A Study of mRNA-1283.222 Injection Compared With mRNA-1273.222 Injection in Participants ≥12 Years of Age to Prevent COVID-19

COVID-19 Clinical Trial

— NextCOVE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05815498
• Other study ID #: mRNA-1283-P301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 28, 2023
• Est. completion date: August 23, 2024

Study information

• Verified date: September 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, reactogenicity, and relative vaccine efficacy (rVE) of the mRNA-1283.222 vaccine as well as its immunogenicity in comparison to the mRNA-1273.222 vaccine.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11471
• Est. completion date: August 23, 2024
• Est. primary completion date: August 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• mRNA-1283.222
Sterile liquid for injection
• mRNA-1273.222
Sterile liquid for injection

Locations

Country	Name	City	State
Canada	Intermed groupe santé	Chicoutimi	Quebec
Canada	Hamilton Medical Research group	Hamilton	Ontario
Canada	Milestone Research Inc.	London	Ontario
Canada	Red Maple Trials Inc.	Ottawa	Ontario
Canada	Centricity Research Pointe-Claire	Pointe-Claire	Quebec
Canada	Manna Research Inc.	Pointe-Claire	Quebec
Canada	Clinique spécialisée en allergie	Quebec
Canada	Q&T Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Winterberry Family Medicine	Stoney Creek	Ontario
Canada	Medicor Research Inc.	Sudbury	Ontario
Canada	Centricity Research Toronto Manna Multispecialty	Toronto	Ontario
Canada	Dr. Anil K. Gupta Medicine Professional Corporation	Toronto	Ontario
United Kingdom	Barnsley Hospital	Barnsley
United Kingdom	Royal United Hospital Bath NHS Trust - Royal United Hospital	Bath
United Kingdom	Layton Medical Centre	Blackpool
United Kingdom	Dorset Clinical Research Centre (Bournemouth Hospital)	Bournemouth
United Kingdom	Bradford Teaching Hospitals NHS Foundation Trust - Bradford	Bradford
United Kingdom	Lakeside Healthcare	Corby
United Kingdom	Rotherham Doncaster and South Humber NHS Foundation Trust	Doncaster
United Kingdom	University of Dundee - NHS Tayside - Ninewells Hospital & Me	Dundee
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Royal Devon & Exeter Hospital	Exeter
United Kingdom	CPS Research	Glasgow
United Kingdom	NHS Greater Glasgow & Clyde	Glasgow
United Kingdom	Panthera Biopartners - Glasgow - multispeciality	Glasgow
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Gloucestershire Hospitals NHS Foundation Trust - Cheltenham	Gloucester
United Kingdom	Velocity Clinical Research High Wycombe	High Wycombe
United Kingdom	University Hospitals of Leicester-Leicester Royal Hospital	Leicester
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Egin Research	London
United Kingdom	Guys and St. Thomas NHS Foundation Trust	London
United Kingdom	Hammersmith Medicines Research (HMR)	London
United Kingdom	Panthera Biopartners - Enfield	London
United Kingdom	Richford Gate Medical Practice	London
United Kingdom	Royal Free London NHS Foundation Trust	London
United Kingdom	St Georges Healthcare NHS Trust - University of London	London
United Kingdom	Manchester University NHS Foundation Trust	Manchester
United Kingdom	Bioluminux Clinical Research	Milton Keynes
United Kingdom	Newcastle University - Institute of Cellular Medicine (ICM)	Newcastle
United Kingdom	Velocity Clinical Research	North London
United Kingdom	Accellacare North London	Northwood
United Kingdom	Nottingham University Hospitals NHS Trust - Queens Medical Centre (QMC) Campus	Nottingham
United Kingdom	Stemax Consult Healthcare Services Ltd	Old Stratford
United Kingdom	Wansford and Kings Cliffe Practice	Peterborough
United Kingdom	University Hospitals Plymouth NHS Trust	Plymouth
United Kingdom	Southampton General Hospital - Portsmouth Research Hub	Portsmouth
United Kingdom	GST NHS Found	Preston
United Kingdom	Panthera Biopartners Preston	Preston
United Kingdom	Panthera Biopartners - Manchester - multispeciality	Rochdale
United Kingdom	Warrington and Halton Teaching hospitals NHS Foundation Trust - Halton General Hospital	Runcorn
United Kingdom	Panthera Biopartners - Sheffield - multispeciality	Sheffield
United Kingdom	Royal Victoria Infirmary	Sheffield
United Kingdom	Southampton University Hospital NHS Foundation Trust	Southampton
United Kingdom	Pier Health Group	Weston-super-Mare
United Kingdom	Weymouth Research Hub	Weymouth
United Kingdom	North Wales Clinical Research Centre	Wrexham
United States	IMA Clinical Research	Albuquerque	New Mexico
United States	Velocity Clinical Research- New Mexico	Albuquerque	New Mexico
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Synexus Clinical Research US, Inc	Anderson	South Carolina
United States	Velocity Clinical Research-Anderson	Anderson	South Carolina
United States	Atlanta Clinical Research Center	Atlanta	Georgia
United States	Delricht Research	Atlanta	Georgia
United States	Lynn Institute of Denver	Aurora	Colorado
United States	Benchmark Research	Austin	Texas
United States	Tekton Research Inc	Austin	Texas
United States	Velocity Clinical Research, Banning	Banning	California
United States	Meridian Clinical Research	Baton Rouge	Louisiana
United States	Tekton Research - Beaumont	Beaumont	Texas
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Cope Family Medicine	Bountiful	Utah
United States	DM Clinical Research	Brookline	Massachusetts
United States	Headlands Research Brownsville	Brownsville	Texas
United States	PanAmerican Clinical Research, LLC	Brownsville	Texas
United States	Baybol Research Institute	Chamblee	Georgia
United States	Chandler Clinical Trials	Chandler	Arizona
United States	Delricht Research	Charleston	South Carolina
United States	Chicago Clinical Research Institute	Chicago	Illinois
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	Velocity Clinical Research- Chula Vista	Chula Vista	California
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Velocity Clinical Research	Cincinnati	Ohio
United States	Velocity Clinical Research - Cincinnati	Cincinnati	Ohio
United States	Velocity Clinical Research, Inc	Cincinnati	Ohio
United States	Velocity Clinical Research	Cleveland	Ohio
United States	Benchmark Research	Colton	California
United States	Velocity Clinical Research	Columbia	South Carolina
United States	Centricity Research	Columbus	Georgia
United States	Alliance for Multispeciality Research - Miami	Coral Gables	Florida
United States	Benchmark Research	Covington	Louisiana
United States	MedPharmics	Covington	Louisiana
United States	Nature Coast Clinical Research	Crystal River	Florida
United States	Beautiful Minds Clinical Research Center	Cutler Bay	Florida
United States	Zenos Clinical Research	Dallas	Texas
United States	Elite Research Network	Decatur	Georgia
United States	Clinical Research Partners LLC	DeLand	Florida
United States	Hillcrest Medical Research, LLC	DeLand	Florida
United States	Velocity Clinical Research Denver	Denver	Colorado
United States	Velocity Clinical Research, Syracuse	East Syracuse	New York
United States	Accel Research Sites Lake Oconee	Eatonton	Georgia
United States	Tekton Research- Edmond	Edmond	Oklahoma
United States	Alliance for Multispecialty Research, LLC	El Dorado	Kansas
United States	Centennial Medical Group	Eldridge	Maryland
United States	Tekton Research - Fort Collins	Fort Collins	Colorado
United States	Benchmark Research	Fort Worth	Texas
United States	Ventavia Research Group	Fort Worth	Texas
United States	CCT research/ Methodist Physicians Clinic- Prairie Fields	Fremont	Nebraska
United States	Velocity Clinical Research	Grand Island	Nebraska
United States	Velocity Clinical Research, Greenville	Greenville	South Carolina
United States	Delricht Research	Gulfport	Mississippi
United States	Velocity Clinical Research, Hallandale Beach	Hallandale Beach	Florida
United States	Delricht Research	Hendersonville	Tennessee
United States	Sweet Hope Research Specialty, Inc.	Hialeah	Florida
United States	CenExel Research Centers of America	Hollywood	Florida
United States	DM Clinical Research	Houston	Texas
United States	DM Clinical Research	Houston	Texas
United States	Marvel Clinical Research 002, LLC	Huntington Beach	California
United States	Velocity Clinical Research Huntington Park	Huntington Park	California
United States	Optimal Research	Huntsville	Alabama
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Clinical Neuroscience Solutions, Inc	Jacksonville	Florida
United States	Encore Research Group-Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Health Awareness INC	Jupiter	Florida
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	Ventavia Research Group	Keller	Texas
United States	Velocity Clinical Research	La Mesa	California
United States	Accel Clinical Research	Lakeland	Florida
United States	Chemidox Clinical Trials	Lancaster	California
United States	Accel Research Sites	Largo	Florida
United States	Wr-Crcn, Llc	Las Vegas	Nevada
United States	Johnson County Clin-Trials, Inc (JCCT)	Lenexa	Kansas
United States	Alliance for Multispecialty Research-Lexington	Lexington	Kentucky
United States	Meridian Clinical Research, LLC	Lincoln	Nebraska
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	Long Beach Clinical Trials	Long Beach	California
United States	Tekton Research, Inc- Longmont Center	Longmont	Colorado
United States	Velocity Clinical Research- Westlake	Los Angeles	California
United States	Acclaim Clinical Research	Maitland	Florida
United States	DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE	McKinney	Texas
United States	Velocity Clinical Research, Medford	Medford	Oregon
United States	Velocity Clinical Research	Meridian	Idaho
United States	Benchmark Research	Metairie	Louisiana
United States	Clinical Trials of Florida	Miami	Florida
United States	Suncoast Research Associates, LLC	Miami	Florida
United States	Suncoast Research Group, LLC	Miami	Florida
United States	Floridian Clinical Research	Miami Lakes	Florida
United States	Global Health Research Center, Inc.	Miami Lakes	Florida
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Montana Medical Research, Inc	Missoula	Montana
United States	Monroe Biomedical Research	Monroe	North Carolina
United States	Tekton Research Inc	Moore	Oklahoma
United States	Carolina Health Specialists	Myrtle Beach	South Carolina
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Delricht Research	New Orleans	Louisiana
United States	IMA Clinical Research	New York	New York
United States	Health Research of Hampton Roads, Inc.	Newport News	Virginia
United States	Georgia Clinic, PC/CCT Research	Norcross	Georgia
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Velocity Clinical Research-North Hollywood	North Hollywood	California
United States	Las Vegas Clinical Trials	North Las Vegas	Nevada
United States	Velocity Clinical Research	Omaha	Nebraska
United States	Clinical Neuroscience Solutions (CNS Healthcare site)	Orlando	Florida
United States	Headlands Research Orlando	Orlando	Florida
United States	Innovation Medical Research Center	Palmetto Bay	Florida
United States	Papillon Research Centre	Papillion	Nebraska
United States	Pines Care Research Center, Inc.	Pembroke Pines	Florida
United States	Suncoast Research Associates, LLC	Pembroke Pines	Florida
United States	DM Clinical Research	Philadelphia	Pennsylvania
United States	FRC - CCT Research	Phoenix	Arizona
United States	Phoenix Clinical Research LLC	Phoenix	Arizona
United States	Synexus	Pinellas Park	Florida
United States	Research Your Health	Plano	Texas
United States	Mountain View Ogden Clinic/CCT Research	Pleasant View	Utah
United States	Empire Clinical Research	Pomona	California
United States	Summit Research Headlands LLC	Portland	Oregon
United States	Velocity Clinical Research	Portsmouth	Virginia
United States	Delricht Clinical Research	Prairieville	Louisiana
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	Artemis Institute for Clinical Research	Riverside	California
United States	CenExel - CITrials	Riverside	California
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Peninsula Research Associates	Rolling Hills Estates	California
United States	Be Well Clinical Studies	Round Rock	Texas
United States	Benchmark Research	Sacramento	California
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah
United States	JBR Clinical Research	Salt Lake City	Utah
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Diagnostics Research Group	San Antonio	Texas
United States	Tekton Research -San Antonio	San Antonio	Texas
United States	Acclaim Clinical Research	San Diego	California
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Headlands Research Sarasota	Scottsdale	Arizona
United States	Great Lakes Research Institute	Southfield	Michigan
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Velocity Clinical Research- Spartanburg	Spartanburg	South Carolina
United States	Delricht Research	Springfield	Missouri
United States	Clinical Research Atlanta/Headlands	Stockbridge	Georgia
United States	DM Clinical Research	Sugar Land	Texas
United States	Precision Clinical Research	Sunrise	Florida
United States	Global Health Research Center, Inc.	Tampa	Florida
United States	Santos Research Center CORP	Tampa	Florida
United States	Clinical Research Consortium	Tempe	Arizona
United States	DM Clinical Research	Tomball	Texas
United States	Delricht Research	Town And Country	Missouri
United States	Del Sol research Management LLC.	Tucson	Arizona
United States	Noble Clinical Research, LLC	Tucson	Arizona
United States	Delricht Research	Tulsa	Oklahoma
United States	Velocity Clinical Research Valparaiso	Valparaiso	Indiana
United States	Versailles Family Medicine	Versailles	Kentucky
United States	Accel Research Sites- Achieve Clinical Research	Vestavia Hills	Alabama
United States	IMA Clinical Research	Warren	New Jersey
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Alliance for Multispecialty Research, LLC- Wichita	Wichita	Kansas
United States	Tekton Research Inc	Wichita	Kansas
United States	Trial Management Associates, LLC	Wilmington	North Carolina
United States	Tekton Research- Yukon	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Day 29
Primary	Seroresponse Rate (SRR) Difference of Omicron BA.4/5 Between mRNA-1283.222 and mRNA-1273.222 After the Booster Dose	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.	Day 29
Primary	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		Day 29
Primary	SRR Difference of Ancestral SARS-CoV-2 D641G Between mRNA-1283.222 and mRNA-1273.222 After the Booster Dose	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.	Day 29
Primary	rVE of mRNA-1283.222 and mRNA-1273.222 to Prevent the First Event of COVID-19	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.	From 14 days after injection to Day 365
Primary	Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)		Up to Day 7 (7-day follow-up after vaccination)
Primary	Number of Participants with Unsolicited Adverse Events (AEs)		Up to Day 28 (28-day follow-up after vaccination)
Primary	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 to end of study (EOS) (Day 365)
Secondary	Geometric Mean Titers (GMTs) of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G		Days 91, 181, and 365
Secondary	SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G	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.	Days 29, 91, 181, and 365
Secondary	Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)		From 14 days after injection to Day 365