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Vaccine

mRNA-1273 Vaccine for COVID-19 in Adolescents (TeenCove Trial)

Verified Trial
Phase 2 & 3
Waitlist Available
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has your child not received a COVID-19 vaccine?
Has your child not tested positive for COVID-19 or had close contact with someone who has tested positive for COVID-19 in the past two weeks?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 43 up to day 394

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your child has not yet received a COVID-19 vaccine.
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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.
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Is your child currently healthy?
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Is your child between 12 and 17 years old?
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Has your child stayed in the United States for the last month without traveling abroad?
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Your child cannot participate if they had a vaccine or were in a clinical trial within the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 43 up to day 394
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 43 up to day 394 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Serum Antibody (Ab) Levels that Meet or Exceed the Threshold of Protection From COVID-19
Secondary study objectives
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

Side effects data

From 2022 Phase 4 trial • 41 Patients • NCT04792567
24%
COVID-19
18%
Lymphopenia
18%
Injection site pain
12%
Liver function test increased
12%
Pain in extremity
12%
Multiple sclerosis relapse
6%
Escherichia urinary tract infection
6%
Visual impairment
6%
Fatigue
6%
Pyrexia
6%
Injection site pustule
6%
Rhinitis
6%
Urinary tract infection
6%
Upper limb fracture
6%
Back pain
6%
Myalgia
6%
Dizziness
6%
Headache
6%
VIth nerve paralysis
6%
Menstrual disorder
6%
Cough
6%
Flushing
100%
80%
60%
40%
20%
0%
Study treatment Arm
Siponimod Continuous
Siponimod Interrupted
DMT or No MS Treatment

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: mRNA-1273.222Experimental Treatment1 Intervention
Part 3 (Open-Label): Participants will receive up to 2 IM injections of mRNA-1273.222 (50 ug each), 6 months apart, on Day 1 and Day 181.
Group II: mRNA-1273 BDExperimental Treatment1 Intervention
Part 1C-1 (BD Phase): Participants will receive 1 IM injection of mRNA-1273 (50 ug) on BD-Day 1, 5 months after the last dose of Part 1A and 1B. Part 1C-2 (BD Phase): Participants will receive 1 IM injection of mRNA-1273 (50 ug) on BD-Day 1, at least 3 months post-last dose.
Group III: mRNA-1273Experimental Treatment1 Intervention
Part 1A (Blinded Phase): Participants will receive 2 intramuscular (IM) injections of mRNA-1273 (100 microgram \[ug\] each), 28 days apart, on Day 1 and Day 29. Part 1B (Open-Label Phase): Participants who cross over from placebo in Part 1A to Part 1B will receive 2 IM injections of mRNA-1273 (100 ug each), 28 days apart on Open Label Day 1 and Open Label Day 29. Part 2 (Open-Label): Participants will receive 2 IM injections of mRNA-1273 (50 ug each), 28 days apart, on Day 1 and Day 29 and may receive a booster dose on Day 149.
Group IV: PlaceboPlacebo Group1 Intervention
Part 1A (Blinded Phase): Participants will receive 2 IM injections of mRNA-1273 matching placebo, 28 days apart, on Day 1 and Day 29.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1273
2021
Completed Phase 4
~58720
mRNA-1273.222
2021
Completed Phase 3
~6280

Find a Location

Who is running the clinical trial?

Biomedical Advanced Research and Development AuthorityFED
92 Previous Clinical Trials
549,321 Total Patients Enrolled
16 Trials studying COVID-19
471,709 Patients Enrolled for COVID-19
ModernaTX, Inc.Lead Sponsor
116 Previous Clinical Trials
61,463,130 Total Patients Enrolled
39 Trials studying COVID-19
61,259,744 Patients Enrolled for COVID-19

Media Library

mRNA-1273 (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04649151 — Phase 2 & 3
COVID-19 Research Study Groups: mRNA-1273, Placebo, mRNA-1273 BD, mRNA-1273.222
COVID-19 Clinical Trial 2023: mRNA-1273 Highlights & Side Effects. Trial Name: NCT04649151 — Phase 2 & 3
mRNA-1273 (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04649151 — Phase 2 & 3
COVID-19 Patient Testimony for trial: Trial Name: NCT04649151 — Phase 2 & 3
~896 spots leftby Oct 2025
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