A Study of mRNA-1283.222 Injection Compared With mRNA-1273.222 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (NextCOVE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05815498 |
Recruitment Status :
Active, not recruiting
First Posted : April 18, 2023
Last Update Posted : September 7, 2023
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Biological: mRNA-1283.222 Biological: mRNA-1273.222 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11471 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Randomized, Observer-Blind, Active-Controlled Phase 3 Study to Investigate the Safety, Immunogenicity, and Relative Vaccine Efficacy of mRNA-1283.222 Administered as a Booster Dose Compared With mRNA-1273.222 in Participants Aged 12 Years and Older for the Prevention of COVID-19 |
Actual Study Start Date : | March 28, 2023 |
Estimated Primary Completion Date : | August 23, 2024 |
Estimated Study Completion Date : | August 23, 2024 |
Arm | Intervention/treatment |
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Experimental: mRNA-1283.222
Participants will receive single intramuscular (IM) injection of mRNA-1283.222 on Day 1.
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Biological: mRNA-1283.222
Sterile liquid for injection |
Experimental: mRNA-1273.222
Participants will receive single IM injection of mRNA-1273.222 on Day 1.
|
Biological: mRNA-1273.222
Sterile liquid for injection |
- Geometric Mean Ratio (GMR) of Omicron BA.4/5 mRNA-1283.222 Over the Omicron BA.4/5 mRNA-1273.222 After the Booster Dose [ Time Frame: Day 29 ]
- Seroresponse Rate (SRR) Difference of Omicron BA.4/5 Between mRNA-1283.222 and mRNA-1273.222 After the Booster Dose [ Time Frame: Day 29 ]Seroresponse at the participant level is defined as an antibody value change from baseline below the lower limit of quantification (LLOQ) to ≥4 × LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ and <4 × LLOQ, or at least a 2-fold rise if baseline is ≥4 × LLOQ.
- GMR of the Ancestral SARS-CoV-2 D614G mRNA-1283.222 Over the Ancestral SARS-CoV-2 D614G mRNA-1273.222 After the Booster Dose [ Time Frame: Day 29 ]
- SRR Difference of Ancestral SARS-CoV-2 D641G Between mRNA-1283.222 and mRNA-1273.222 After the Booster Dose [ Time Frame: Day 29 ]Seroresponse at the participant level is defined as an antibody value change from baseline below the (LLOQ) to ≥4 × LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ and <4 × LLOQ, or at least a 2-fold rise if baseline is ≥4 × LLOQ.
- rVE of mRNA-1283.222 and mRNA-1273.222 to Prevent the First Event of COVID-19 [ Time Frame: From 14 days after injection to Day 365 ]The rVE is defined as the percent of reduction in the hazards of the first occurrence of COVID-19 (mRNA-1283.222 vs. mRNA-1273.222) starting 14 days after the booster dose.
- Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [ Time Frame: Up to Day 7 (7-day follow-up after vaccination) ]
- Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 28 (28-day follow-up after vaccination) ]
- Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs) [ Time Frame: Day 1 to end of study (EOS) (Day 365) ]
- Geometric Mean Titers (GMTs) of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G [ Time Frame: Days 91, 181, and 365 ]
- SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G [ Time Frame: Days 29, 91, 181, and 365 ]Seroresponse at the participant level is defined as an antibody value change from baseline below the (LLOQ) to ≥4 × LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ and <4 × LLOQ, or at least a 2-fold rise if baseline is ≥4 × LLOQ.
- Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic) [ Time Frame: From 14 days after injection to Day 365 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.
- 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.
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 degree Celsius [°C]/100.4 degree 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 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05815498
Responsible Party: | ModernaTX, Inc. |
ClinicalTrials.gov Identifier: | NCT05815498 |
Other Study ID Numbers: |
mRNA-1283-P301 |
First Posted: | April 18, 2023 Key Record Dates |
Last Update Posted: | September 7, 2023 |
Last Verified: | September 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
mRNA-1283.222 mRNA-1273.222 SARS-CoV-2 SARS-CoV-2 Vaccine Coronavirus |
Virus Diseases Messenger RNA COVID-19 COVID-19 Vaccine Moderna |
COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |