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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

TeenCove Trial 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.

TeenCove Trial Eligibility Criteria

Inclusion Criteria

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

TeenCove Trial 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 3 trial • 2013 Patients • NCT05047770
82%
Injection site pain
67%
Myalgia
58%
Fatigue
52%
Headache
43%
Chills
42%
Arthralgia
25%
Diarrhoea
25%
Injection site pruritus
23%
Nausea
18%
Injection site erythema
15%
Lymphadenopathy
14%
Abdominal pain
11%
Pyrexia
9%
Injection site swelling
4%
Vomiting
2%
Upper respiratory tract infection
1%
Nasopharyngitis
1%
Nephrolithiasis
1%
Constipation
1%
COVID-19
1%
Fall
1%
Sneezing
1%
Dermatitis contact
1%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
HZ/suSeq Group
HZ/suCoAd Group
FluD-QIVCoAd Group
FluD-QIVSeq Group

TeenCove 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
~46340
mRNA-1273.222
2021
Completed Phase 3
~6280

Find a Location

Who is running the clinical trial?

Biomedical Advanced Research and Development AuthorityFED
79 Previous Clinical Trials
904,552 Total Patients Enrolled
16 Trials studying COVID-19
461,094 Patients Enrolled for COVID-19
ModernaTX, Inc.Lead Sponsor
105 Previous Clinical Trials
61,363,233 Total Patients Enrolled
35 Trials studying COVID-19
61,245,714 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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-"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Illinois
Florida
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+
1
0
What site did they apply to?
Accel Research Sites - Nona Pediatric Center
Velocity Clinical Research - Boise
Medpharmics - Albuquerque
Other

Why did patients apply to this trial?

I was curious about new vaccines. Want more research on covid and how to prevent it.
PatientReceived 1 prior treatment
I feel there is an importance in helping out science. I'm behind on my vaccines and would like to help test new vaccine if I am able.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Are there any sites near me? What trials are available for me?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
~206 spots leftby Jun 2024