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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 29 (28 days after each injection)
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new coronavirus vaccine in kids aged 6 months to 6 years old.

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.Check my eligibility
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.See study design
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.
Select...
I am 2 years or older with a healthy weight, or under 2 with proper height and weight.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 29 (28 days after each injection)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 29 (28 days after each injection) 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 of the Serum Ab Level against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration at Day 29
GM of the Serum Ab Level against Omicron XBB.1.5 after mRNA-1273.815 Administration
Geometric Mean (GM) of the Serum Antibody (Ab) Level against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration at Day 57
+7 more
Secondary outcome measures
GM of the Serum Ab Level against Omicron XBB.1.5 after mRNA-1273.815 Administration Regardless of prior SARS-CoV-2 Infection
SRR against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration Regardless of prior SARS-CoV-2 Infection
SRR against Omicron XBB.1.5 after mRNA-1273.815 Administration Regardless of prior SARS-CoV-2 Infection

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
mRNA-1273.815
2021
Completed Phase 3
~5410
Moderna COVID-19 Vaccine
FDA approved

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,376,265 Total Patients Enrolled
37 Trials studying COVID-19
61,258,706 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 1), mRNA-1273.214 (Part 2), mRNA-1273.815 (Part 3), mRNA-1273.815 (Part 4)
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

Frequently Asked Questions

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

How many people are being selected for this clinical trial?

"The information available on clinicaltrials.gov suggests that this trial is still open to recruiting patients. This particular trial was posted on 6/21/2022 and updated as recently as 10/8/2022. So far, 960 people have been recruited from 28 different locations."

Answered by AI

Could you please elucidate the possible dangers of mRNA-1273.214 for human beings?

"There is some evidence that suggests the efficacy of mRNA-1273.214 and it has undergone multiple rounds of testing, so we believe it to be safe and have rated it a 3 on our Power scale."

Answered by AI

Are there any patients that this experiment is still recruiting?

"Yes, this trial is still recruiting patients as of October 8th, 2022. The clinical study was first posted on June 21st, 2020."

Answered by AI

Does this trial cater to young adults or is it open to people of all ages?

"Children aged 6 months to 5 years old can be enrolled in this clinical trial. Out of the 196 total trials, 31 are for drugs targeting pediatric patients and 165 cater to an elderly demographic."

Answered by AI
~837 spots leftby Oct 2025