Part 2: FLUAD®
1 of 6
Part 2: mRNA-1010
1 of 6
Part 1: mRNA-1647 2-Dose
1 of 6
Part 1: mRNA-1345
1 of 6
Part 2: mRNA-1273
1 of 6
Part 1: mRNA-1647 3-Dose
1 of 6
Active Control
Experimental Treatment
300 Total Participants · 6 Treatment Groups
Primary Treatment: Part 2: mRNA-1010 · No Placebo Group · Phase 1
Part 2: mRNA-1010
Biological
Experimental Group · 1 Intervention: mRNA-1010 · Intervention Types: BiologicalPart 1: mRNA-1647 2-Dose
Biological
Experimental Group · 1 Intervention: mRNA-1647 · Intervention Types: BiologicalPart 1: mRNA-1345
Biological
Experimental Group · 1 Intervention: mRNA-1345 · Intervention Types: BiologicalPart 2: mRNA-1273
Biological
Experimental Group · 1 Intervention: mRNA-1273 · Intervention Types: BiologicalPart 1: mRNA-1647 3-Dose
Biological
Experimental Group · 1 Intervention: mRNA-1647 · Intervention Types: BiologicalPart 2: FLUAD®
Biological
ActiveComparator Group · 1 Intervention: FLUAD® · Intervention Types: BiologicalTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1273
2021
Completed Phase 4
~340
mRNA-1647
2017
Completed Phase 1
~190
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: days 1 (baseline), 29, 85, and 197
Closest Location: Tekton Research, Inc · Austin, TX
2011First Recorded Clinical Trial
1 TrialsResearching COVID-19
8 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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