Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mRNA-1283 · 3 trials · 1 indication
An AR is any adverse event (AE) related to the IP injection. Solicited local ARs included pain at injection site, erythema (redness) at injection site, swelling (hardness) at injection site, localized axillary swelling or tenderness ipsilateral to the injection arm, and groin or underarm swelling or tenderness ipsilateral to the side of injection. Solicited systemic ARs included headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, fever, chills, irritability/crying, sleepiness, and loss of appetite. Note, not all solicited ARs were considered AEs. The Investigator determined if solicited AR was also to be recorded as an AE. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. MAAEs were AEs that lead to an unscheduled visit to a healthcare provider. AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
The GMT (50% inhibitory dose \[ID50\]) of nAb against ancestral SARS-CoV-2 and against SARS-CoV-2 variant B.1.351 are reported.
The GMFR measures the changes in immunogenicity titers or levels within participants.
Seroresponse was defined as an increase of SARS-CoV-2 specific binding antibody (bAb) level or nAb titer to at least 4x lower limit of quantification (LLOQ) if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.
The GMT (ID50) of nAb against SARS-CoV-2 omicron variant (B.1.1.529) are reported.
The GMFR measures the changes in immunogenicity titers or levels within participants.
Seroresponse was defined as an increase of SARS-CoV-2 specific bAb level or nAb titer to at least 4x LLOQ if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: mRNA-1283 Dose Level 1 | EXPERIMENTAL | Participants aged 2 to \<12 years receive one IM dose of on Day 1. |
| Cohort 1: mRNA-1283 Dose Level 2 | EXPERIMENTAL | Participants aged 2 to \<12 years receive one IM dose of on Day 1. |
| Cohort 1: mRNA-1273 | ACTIVE_COMPARATOR | Participants aged 2 to \<12 years receive one IM dose of on Day 1. |
| Cohort 2: mRNA-1283 Dose Level 1 | EXPERIMENTAL | Participants aged 6 months to \<2 years receive two IM doses 28 days apart (Days 1 and 29). |
| Cohort 2: mRNA-1283 Dose Level 2 | EXPERIMENTAL | Participants aged 6 months to \<2 years receive two IM doses of 28 days apart (Days 1 and 29). |
| Cohort 2: mRNA-1273 | ACTIVE_COMPARATOR | Participants aged 6 months to \<2 years receive two IM doses 28 days apart (Day 1 and 29). |
| Part A: mRNA-1283 Dose Level 1 | EXPERIMENTAL | Participants will receive single intramuscular (IM) injection of mRNA-1283 at Dose Level 1 on Day 1. |
| Part A: mRNA-1283 Dose Level 2 | EXPERIMENTAL | Participants will receive single IM injection of mRNA-1283 at Dose Level 2 on Day 1. |
| Part A: mRNA-1283 Dose Level 3 | EXPERIMENTAL | Participants will receive single IM injection of mRNA-1283 at Dose Level 3 on Day 1. |
| Part A: mRNA-1283.211 Dose Level 1 | EXPERIMENTAL | Participants will receive single IM injection of mRNA-1283.211 at Dose Level 1 on Day 1. |
| Part A: mRNA-1283.211 Dose Level 2 | EXPERIMENTAL | Participants will receive single IM injection of mRNA-1283.211 at Dose Level 2 on Day 1. |
| Part A: mRNA-1273 | ACTIVE_COMPARATOR | Participants will receive single IM injection of mRNA-1273 on Day 1. |
| Part B: mRNA-1283.529 Dose Level 1 | EXPERIMENTAL | Participants will receive single IM injection of mRNA-1283.529 as a second booster at Dose Level 1 on Day 1. |
| Part B: mRNA-1283.529 Dose Level 2 | EXPERIMENTAL | Participants will receive single IM injection of mRNA-1283.529 as a second booster at Dose Level 2 on Day 1. |
| mRNA-1283 Dose Level 1 | EXPERIMENTAL | Participants will receive 2 intramuscular (IM) injections of mRNA-1283 at Dose Level 1 on Day 1 and Day 29. |
| mRNA-1283 Dose Level 2 | EXPERIMENTAL | Participants will receive 2 IM injections of mRNA-1283 at Dose Level 2 on Day 1 and Day 29. |
| mRNA-1283 Dose Level 3 | EXPERIMENTAL | Participants will receive 2 IM injections of mRNA-1283 at Dose Level 3 on Day 1 and Day 29. |
| mRNA-1273 | EXPERIMENTAL | Participants will receive 2 IM injections of mRNA-1273 at a pre-specified dose for this study on Day 1 and Day 29. |
| Placebo / mRNA-1283 | EXPERIMENTAL | Participants will receive 1 IM injection of study drug-matching placebo on Day 1 and 1 IM injection of mRNA-1283 at a pre-specified dose on Day 29. Participants may be offered an opportunity to receive an additional injection of mRNA-1273 at the pre-specified dose on Open-Label Day 1. |
| Name | Type | Description |
|---|---|---|
| mRNA-1283 | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1273 | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1283.211 | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1283.529 | BIOLOGICAL | Sterile liquid for injection |
| Placebo | BIOLOGICAL | 0.9% sodium chloride (normal saline) injection |
Key Inclusion 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 medi...
mRNA-1283 is an investigational vaccine being developed to prevent SARS-CoV-2, the virus that causes COVID-19. It is being studied both as a primary vaccination series and as a booster dose in healthy volunteers, including adults and, in a newer trial, children from 6 months to under 12 years of age.
mRNA-1283 is being developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. Moderna is the sponsor of the clinical program evaluating the vaccine candidate for SARS-CoV-2 prevention across the trials registered to date.
mRNA-1283 is in Phase 2 clinical development. Two Phase 2 trials and one Phase 1 trial have been registered, with the Phase 1 study and one Phase 2 booster study completed and a Phase 2 pediatric study listed as not yet recruiting. It is investigational and has not been approved by the FDA.
Registered trials include NCT04813796, a completed Phase 1 study of mRNA-1283 and mRNA-1273 in healthy adults aged 18 to 55; NCT05137236, a completed Phase 2 booster study in adults; and NCT07808697, a Phase 2 pediatric study in participants 6 months to under 12 years that is not yet recruiting.
Across the three registered trials, total planned enrollment is 944 participants. The completed Phase 1 study enrolled 104 adults, the completed Phase 2 booster study enrolled 540 adults, and the Phase 2 pediatric study plans to enroll 300 participants. The trials are randomized, double-blind, and controlled.
The completed Phase 1 and Phase 2 booster trials were conducted in the United States. The Phase 2 pediatric study of mRNA-1283 is planned across the United States, Argentina, the Dominican Republic, Mexico, Panama, and Puerto Rico, and it enrolls healthy volunteers aged 6 months to under 12 years.