SARS-CoV-2 study: MRNA-1283 vs MRNA-1273
Official title A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
ClinicalTrials.gov ID: NCT07808697
What this study is testing
What is mRNA-1283?
An investigational injectable biological being studied as a potential vaccine for SARS‑CoV‑2 in children and infants. It is designed to deliver messenger RNA that instructs cells to produce a piece of the virus spike protein, prompting an immune response.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find the best vaccine dose for different age groups and check how safe it is.
- Who it's for
- Healthy children and babies aged 6 months up to 11 years old.
- What's involved
- Participants will receive one of two vaccine doses and have blood tests to check their immune response.
- Time commitment
- The study involves several visits over a few months to monitor safety and immune response.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 11. Healthy volunteers may be eligible.
You may be able to join if
- Participant is male or female, between ≥2 years to \<12 years of age for Cohort 1 or ≥6 months to \<2 years of age for Cohort 2 (calculated from date...
- Participant is in good general health as determined by medical evaluation including medical history and physical examination.
- For participants in Cohort 2: the participant was born at ≥37 weeks, with a minimum birth weight of 2.5 kilograms, without fetal growth restriction.
- Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as premenarche.
- Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours before the study intervention.
You likely can't join if
- History of SARS-CoV-2 infection within 3 months prior to enrollment.
- Acutely ill or febrile (temperature ≥38.0℃elsius [100.4°Fahrenheit]) within 72 hours prior to or at the screening visit or Day 1.
- Any medical, psychiatric, or occupational condition, including reported history of drug, or alcohol abuse in the parent(s)/ legally authorized...
- Receipt of the 2026-2027 formulation of a COVID-19 vaccine at any time prior to enrollment.
- Receipt of any COVID-19 vaccine within 6 months prior to enrollment.
- Receipt of any nonstudy vaccination within 14 days (28 days for live vaccines) prior to study intervention or plans to receive a nonstudy vaccine...
See the full eligibility criteria
- Participant is male or female, between ≥2 years to \<12 years of age for Cohort 1 or ≥6 months to \<2 years of age for Cohort 2 (calculated from date of birth) at the time of signing the informed consent/assent.
- Participant is in good general health as determined by medical evaluation including medical history and physical examination.
- For participants in Cohort 2: the participant was born at ≥37 weeks, with a minimum birth weight of 2.5 kilograms, without fetal growth restriction.
- Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as premenarche.
- Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours before the study intervention.
- Is not currently chest/breastfeeding.
- Has been using a highly effective contraceptive method or has abstained from all activities that could lead to pregnancy for at least 28 days prior to the study injection (Day 1).
- Has agreed to continue adequate contraception through the end of study. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in...
- History of SARS-CoV-2 infection within 3 months prior to enrollment.
- Acutely ill or febrile (temperature ≥38.0℃elsius [100.4°Fahrenheit]) within 72 hours prior to or at the screening visit or Day 1.
- Any medical, psychiatric, or occupational condition, including reported history of drug, or alcohol abuse in the parent(s)/ legally authorized representative(s), that, in the opinion of the investigator, might pose...
- Receipt of the 2026-2027 formulation of a COVID-19 vaccine at any time prior to enrollment.
- Receipt of any COVID-19 vaccine within 6 months prior to enrollment.
- Receipt of any nonstudy vaccination within 14 days (28 days for live vaccines) prior to study intervention or plans to receive a nonstudy vaccine through 14 days after administration of study intervention.
- Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (for example, infliximab), within 180 days prior to Day 1 (baseline) or plans to do so during the...
- Received systemic immunoglobulins or blood products within 90 days prior to the screening visit or plans to receive them during the study. Exception: Nirsevimab and clesrovimab are allowed.
- For infants who receive breast milk, maternal receipt of systemic immunosuppressive therapy during lactation.
- Has participated in an treatment clinical study within 28 days prior to the screening visit based on the medical history interview or plans to do so while participating in this study.
- Has been placed under the control or protection of an agency, organization, institution, or entity by the courts, the government, or a government body, acting in accordance with powers conferred on them by laws, and...
- Receipt of any nonstudy vaccination within 14 days (28 days for live vaccines) prior to study intervention or plans to receive a nonstudy vaccine through 14 days after administration of study intervention.
- History of any myocarditis, pericarditis, or myopericarditis Note: Other inclusion and exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Ontario, California, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Tamarac, Florida, United States
- Southfield, Michigan, United States
- Beaumont, Texas, United States
- Brownsville, Texas, United States
- South Ogden, Utah, United States
- Richmond, Virginia, United States
- Ponce, Puerto Rico
- San Juan, Puerto Rico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 11 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ontario, California, United States; Miami, Florida, United States; Miami Lakes, Florida, United States; Tamarac, Florida, United States; Southfield, Michigan, United States; Beaumont, Texas, United States and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.