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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 1, day 57 (1 month after dose 2), day 209 (6 months after dose 2), and day 394 (1 year after dose 2)
Awards & highlights

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.
Select...
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 1, day 57 (1 month after dose 2), day 209 (6 months after dose 2), and day 394 (1 year after dose 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 57 (1 month after dose 2), day 209 (6 months after dose 2), and day 394 (1 year after dose 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against Ancestral Strain
GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against SARS-CoV-2 Omicron Variant
GM Value of the Serum Ab Level Against Ancestral Strain Post BD
+11 more
Secondary outcome measures
GM Value of SARS-CoV-2 Spike Protein (S2P)-Specific Binding Antibody (bAb)
GM Value of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
GM Value of the Serum Ab Level After mRNA-1273 Vaccine Administration Against Circulating Strain
+7 more

Side effects data

From 2022 Phase 4 trial • 41 Patients • NCT04792567
25%
Hypertension
25%
Epilepsy
25%
Influenza like illness
25%
Peripheral swelling
25%
Urinary tract infection
25%
Headache
25%
Depression
25%
Blood pressure increased
25%
Chills
25%
Liver function test increased
25%
Pain in extremity
25%
Lymphopenia
25%
Blood glucose decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Siponimod Interrupted
DMT or No MS Treatment
Siponimod Continuous

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
~58730
mRNA-1273.222
2021
Completed Phase 3
~6280

Find a Location

Who is running the clinical trial?

Biomedical Advanced Research and Development AuthorityFED
85 Previous Clinical Trials
536,245 Total Patients Enrolled
16 Trials studying COVID-19
461,509 Patients Enrolled for COVID-19
ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,375,633 Total Patients Enrolled
37 Trials studying COVID-19
61,256,250 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
~945 spots leftby Jul 2025