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Virus Vaccine

mRNA-1273.214 Vaccine for COVID-19 in Children

Phase 3
Recruiting
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with chronic diseases (asthma, diabetes mellitus, cystic fibrosis, HIV infection) must have stable disease status for at least 6 months prior to Screening Visit
Participant must be 2 years or older with a BMI at or above the 2nd percentile according to WHO Child Growth Standards, or less than 2 years with height and weight at or above the 2nd percentile
Must not have
Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to enrollment
Acutely ill or febrile 24 hours prior to or at the Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
No Placebo-Only Group

Summary

This trial tests updated COVID-19 vaccines on young children. The vaccines use mRNA to teach the body to recognize and fight the virus. The study aims to ensure these vaccines are safe and effective for this age group.

Who is the study for?
Healthy children aged 6 months to less than 6 years, with normal growth standards, who have either not received a COVID-19 vaccine or had two doses of mRNA-1273 at least four months prior. Children with stable chronic diseases can join. Those acutely ill, febrile, or previously infected with SARS-CoV-2 within the last 90 days are excluded.
What is being tested?
The trial is testing the safety and immune response to the mRNA-1273.214 COVID-19 vaccine in young children. It involves two parts: one for those who haven't been vaccinated and another for those previously given two doses of mRNA-1273 as a primary series.
What are the potential side effects?
Possible side effects include typical reactions at the injection site like pain and swelling, fever, fatigue, headache, muscle pain, chills and nausea. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My chronic condition (like asthma or diabetes) has been stable for at least 6 months.
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I am 2 years or older with a healthy weight, or under 2 with proper height and weight.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken immune-suppressing drugs for more than 2 weeks in the last 6 months.
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I have not been seriously ill or had a fever in the last 24 hours.
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I have received a COVID-19 vaccine that is not mRNA-1273.
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I haven't had any vaccines 14 days before or plan to within 14 days after the study vaccine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 2 & 3 trial • 3548 Patients • NCT05249829
8%
COVID-19
4%
Upper respiratory tract infection
2%
Headache
2%
Nasal congestion
1%
Cough
1%
Asymptomatic COVID-19
1%
Myocardial infarction
1%
Fatigue
1%
Nasopharyngitis
1%
Arthralgia
1%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: mRNA-1273.529
Part 1: mRNA-1273
Part 2: mRNA-1273
Part 2: mRNA-1273.214

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: mRNA-1273.815 (Part 4)Experimental Treatment1 Intervention
Participants in Part 4 Cohort A will receive a single IM injection of mRNA-1273.815 vaccine on Day 1. Participants in Part 4 Cohort B will receive IM injections of mRNA-1273.815 vaccine on Day 1 and Day 29.
Group II: mRNA-1273.815 (Part 3)Experimental Treatment1 Intervention
Participants who have previously been vaccinated with an authorized/approved COVID-19 vaccine, will receive a single IM BD of mRNA-1273.815 vaccine on BD Day 1, at least 4 months after the last dose of a COVID-19 vaccine.
Group III: mRNA-1273.214 (Part 2)Experimental Treatment1 Intervention
Participants who have previously been vaccinated with a mRNA-1273 primary series, will receive a single IM BD of mRNA-1273.214 vaccine at least 4 months after completion of the mRNA-1273 primary series.
Group IV: mRNA-1273.214 (Part 1)Experimental Treatment1 Intervention
Participants who have not been previously vaccinated against SARS-CoV-2, will receive 2 intramuscular (IM) injections of mRNA-1273.214 vaccine on Day 1 and Day 29.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moderna COVID-19 Vaccine
FDA approved
mRNA-1273.815
2021
Completed Phase 3
~5410

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for COVID-19 include antiviral drugs like remdesivir, which inhibits viral replication, and immunomodulators like dexamethasone, which reduce inflammation. mRNA vaccines, such as mRNA-1273.214 and mRNA-1273.815, work by encoding the spike protein of SARS-CoV-2, prompting the body to produce an immune response. This mechanism is crucial as it prepares the immune system to recognize and combat the virus effectively, reducing the severity of the disease and preventing infection. These treatments are vital for COVID-19 patients as they target different aspects of the virus's life cycle and the body's response, offering a multi-faceted approach to managing and preventing the disease.
Prevalence and outcome of COVID-19 among Iranian celiac patients.Current Therapeutics for COVID-19, What We Know about the Molecular Mechanism and Efficacy of Treatments for This Novel Virus.Antimicrobial peptides: features, applications and the potential use against covid-19.

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
120 Previous Clinical Trials
61,586,349 Total Patients Enrolled
41 Trials studying COVID-19
61,382,445 Patients Enrolled for COVID-19

Media Library

mRNA-1273.214 (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05436834 — Phase 3
COVID-19 Research Study Groups: mRNA-1273.214 (Part 2), mRNA-1273.815 (Part 4), mRNA-1273.815 (Part 3), mRNA-1273.214 (Part 1)
COVID-19 Clinical Trial 2023: mRNA-1273.214 Highlights & Side Effects. Trial Name: NCT05436834 — Phase 3
mRNA-1273.214 (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05436834 — Phase 3
~465 spots leftby Oct 2025