Verified

mRNA-1273 for COVID-19

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Us Army Medical Research Directorate-Africa , Kenya Medical Research Institute Clinical Research Center, Kisumu, KenyaCOVID-19mRNA-1273 - Biological
Eligibility
12 - 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a vaccine to prevent COVID-19. It will study how safe and effective it is in adolescents, and will also study an optional booster dose.

Eligible Conditions
  • COVID-19

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

24 Primary · 22 Secondary · Reporting Duration: Part 3: Days 29 and 209

28 days post-vaccination
Part A and C: Number of Participants with Unsolicited Adverse Events (AEs)
7 days post-vaccination
Part A and C: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Day 361
Part C: GM of the Serum Ab Level of Circulating Strain Post BD
Part C: SRR of Vaccine Recipients of Circulating Strain Post BD
BD-Day 29
GM Value of the Serum Ab Level of Original Strain Post BD
GM of the Serum Ab Level of Original Strain Post BD
Part C: GM of the Serum Ab Level of Original Strain Post BD
Part C: SRR of Vaccine Recipients of Original Strain Post BD
SRR of Vaccine Recipients of Original Strain Post BD
Day 57
GM of the Serum Ab Level of Circulating Strain
SRR of Vaccine Recipients of Circulating Strain
Year 1
GM Value of SARS-CoV-2 Spike Protein (S2P)-Specific Binding Antibody (bAb)
GM Value of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
GM of SARS-CoV-2 Spike Protein (S2P)-Specific Binding Antibody (bAb)
GM of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
Part A: GM of SARS-CoV-2 Spike Protein (S2P)-Specific Binding Antibody (bAb)
Part A: GM of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
Day 394
Number of Participants With Asymptomatic SARS-CoV-2 Infection Measured by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein
Number of Participants with a First Occurrence of Symptomatic COVID-19 Starting 14 days After Second Dose of mRNA-1273 or Placebo
Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic) Starting 14 Days after the Second Dose of mRNA-1273 or Placebo
Part A: Number of Participants With Asymptomatic SARS-CoV-2 Infection Measured by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein
Part A: Number of Participants with a First Occurrence of Symptomatic COVID-19 Starting 14 days After Second Dose of mRNA-1273 or Placebo
Part A: Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic) Starting 14 Days after the Second Dose of mRNA-1273 or Placebo
Day 57
Geometric Mean (GM) Value of the Serum Ab Level
Geometric Mean (GM) of the Serum Ab Level
Number of Participants With Serum Antibody (Ab) Levels that Meet or Exceed the Threshold of Protection From COVID-19
Part A: Geometric Mean (GM) of the Serum Ab Level
Part A: Number of Participants With Serum Antibody (Ab) Levels that Meet or Exceed the Threshold of Protection From COVID-19
Part A: Seroresponse Rate (SRR) of Vaccine Recipients
Seroresponse Rate (SRR) of Vaccine Recipients
Seroresponse Rate of Vaccine Recipients
Day 29
GM Value of the Serum Ab Level After mRNA-1273 Vaccine Administration Against Circulating Strain
SRR After mRNA-1273 Vaccine Administration Against Circulating Strain
Part 3: Day 209
GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against SARS-CoV-2 Omicron Variant at Day 209
Part 3: Day 29
GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against SARS-CoV-2 Omicron Variant at Day 29
Day 29
GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against Original Strain
GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against Other Variants of Interest
SRR After mRNA-1273.222 Vaccine Administration Against Omicron Variant
SRR After mRNA-1273.222 Vaccine Administration Against Original Strain
Up to BD-Day 361
Part C: Number of Participants with AEs Leading to the Discontinuation From Study Post BD
Day 29
Number of Participants with Unsolicited Adverse Events (AEs)
Up to Day 394
Part A and C: Number of Participants with Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), or Adverse Events of Special Interest (AESI)
Year 1
Number of Participants with Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), or Adverse Events of Special Interest (AESI) of Multisystem Inflammatory Syndrome in Children (MIS-C)
Up to Day 751
Number of Participants with AEs Leading to the Discontinuation From Study Post BD
Number of Participants with Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), or Adverse Events of Special Interest (AESI)
Day 8
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

mRNA-1273
1 of 4
mRNA-1273 BD
1 of 4
mRNA-1273.222
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

4431 Total Participants · 4 Treatment Groups

Primary Treatment: mRNA-1273 · Has Placebo Group · Phase 2 & 3

mRNA-1273
Biological
Experimental Group · 1 Intervention: mRNA-1273 · Intervention Types: Biological
mRNA-1273 BD
Biological
Experimental Group · 1 Intervention: mRNA-1273 · Intervention Types: Biological
mRNA-1273.222
Biological
Experimental Group · 1 Intervention: mRNA-1273.222 · Intervention Types: Biological
Placebo
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moderna COVID-19 Vaccine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: part 3: days 29 and 209

Who is running the clinical trial?

Biomedical Advanced Research and Development AuthorityFED
63 Previous Clinical Trials
96,677 Total Patients Enrolled
10 Trials studying COVID-19
34,560 Patients Enrolled for COVID-19
ModernaTX, Inc.Lead Sponsor
72 Previous Clinical Trials
50,286,592 Total Patients Enrolled
19 Trials studying COVID-19
50,065,157 Patients Enrolled for COVID-19

Eligibility Criteria

Age 12 - 18 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your child has not yet received a COVID-19 vaccine.
Your child has not been diagnosed with COVID-19 or been in close contact with someone who has had COVID-19 in the last two weeks.
Is your child currently healthy?
Is your child between 12 and 17 years old?
Has your child stayed in the United States for the last month without traveling abroad?
Your child cannot participate if they had a vaccine or were in a clinical trial within the last month.

Who else is applying?

What state do they live in?
Florida29.5%
Illinois15.9%
Georgia11.4%
Other43.2%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria84.1%
Met criteria15.9%
Why did patients apply to this trial?
  • "I was curious about new vaccines"
  • "Want more research on covid and how to prevent it"
  • "I feel there is an importance in helping out science."
  • "Interested in participating in a trial. Just the name power is motivating."
  • "I'm behind on my vaccines and would like to help test new vaccine if I am able"
How many prior treatments have patients received?
076.9%
111.5%
23.8%
3+7.7%
What questions have other patients asked about this trial?
  • "Are there any sites near me?"
  • "What trials are available for me?"
What site did they apply to?
Medpharmics - Albuquerque50.0%
Alliance for Multispecialty Research, LLC50.0%

How responsive is this trial?

Typically responds via
Email100.0%

Frequently Asked Questions

Is this clinical trial being conducted in multiple locations within the city?

"There are many locations participating in this clinical trial, but a few notable ones are Cottonwood Pediatrics in Hastings, Nebraska, Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS in Omaha, South Carolina, and Meridian Clinical Research - Charleston, SC in Charleston." - Anonymous Online Contributor

Unverified Answer

Does this research involve any participants who are octogenarians or younger?

"This study is meant for children aged 12 to 18. Out of the 1,144 total clinical trials, this one falls in the 146 trials catering to those under 18 years old." - Anonymous Online Contributor

Unverified Answer

Is this research looking for new participants at the moment?

"Unfortunately, this particular study is not currently looking for participants. Although, it's worth noting that the trial was most recently updated on October 25th, 2020. There are 1119 other trials actively recruiting patients with covid-19 and 28 studies for mRNA-1273 that are still looking for volunteers." - Anonymous Online Contributor

Unverified Answer

What are the requirements for participants in this experiment?

"This clinical trial is recruiting 3931 people with covid-19 aged 12 and 18. Most importantly, applicants should meet the following criteria: • Participants 12 to <18 years of age at the time of consent (Screening Visit, Day 0) who, in the opinion of the Investigator, are in good general health based on review of medical history and screening physical examination., • Investigator assessment that the participant, in the case of an emancipated minor, or parent(s)/legally acceptable representative(s) [LAR(s)] understand and is willing and physically able to comply with protocol-" - Anonymous Online Contributor

Unverified Answer

How many guinea pigs are a part of this experiment?

"This trial is no longer recruiting patients. It was initially posted on December 9th, 2020 and last updated on October 25th, 2022. However, there are 1119 other trials related to covid-19 that are still admitting participants and 28 mRNA-1273 trials that are also currently enrolling patients." - Anonymous Online Contributor

Unverified Answer

Is this research project something new?

"Since 2020, mRNA-1273 has undergone extensive clinical trials. The first was sponsored by ModernaTX and took place in the same year. After involving 120 patients, it received Phase 1 approval in 2020. Currently, there are 28 active studies being conducted for this medication across 219 cities and 22 countries worldwide." - Anonymous Online Contributor

Unverified Answer

Are there other research projects that have used the mRNA-1273 vaccine?

"mRNA-1273 was first trialed in 2020 by the Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases. So far, a total of 18295 completed trials have been conducted. There are presently 28 live clinical trials, with a large number taking place in Hastings, Nebraska." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.