Part 2: mRNA-1010 for COVID-19

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tekton Research, Inc, Austin, TX
COVID-19+5 More
mRNA-1010 - Biological
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

1 of 3

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

1 of 3

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: Biological
Part 1: mRNA-1647 2-Dose
Biological
Experimental Group · 1 Intervention: mRNA-1647 · Intervention Types: Biological
Part 1: mRNA-1345
Biological
Experimental Group · 1 Intervention: mRNA-1345 · Intervention Types: Biological
Part 2: mRNA-1273
Biological
Experimental Group · 1 Intervention: mRNA-1273 · Intervention Types: Biological
Part 1: mRNA-1647 3-Dose
Biological
Experimental Group · 1 Intervention: mRNA-1647 · Intervention Types: Biological
Part 2: FLUAD®
Biological
ActiveComparator Group · 1 Intervention: FLUAD® · Intervention Types: Biological
Treatment
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
Photo of Austin  1Photo of Austin  2Photo of Austin  3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.