mRNA-1283 for COVID-19
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to find the best dose of a new COVID-19 vaccine, mRNA-1283, for children aged 6 months to under 12 years. Researchers will test two different doses and compare them to the existing COVID-19 vaccine, mRNA-1273, to determine which is most effective. The trial seeks generally healthy children, including those with stable conditions like asthma. Participants should not have had COVID-19 recently or received a COVID-19 vaccine in the last six months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important vaccine development.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the mRNA-1283 vaccine for COVID-19 is generally well tolerated. Participants in studies experienced fewer side effects compared to the earlier mRNA-1273 version. Common reactions were mild, including sore arms or brief fatigue.
For mRNA-1273, evidence indicates it is safe for teenagers. Most side effects were also mild, such as pain at the injection site or a brief fever. These findings suggest that both vaccines are safe for children in the age groups under study.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the mRNA-1283 treatment for COVID-19 because it aims to provide enhanced immune protection with potentially fewer doses than existing vaccines like mRNA-1273 (Moderna's original COVID-19 vaccine). Unlike the standard vaccines that may require booster shots to maintain efficacy, mRNA-1283 is designed to target multiple parts of the virus, which could lead to longer-lasting immunity and better protection against variants. This next-generation vaccine uses a similar mRNA technology but is optimized to be more stable and easier to store, which could simplify distribution and accessibility.
What evidence suggests that this trial's treatments could be effective for COVID-19?
Research has shown that the mRNA-1283 COVID-19 vaccine, which participants in this trial may receive, delivers promising results. It triggers a stronger immune response than the earlier version, mRNA-1273, also under study in this trial. In previous trials, mRNA-1283 provided strong protection against COVID-19, particularly against variants like Omicron. Studies found that mRNA-1273 was highly effective, preventing symptomatic COVID-19 in 94% of cases. These findings suggest that both vaccines effectively boost immunity, with mRNA-1283 possibly offering even better protection.678910
Are You a Good Fit for This Trial?
This trial is for children ages 6 months to under 12 years who are generally healthy and want to participate in research on COVID-19 vaccines. Children with certain health conditions or recent vaccinations may not be able to join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mRNA-1283 or mRNA-1273 doses according to cohort assignment
Follow-up
Participants are monitored for safety and immunogenicity after receiving the doses
What Are the Treatments Tested in This Trial?
Interventions
- mRNA-1273
- mRNA-1283
Trial Overview
The study is testing two different doses of a new COVID-19 vaccine (mRNA-1283) compared to an existing one (mRNA-1273) in young children, aiming to find the best dose that works safely and effectively.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Active Control
Participants aged 6 months to \<2 years receive two IM doses of 28 days apart (Days 1 and 29).
Participants aged 6 months to \<2 years receive two IM doses 28 days apart (Days 1 and 29).
Participants aged 2 to \<12 years receive one IM dose of on Day 1.
Participants aged 2 to \<12 years receive one IM dose of on Day 1.
Participants aged 2 to \<12 years receive one IM dose of on Day 1.
Participants aged 6 months to \<2 years receive two IM doses 28 days apart (Day 1 and 29).
Find a Clinic Near You
Who Is Running the Clinical Trial?
ModernaTX, Inc.
Lead Sponsor
Dr. Stephen Hoge
ModernaTX, Inc.
Chief Medical Officer
MD from Harvard Medical School
Stéphane Bancel
ModernaTX, Inc.
Chief Executive Officer since 2011
MBA from Harvard Business School, MSc in Engineering from École Centrale Paris
Citations
1.
contagionlive.com
contagionlive.com/view/moderna-demonstrates-positive-results-from-phase-3-trial-of-its-next-generation-covid-19-vaccineModerna Demonstrates Positive Results from Phase 3 Trial ...
mRNA-1283, induced a more robust immune response compared to its previous COVID-19 vaccine, , headache, fatigue, myalgia, and chills.
A Study of mRNA-1283 Injection Compared With mRNA-1273 ...
The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity ...
3.
contagionlive.com
contagionlive.com/view/moderna-vaccine-significant-covid-19-prevention-efficacy-phase-3-dataModerna Vaccine Shows Significant COVID-19 Prevention ...
The prevention of symptomatic SARS-CoV-2 infection with mRNA-1273 versus placebo was observed at 94.1% efficacy (95% CI, 89.3-96.8; P <.001).
Efficacy and Safety of mRNA-1273 SARS-CoV-2 Vaccine
Preliminary data indicated high efficacy of an mRNA-based vaccine developed in collaboration between Moderna and the NIAID.
The Safety and Effectiveness of mRNA Vaccines Against ...
Another study has shown that the mRNA-1273 vaccine had high efficacy in immunocompromised patients with SARS-CoV-2 infections [46]. According to ...
Efficacy, immunogenicity, and safety of a next-generation
Primary objectives comparing. mRNA-1283 with mRNA-1273 were non-inferior rVE to prevent a first event of COVID-19 from 14 days after study.
mRNA-1283 Vaccine for COVID-19
Research shows that the mRNA-1283 vaccine for COVID-19 is generally well tolerated and safer than the earlier mRNA-1273 version. Most participants experienced ...
Safety Data Sheet
No data identified for mRNA-1283 (drug substance). As a ribonucleotide it is not expected to be genotoxic. For another chemically similar ...
NCT04470427 | A Study to Evaluate Efficacy, Safety, and ...
The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of ...
Safety and durability of mRNA-1273–induced SARS-CoV-2 ...
The overall risk–benefit profile of mRNA-1273 remains favorable in adolescents, with durable 12-month immune responses against SARS-CoV-2 (ancestral/variants).
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