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mRNA-1283.222

Phase 3

COVID-19 | Monoclonal antibody | Infectious Disease |Moderna, Inc.|Last Updated: May 1, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment13,553
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05815498A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19PHASE3 COMPLETED 13,553Mar 28, 2023Apr 12, 2025May 1, 2026230 United States, Canada +2
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Study Endpoints
Primary Endpoints
Part 1: Geometric Mean (GM) of Omicron BA.4/5 at Day 29
Day 29

Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available. LLOQ was 103 arbitrary units (AU)/milliliter (mL) and ULOQ was 28571 AU/mL.

Part 1: Seroresponse Rate (SRR) Omicron BA.4/5 at Day 29
Day 29

Seroresponse was defined as an antibody value change from baseline below the LLOQ to ≥4\*LLOQ, or at least a 4-fold rise if baseline was ≥LLOQ and \<4\*LLOQ, or at least a 2-fold rise if baseline was ≥4\*LLOQ, where baseline referred to pre-booster. LLOQ was 103 AU/mL and ULOQ was 28571 AU/mL.

Part 1: GM of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G at Day 29
Day 29

Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL.

Part 1: SRR of Ancestral SARS-CoV-2 D641G at Day 29
Day 29

Seroresponse was defined as an antibody value change from baseline below the LLOQ to ≥4\*LLOQ, or at least a 4-fold rise if baseline was ≥LLOQ and \<4\*LLOQ, or at least a 2-fold rise if baseline was ≥4\*LLOQ, where baseline referred to pre-booster. LLOQ was 10 AU/mL and ULOQ was 111433AU/mL.

Part 1: Number of Participants With First Event of Centers for Disease Control and Prevention (CDC)-Defined COVID-19
From 14 days after injection up to Day 365

CDC COVID-19 definition: the presence of at least 1 CDC listed symptom and positive reverse transcriptase polymerase chain reaction (RT-PCR) test on a respiratory sample.

Part 1: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Up to Day 7 (7-day follow-up after vaccination)

Solicited ARs were recorded daily using electronic diaries (eDiaries). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

Part 3: Number of Participants With Solicited Local and Systemic ARs
Up to Day 7 (7-day follow-up after vaccination)

Solicited ARs were recorded daily using eDiaries. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

Part 1: Number of Participants With Unsolicited Adverse Events (AEs)
Up to Day 28 (28-day follow-up after vaccination)

An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Part 3: Number of Participants With Unsolicited AEs
Up to Day 28 (28-day follow-up after vaccination)

An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Part 1: Number of Participants With Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs)
Day 1 up to Day 365

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. AEs leading to the withdrawal from study reported for this endpoint also include the AEs that led to death. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Part 3: Number of Participants With Any SAEs, MAAEs, AEs Leading to Withdrawal From Study, and AESIs
Day 1 up to Day 181

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. AEs leading to the withdrawal from study reported for this endpoint also include the AEs that led to death. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Secondary Endpoints
Part 1: GMs of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G
Days 91, 181, and 365
Part 1: SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G at Days 91, 181, and 365
Days 91, 181, and 365
Part 1: Number of Participants With a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)
From 14 days after injection up to Day 365
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Part 1: mRNA-1283.222EXPERIMENTALParticipants will receive single intramuscular (IM) injection of mRNA-1283.222 on Day 1.
Part 1: mRNA-1273.222EXPERIMENTALParticipants will receive single IM injection of mRNA-1273.222 on Day 1.
Part 2: mRNA-1283.815EXPERIMENTALParticipants will receive single IM injection of mRNA-1283.815 on Day 1.
Part 2: mRNA-1273.815EXPERIMENTALParticipants will receive single IM injection of mRNA-1273.815 on Day 1.
Interventions
NameTypeDescription
mRNA-1283.222BIOLOGICALSterile liquid for injection
mRNA-1273.222BIOLOGICALSterile liquid for injection
mRNA-1283.815BIOLOGICALSterile liquid for injection
mRNA-1273.815BIOLOGICALSterile liquid for injection
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites230

Key Inclusion Criteria: * Investigator's assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures. * For female participants of childbearing potential: negative pregnancy test, adequate contraception or has a...

Countries:United StatesCanadaJapanUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMJun 1, 2026NCT05815498TRIAL_REMOVED: changed
MEDIUMJun 1, 2026NCT05815498TRIAL_REMOVED: changed
MEDIUMJun 1, 2026NCT05815498TRIAL_REMOVED: changed