1860 Participants Needed

mRNA-1273.214 Vaccine for COVID-19 in Children

Recruiting at 67 trial locations
MC
MW
Overseen ByModerna WeCare Team
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like systemic immunosuppressants or immune-modifying drugs may affect eligibility if taken in the 6 months prior to enrollment. It's best to discuss your specific medications with the trial team.

Is the mRNA-1273.214 vaccine generally safe for humans?

The mRNA-1273.214 vaccine, also known as the Spikevax bivalent booster, has been studied in adults and shown to have a safety profile similar to previous COVID-19 vaccines, with most side effects being mild, such as injection site reactions and general body reactions like fatigue. Serious side effects were rare, and the vaccine's safety is consistent with other COVID-19 vaccines.12345

How is the mRNA-1273.214 vaccine different from other COVID-19 treatments?

The mRNA-1273.214 vaccine is unique because it is a bivalent booster, meaning it targets both the original COVID-19 virus and a variant, providing broader protection against multiple strains. This approach is different from earlier vaccines that targeted only the original virus.14567

What data supports the effectiveness of the mRNA-1273.214 drug for COVID-19 in children?

Research shows that bivalent vaccines like mRNA-1273.214, which target both the original and new variants of the virus, can produce strong and broad immune responses. These vaccines have been effective in increasing protection against various COVID-19 strains, including the Omicron variant, in both animal studies and human trials.14589

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My chronic condition (like asthma or diabetes) has been stable for at least 6 months.
I received two doses of the mRNA-1273 vaccine, 28-35 days apart, at least 4 months ago.
I am 2 years or older with a healthy weight, or under 2 with proper height and weight.
See 2 more

Exclusion Criteria

I haven't taken immune-suppressing drugs for more than 2 weeks in the last 6 months.
I have not been seriously ill or had a fever in the last 24 hours.
I have received a COVID-19 vaccine that is not mRNA-1273.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mRNA-1273.214 or mRNA-1273.815 vaccines as per their cohort assignment

4 weeks
2 visits (in-person)

Booster Dose Administration

Participants receive a booster dose of mRNA-1273.214 or mRNA-1273.815 vaccine

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity after vaccine administration

6 months
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • mRNA-1273.214
Trial Overview 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.
How Is the Trial Designed?
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.

mRNA-1273.214 is already approved in European Union, United Kingdom, United States for the following indications:

🇪🇺
Approved in European Union as mRNA-1273.214 for:
  • Prevention of COVID-19 caused by SARS-CoV-2 variants including Omicron BA.1 and BA.4/5
🇬🇧
Approved in United Kingdom as mRNA-1273.214 for:
  • Prevention of COVID-19 caused by SARS-CoV-2 variants including Omicron BA.1 and BA.4/5
🇺🇸
Approved in United States as mRNA-1273.214 for:
  • Prevention of COVID-19 caused by SARS-CoV-2 variants including Omicron BA.1 and BA.4/5

Find a Clinic Near You

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials
127
Recruited
66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel profile image

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Published Research Related to This Trial

A booster dose of the mRNA-1273 COVID-19 vaccine significantly increased neutralizing antibody levels against the original virus and key variants of concern, indicating enhanced immune response after waning immunity from the initial two-dose series.
Both the mRNA-1273 booster and variant-modified boosters were found to be safe and well-tolerated, suggesting they could be effective options for improving protection against emerging SARS-CoV-2 variants.
Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis.Choi, A., Koch, M., Wu, K., et al.[2021]
Bivalent vaccines encoding spike proteins from both the original Wuhan strain and Omicron variants (BA.1 or BA.4/5) induced broader neutralizing antibody responses in mice compared to monovalent vaccines, suggesting enhanced immunogenicity.
Boosting with these bivalent vaccines provided greater protection against BA.5 infection and reduced lung inflammation, indicating their potential effectiveness against currently circulating SARS-CoV-2 variants.
Bivalent SARS-CoV-2 mRNA vaccines increase breadth of neutralization and protect against the BA.5 Omicron variant.Scheaffer, SM., Lee, D., Whitener, B., et al.[2023]
The mRNA-1273 Covid-19 vaccine was found to be safe for children aged 6 months to 5 years, with mostly low-grade and transient adverse events, and no new safety concerns identified during the trial.
The vaccine elicited immune responses in young children that were comparable to those in young adults, meeting noninferiority criteria, with estimated efficacy rates of 36.8% for children aged 2-5 years and 50.6% for those aged 6-23 months against Covid-19.
Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age.Anderson, EJ., Creech, CB., Berthaud, V., et al.[2023]

Citations

Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis. [2021]
Bivalent SARS-CoV-2 mRNA vaccines increase breadth of neutralization and protect against the BA.5 Omicron variant. [2023]
Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age. [2023]
Safety, immunogenicity and antibody persistence of a bivalent Beta-containing booster vaccine against COVID-19: a phase 2/3 trial. [2023]
mRNA-1273 bivalent (original and Omicron) COVID-19 vaccine effectiveness against COVID-19 outcomes in the United States. [2023]
Evaluate the side effect associated with COVID-19 vaccine on adolescents in Riyadh, Saudi Arabia: A cross-section study. [2022]
Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ≥12 Years - United States, August 31-October 23, 2022. [2023]
Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age. [2023]
SARS-CoV-2 vaccines in children and adolescents: Can immunization prevent hospitalization? [2023]
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