> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-mrna-1283-injection-compared-with-mrna-1273-fc016ec0-43c6-4fa9-b41a-ce927329718d > Record changed: 2026-10-13 # A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19 NCT05815498 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) Participants 13,553 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) Lead sponsor ModernaTX, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) Start date 2023-03-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) Number of sites 230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) ## Title and summary **Summary** The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815 (Part 2). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Acronym** NextCOVE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Short title** A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Official title** A Randomized, Observer-Blind, Active-Controlled Phase 3 Study to Investigate the Safety, Immunogenicity, and Relative Vaccine Efficacy of mRNA-1283 Compared With mRNA-1273 in Participants Aged ≥12 Years for the Prevention of COVID-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) ## Status and phase **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) ## Dates **Completion date** 2025-04-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **First posted** 2023-04-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Registry last updated** 2026-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Primary completion date** 2025-04-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Start date** 2023-03-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) ## Size and sites **Actual participants** 13,553 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Participants** 13,553 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Number of sites** 230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Lead sponsor** ModernaTX, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) ## Identifiers **Registry ID** NCT05815498 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **ClinicalTrials.gov ID** NCT05815498 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) ## Outcomes ### Primary outcomes 1. Part 1: Geometric Mean (GM) of Omicron BA.4/5 at Day 29 Timeframe: 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. 2. Part 1: Seroresponse Rate (SRR) Omicron BA.4/5 at Day 29 Timeframe: 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. 3. Part 1: GM of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G at Day 29 Timeframe: 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. 4. Part 1: SRR of Ancestral SARS-CoV-2 D641G at Day 29 Timeframe: 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. 5. Part 1: Number of Participants With First Event of Centers for Disease Control and Prevention (CDC)-Defined COVID-19 Timeframe: 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. 6. Part 1: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Timeframe: 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. 7. Part 3: Number of Participants With Solicited Local and Systemic ARs Timeframe: 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. 8. Part 1: Number of Participants With Unsolicited Adverse Events (AEs) Timeframe: 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. 9. Part 3: Number of Participants With Unsolicited AEs Timeframe: 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. 10. 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) Timeframe: 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. 11. Part 3: Number of Participants With Any SAEs, MAAEs, AEs Leading to Withdrawal From Study, and AESIs Timeframe: 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 outcomes 1. Part 1: GMs of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G Timeframe: Days 91, 181, and 365 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 103 AU/mL and ULOQ was 28571 AU/mL for Omicron BA.4/5\. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL for ancestral SARS-CoV-2 D614G. 2. Part 1: SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G at Days 91, 181, and 365 Timeframe: Days 91, 181, and 365 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 for Omicron BA.4/5\. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL for ancestral SARS-CoV-2 D614G. 3. Part 1: Number of Participants With a SARS-CoV-2 Infection (Symptomatic or Asymptomatic) Timeframe: From 14 days after injection up to Day 365 SARS-CoV-2 infection (symptomatic or asymptomatic) was defined as (1) negative binding antibody (bAb) level against SARS-CoV-2 nucleocapsid protein and negative RT-PCR at baseline that became positive bAb level against SARS-CoV-2 nucleocapsid protein post-baseline, or (2) positive RT-PCR post-baseline. Asymptomatic SARS-CoV-2 infection was characterized by the absence of COVID-19 symptoms. 4. Part 3: GM of Omicron XBB.1.5 in Unvaccinated Participants Timeframe: 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 38 AU/mL and ULOQ was 6960 AU/mL. 5. Part 3: GM of Omicron XBB.1.5 in All Study Participants Timeframe: 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 38 AU/mL and ULOQ was 6960 AU/mL. 6. Part 3: SRR Against Omicron XBB.1.5 in Unvaccinated Participants Timeframe: 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 last non-missing measurement on or before study vaccination day. LLOQ was 38 AU/mL and ULOQ was 6960 AU/mL. 7. Part 3: SRR Against Omicron XBB.1.5 in All Study Participants Timeframe: 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 last non-missing measurement on or before study vaccination day. LLOQ was 38 AU/mL and ULOQ was 6960 AU/mL. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) ## Eligibility **Sex** All **Age groups** Children, Adults, Older adults **Minimum age** 12 Years **Healthy volunteers** Yes 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 abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, and agreement to continue adequate contraception or abstinence through 90 days following the vaccine administration. - Part 1: Has previously received a primary series of an authorized/approved COVID-19 vaccine. For participants ≥18 years of age, at least 1 booster dose must have also been received. Proof of prior vaccination is required. A heterologous vaccine regimen is acceptable. Part 2: No prior vaccination is required. For participants who have been previously vaccinated, proof of vaccination is required. Key Exclusion Criteria: - Has had close contact, as defined by the Centers for Disease Control and Prevention (CDC), with someone who had a SARS-CoV-2 infection in the past 14 days, or COVID-19 in the past 10 days. - Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1. - Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. - Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 181 days prior to Screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. - Has received or plans to receive any licensed vaccine ≤60 days prior to the study injection (Day 1) or plans to receive a licensed vaccine within 60 days after the study injection. - Has received systemic immunoglobulins or blood products within 90 days prior to the Screening Visit or plans to receive during the study. - Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study. - Has participated in an interventional 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. Note: Other inclusion and exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) ## Sites - Optimal ResearchHuntsville, United States - Accel Research Sites- Achieve Clinical ResearchVestavia Hills, United States - Chandler Clinical TrialsChandler, United States - Phoenix Clinical Research LLCPhoenix, United States - FRC - CCT ResearchPhoenix, United States - Headlands Research SarasotaScottsdale, United States - Clinical Research ConsortiumTempe, United States - Noble Clinical Research, LLCTucson, United States - Del Sol research Management LLC.Tucson, United States - Lynn Institute of the OzarksLittle Rock, United States - Anaheim Clinical Trials, LLCAnaheim, United States - Velocity Clinical Research, BanningBanning, United States - Velocity Clinical Research- Chula VistaChula Vista, United States - Benchmark ResearchColton, United States - Marvel Clinical Research 002, LLCHuntington Beach, United States - Velocity Clinical Research Huntington ParkHuntington Park, United States - Velocity Clinical ResearchLa Mesa, United States - Chemidox Clinical TrialsLancaster, United States - Long Beach Clinical TrialsLong Beach, United States - Velocity Clinical Research- WestlakeLos Angeles, United States - Velocity Clinical Research-North HollywoodNorth Hollywood, United States - Empire Clinical ResearchPomona, United States - CenExel - CITrialsRiverside, United States - Artemis Institute for Clinical ResearchRiverside, United States - Peninsula Research AssociatesRolling Hills Estates, United States And 205 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) ## References - PubMed 40639387 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40639387/) Related publication ### Other registry identifiers (2) - 2023 - 2023-000884-30 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815498) ## Related records ### Drugs (1) - [Elasomeran](https://trialight.com/data/asset/elasomeran-7d917cbd-1f45-43e8-a188-fd6dec78e983.md) ### Lead sponsors (1) - [ModernaTX, Inc.](https://trialight.com/data/company/modernatx-inc-8ece6782-e44c-4999-be6a-0b94e61dfff5.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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