A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age
NCT ID: NCT04796896
Last Updated: 2025-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
11942 participants
INTERVENTIONAL
2021-03-15
2024-03-15
Brief Summary
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Detailed Description
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Please access http://www.kidcovestudy.com for additional information, such as Study Overview, Participation, Site Locations along with contact numbers for each location for the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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mRNA-1273
Part 1: Participants will receive 2 IM injections of mRNA-1273 at doses pre-specified for this study, on Days 1 and 29. Participants will be offered an optional BD of mRNA-1273 lower than the dose chosen for primary series, ≥6 months after Dose 2. After protocol amendment (PA) 9, participants who have not yet received a BD will be offered a BD with mRNA-1273.214.
Part 2: Participants will receive 2 IM injections of mRNA-1273 at dose selected from Part 1 on Days 1 and 29. Participants (6 to \<12 year) will be offered an optional BD of mRNA-1273 lower than the dose chosen for primary series, ≥6 months after Dose 2. After PA 9, participants who have not yet received a BD will be offered a BD with mRNA-1273.214.
Part 3: Participants will receive 2 IM injections of mRNA-1273 on Days 1 and 29 as primary series then 1 IM injection as Dose 3, on Day 149 ≥3 months and ≤5 months after receipt of Dose 2 of primary series. All 3 injections will be administered at lower dose than that of Part 1.
mRNA-1273
Sterile liquid for injection
mRNA-1273.214
Sterile liquid for injection
Placebo
Part 2 only: Participants will receive 2 IM injections of mRNA-1273-matching placebo on Day 1 and Day 29. Participants (6 to \<12 year old) will be offered an optional BD of mRNA-1273 at a dose lower than the dose that was chosen for the primary series for this age group, at least 6 months post-cross-over Dose 2. After PA 9, participants who have not yet received a BD will be offered a BD with mRNA-1273.214.
mRNA-1273
Sterile liquid for injection
Placebo
0.9% sodium chloride (normal saline) injection
mRNA-1273.214
Sterile liquid for injection
Interventions
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mRNA-1273
Sterile liquid for injection
Placebo
0.9% sodium chloride (normal saline) injection
mRNA-1273.214
Sterile liquid for injection
Eligibility Criteria
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Inclusion Criteria
* Investigator assessment that the parent(s)/legally acceptable representatives understand and are willing and physically able to comply with protocol mandated follow-up, including all procedures, written informed consent is provided, and participants provide assent.
* For children 2 years of age or older has a body mass index at or above the third percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit.
* For children 6 months to \<12 months of age: born at full-term with a minimum birth weight of 2.5 kilograms (kg).
* 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, agreement to continue adequate contraception or abstinence through 3 months following the second injection (Day 29) and the third dose in Part 3 (Day 149/booster dose Day 1), and not currently breastfeeding.
Exclusion Criteria
* Prior administration of an investigational or approved CoV (such as, SARS-CoV-2, SARS CoV, Middle East Respiratory Syndrome CoV) vaccine.
* Treatment with investigational or approved agents for prophylaxis against COVID 19 (such as, receipt of SARS-CoV-2 monoclonal antibodies) within 6 months prior to enrollment.
* Known hypersensitivity to a component of the vaccine or its excipients.
* A medical or psychiatric condition that, according to the investigator's judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results.
* History of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
* Received any non-study vaccine within 14 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine)
* Received intravenous or subcutaneous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to Day 1
* Participated in an interventional clinical study within 28 days prior to Day 0 or plans to donate blood products while participating in this study.
6 Months
11 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Children's of Alabama
Birmingham, Alabama, United States
MedPharmics, LLC
Phoenix, Arizona, United States
Emmaus Research Center Inc
Anaheim, California, United States
Velocity Clinical Research - Banning - ERN- PPDS
Banning, California, United States
SeraCollection Research Services LLC
El Monte, California, United States
UCSD Altman Clinical and Translational Research Institute Building
La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
Rady Childrens Hospital San Diego - PIN
San Diego, California, United States
Carey Chronis MD Pediatric, Infant and Adolescent Medicine - FOMAT
Ventura, California, United States
Children's Hospital Colorado - (CRS)
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Prohealth Research Center
Doral, Florida, United States
University of Florida Jacksonville
Jacksonville, Florida, United States
Kissimmee Clinical Research (KCR)
Kissimmee, Florida, United States
Allied Biomedical Research Institute
Miami, Florida, United States
Pensacola Research Consultants Inc. d/b/a Avanza Medical Research Center
Pensacola, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Iresearch Atlanta, LLC
Decatur, Georgia, United States
iresearch Savannah
Savannah, Georgia, United States
Velocity Clinical Research - Boise - ERN - PPDS
Meridian, Idaho, United States
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
Alliance for Multispecialty Research -El Dorado
El Dorado, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Michael W Simon, MD PSC
Lexington, Kentucky, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
MedPharmics - Platinum
Metairie, Louisiana, United States
Tulane Medical Center
New Orleans, Louisiana, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Javara Inc.
Chevy Chase, Maryland, United States
The Pediatric Centre of Frederick
Frederick, Maryland, United States
Tufts University - Boston - PPDS
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Pediatric Associates of Fall River
Fall River, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Clinical Research Institute, Inc - CRN - PPDS
Minneapolis, Minnesota, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States
MediSync Clinical Research Hattiesburg Clinic
Petal, Mississippi, United States
University of Missouri Health Care System
Columbia, Missouri, United States
Washington University in St. Louis
St Louis, Missouri, United States
Meridian Clinical Research (Hastings, Nebraska)
Hastings, Nebraska, United States
Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS
Norfolk, Nebraska, United States
Quality Clinical Research - PPDS
Omaha, Nebraska, United States
MedPharmics, LLC
Albuquerque, New Mexico, United States
University of New Mexico
Albuquerque, New Mexico, United States
Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
Binghamton, New York, United States
Certified Research Associates
Cortland, New York, United States
Child Healthcare Associates - East Syracuse
East Syracuse, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, United States
Javara Inc. - Winston-Salem
Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio, United States
Lynn Health Science Institute - ERN - PPDS
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Velocity Clinical Research - Providence - ERN - PPDS
Warwick, Rhode Island, United States
Coastal Pediatric Associates
Charleston, South Carolina, United States
Medical University of South Carolina- PPDS
Charleston, South Carolina, United States
Palmetto Pediatrics
North Charleston, South Carolina, United States
Meharry Medical College - Clinical and Translational Research Center & Meharry Medical College - Pediatric Department
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Tekton Research - Texas - Platinum - PPDS
Austin, Texas, United States
BRCR Global Texas
Edinburg, Texas, United States
Pininos Pediatric Services
El Paso, Texas, United States
Ventavia Research Group - Platinum - PPDS
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
West Houston Clinical Research - Hunt
Houston, Texas, United States
Texas Center for Drug Development, Inc
Houston, Texas, United States
Cyfair Clinical Research Center - ERN- PPDS
Houston, Texas, United States
Village Health Partners - HUNT
Plano, Texas, United States
Victoria Clinical Research
Port Lavaca, Texas, United States
Javara, Inc.
The Woodlands, Texas, United States
Crossroads Clinical Research (Victoria)
Victoria, Texas, United States
Tanner Clinic
Layton, Utah, United States
Advanced Clinical Research/Velocity Clinical Research
West Jordan, Utah, United States
PI-Coor Clinical Research, LLC
Burke, Virginia, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
University of Calgary
Calgary, Alberta, Canada
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada
Winnipeg Children's Hospital, HSC-Winnipeg
Winnipeg, Manitoba, Canada
Dalhousie University
Halifax, Nova Scotia, Canada
Childrens Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada
Dr. Anil K. Gupta Medicine Professional Corporation - Clinic/Outpatient Facility
Toronto, Ontario, Canada
McGill University Health Centre-Vaccine Study Centre
Pierrefonds, Quèbec, Canada
Countries
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References
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Rostad CA, Campbell JD, Paulsen GC, Ghamloush SS, Xu W, Zheng L, McElrath MJ, De Rosa SC, Girard B, Das R, Anderson EJ, Creech CB. Evaluation of Cellular Immune Responses After mRNA-1273 Vaccination in Children 6 Months to 11 Years of Age. J Infect Dis. 2025 Jun 2;231(5):e945-e955. doi: 10.1093/infdis/jiaf144.
Berthaud V, Creech CB, Rostad CA, Carr Q, de Leon L, Dietrich M, Gupta A, Javita D, Nachman S, Pinninti S, Rathore M, Rodriguez CA, Luzuriaga K, Towner W, Yeakey A, Brown M, Zhao X, Deng W, Xu W, Zhou H, Girard B, Kelly R, Slobod K, Anderson EJ, Das R, Miller J, Schnyder Ghamloush S. Safety and Immunogenicity of an mRNA-1273 Booster in Children. Clin Infect Dis. 2024 Dec 17;79(6):1524-1532. doi: 10.1093/cid/ciae420.
Anderson EJ, Creech CB, Berthaud V, Piramzadian A, Johnson KA, Zervos M, Garner F, Griffin C, Palanpurwala K, Turner M, Gerber J, Bennett RL, Ali K, Ampajwala M, Berman G, Nayak J, Chronis C, Rizzardi B, Muller WJ, Smith CA, Fuchs G, Hsia D, Tomassini JE, DeLucia D, Reuter C, Kuter B, Zhao X, Deng W, Zhou H, Ramirez Schrempp D, Hautzinger K, Girard B, Slobod K, McPhee R, Pajon R, Aunins A, Das R, Miller JM, Schnyder Ghamloush S; KidCOVE Study Group. Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age. N Engl J Med. 2022 Nov 3;387(18):1673-1687. doi: 10.1056/NEJMoa2209367. Epub 2022 Oct 19.
Creech CB, Anderson E, Berthaud V, Yildirim I, Atz AM, Melendez Baez I, Finkelstein D, Pickrell P, Kirstein J, Yut C, Blair R, Clifford RA, Dunn M, Campbell JD, Montefiori DC, Tomassini JE, Zhao X, Deng W, Zhou H, Ramirez Schrempp D, Hautzinger K, Girard B, Slobod K, McPhee R, Pajon R, Das R, Miller JM, Schnyder Ghamloush S; KidCOVE Study Group. Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age. N Engl J Med. 2022 May 26;386(21):2011-2023. doi: 10.1056/NEJMoa2203315. Epub 2022 May 11.
Lynch LR, Clifford H, Ko R, Hache M, Sun W. Primer of COVID-19 Vaccines for the Perioperative Physician. J Neurosurg Anesthesiol. 2022 Jan 1;34(1):101-106. doi: 10.1097/ANA.0000000000000802.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Click here to access the website, http://www.kidcovestudy.com, for additional information for the study, such as Study Overview, Participation, Site Locations, along with contact numbers for each location for the study.
Other Identifiers
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mRNA-1273-P204
Identifier Type: -
Identifier Source: org_study_id
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