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

A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age

The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injection in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an optional booster dose (BD) (in Parts 1 and 2).

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2
• Intervention / Treatment: Biological: Placebo; Biological: mRNA-1273.214; Biological: mRNA-1273

Detailed Description

This is a Phase 2/3, 3-part, open-label, dose-escalation, age de-escalation, randomized, observer-blind, placebo-controlled, expansion study intended to infer the effectiveness of mRNA-1273 in children aged 6 months to less than 12 years.

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.

• Study Type: Interventional
• Enrollment (Actual): 11950
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • University of Calgary
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4H4
      • Children's and Women's Health Centre of British Columbia
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Winnipeg Children's Hospital, HSC-Winnipeg
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1
      • Dalhousie University
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L1
      • Childrens Hospital of Eastern Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children (SickKids)
    • Toronto, Ontario, Canada, M9V 4B4
      • Dr. Anil K. Gupta Medicine Professional Corporation - Clinic/Outpatient Facility
  • Quebec
    • Pierrefonds, Quebec, Canada, H9H 4Y6
      • McGill University Health Centre-Vaccine Study Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-1711
      • Children's of Alabama
  • Arizona
    • Phoenix, Arizona, United States, 85015-1105
      • MedPharmics, LLC
  • California
    • Anaheim, California, United States, 92804-1866
      • Emmaus Research Center Inc
    • Banning, California, United States, 92220-3082
      • Velocity Clinical Research - Banning - ERN- PPDS
    • El Monte, California, United States, 91731
      • SeraCollection Research Services LLC
    • La Jolla, California, United States, 92037
      • UCSD Altman Clinical and Translational Research Institute Building
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Paramount, California, United States, 90723-5459
      • Center for Clinical Trials, LLC
    • San Diego, California, United States, 92123
      • Rady Childrens Hospital San Diego - PIN
    • Ventura, California, United States, 93003-5369
      • Carey Chronis MD Pediatric, Infant and Adolescent Medicine - FOMAT
  • Colorado
    • Aurora, Colorado, United States, 80045-7144
      • Children's Hospital Colorado - (CRS)
  • Connecticut
    • New Haven, Connecticut, United States, 06519-1712
      • Yale University School Of Medicine
  • Florida
    • Doral, Florida, United States, 33166
      • Prohealth Research Center
    • Jacksonville, Florida, United States, 32209-6511
      • University of Florida Jacksonville
    • Kissimmee, Florida, United States, 34743
      • Kissimmee Clinical Research (KCR)
    • Miami, Florida, United States, 33155-4630
      • Allied Biomedical Research Institute
    • Pensacola, Florida, United States, 32503
      • Pensacola Research Consultants Inc. d/b/a Avanza Medical Research Center
    • Tampa, Florida, United States, 33613-3946
      • University of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322-1014
      • Emory University School Of Medicine
    • Decatur, Georgia, United States, 30030-3438
      • iResearch Atlanta, LLC
    • Savannah, Georgia, United States, 31405
      • iResearch Savannah
  • Idaho
    • Meridian, Idaho, United States, 83642-6246
      • Velocity Clinical Research - Boise - ERN - PPDS
  • Illinois
    • Chicago, Illinois, United States, 60611-2991
      • Ann and Robert H Lurie Childrens Hospital of Chicago
  • Kansas
    • El Dorado, Kansas, United States, 67042-2187
      • Alliance for Multispecialty Research -El Dorado
  • Kentucky
    • Lexington, Kentucky, United States, 40504-3516
      • University of Kentucky
    • Lexington, Kentucky, United States, 40517-8366
      • Michael W Simon, MD PSC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Pennington Biomedical Research Center
    • Baton Rouge, Louisiana, United States, 70809
      • Our Lady of the Lake Regional Medical Center
    • Metairie, Louisiana, United States, 70006-4152
      • MedPharmics - Platinum
    • New Orleans, Louisiana, United States, 70112
      • Tulane Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201-1519
      • University of Maryland School of Medicine
    • Chevy Chase, Maryland, United States, 20815
      • Javara Inc.
    • Frederick, Maryland, United States, 21702-4747
      • The Pediatric Centre of Frederick
  • Massachusetts
    • Boston, Massachusetts, United States, 02114-2621
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111-1552
      • Tufts University - Boston - PPDS
    • Fall River, Massachusetts, United States, 02721-1778
      • Pediatric Associates of Fall River
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202-2608
      • Henry Ford Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota Masonic Children's Hospital
    • Minneapolis, Minnesota, United States, 55402-2700
      • Clinical Research Institute, Inc - CRN - PPDS
  • Mississippi
    • Petal, Mississippi, United States, 39465
      • MediSync Clinical Research Hattiesburg Clinic
  • Missouri
    • Columbia, Missouri, United States, 65212-1000
      • University of Missouri Health Care System
    • Saint Louis, Missouri, United States, 63110-1010
      • Washington University in St. Louis
  • Nebraska
    • Hastings, Nebraska, United States, 68901
      • Meridian Clinical Research (Hastings, Nebraska)
    • Norfolk, Nebraska, United States, 68701-2669
      • Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS
    • Omaha, Nebraska, United States, 68114-3723
      • Quality Clinical Research - PPDS
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • MedPharmics, LLC
    • Albuquerque, New Mexico, United States, 87106-2719
      • University of New Mexico
  • New York
    • Binghamton, New York, United States, 13901-1046
      • Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
    • Cortland, New York, United States, 13045-9398
      • Certified Research Associates
    • East Syracuse, New York, United States, 13057
      • Child Healthcare Associates - East Syracuse
    • Rochester, New York, United States, 14642-0001
      • University of Rochester Medical Center
    • Stony Brook, New York, United States, 11794-0001
      • Stony Brook University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28208
      • OnSite Clinical Solutions, LLC
    • Winston-Salem, North Carolina, United States, 27101-4263
      • Javara Inc. - Winston-Salem
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3026
      • Cincinnati Children's Hospital Medical Center - PIN
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112-4703
      • Lynn Health Science Institute - ERN - PPDS
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4319
      • Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15213-1481
      • Children's Hospital of Pittsburgh
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886-1617
      • Velocity Clinical Research - Providence - ERN - PPDS
  • South Carolina
    • Charleston, South Carolina, United States, 29414-5834
      • Coastal Pediatric Associates
    • Charleston, South Carolina, United States, 29425-8903
      • Medical University of South Carolina- PPDS
    • North Charleston, South Carolina, United States, 29406-9170
      • Palmetto Pediatrics
  • Tennessee
    • Nashville, Tennessee, United States, 37232-0011
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37208-3501
      • Meharry Medical College - Clinical and Translational Research Center & Meharry Medical College - Pediatric Department
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research - Texas - Platinum - PPDS
    • Edinburg, Texas, United States, 78539-8462
      • BRCR Global Texas
    • El Paso, Texas, United States, 79902-1139
      • Pininos Pediatric Services
    • Houston, Texas, United States, 77081
      • Texas Center for Drug Development, Inc
    • Houston, Texas, United States, 77030-3411
      • Baylor College of Medicine
    • Houston, Texas, United States, 77008-1398
      • Ventavia Research Group - Platinum - PPDS
    • Houston, Texas, United States, 77055-1626
      • West Houston Clinical Research - Hunt
    • Houston, Texas, United States, 77375-6579
      • Cyfair Clinical Research Center - ERN- PPDS
    • Plano, Texas, United States, 75024
      • Village Health Partners - HUNT
    • Port Lavaca, Texas, United States, 77901-5531
      • Victoria Clinical Research
    • The Woodlands, Texas, United States, 77382
      • Javara, Inc.
    • Victoria, Texas, United States, 77901
      • Crossroads Clinical Research (Victoria)
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Clinic
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research/Velocity Clinical Research
  • Virginia
    • Burke, Virginia, United States, 22015-1635
      • PI-Coor Clinical Research, LLC
    • Richmond, Virginia, United States, 23226
      • Clinical Research Partners, LLC
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-0001
      • University of Wisconsin - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• For participants with chronic diseases (such as, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus [HIV] infection), the disease should be stable, per investigator assessment.
• 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.

Key Exclusion Criteria:

• Known history of SARS-CoV-2 infection within 2 weeks prior to administration of vaccine or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to administration of vaccine.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: mRNA-1273.214; Sterile liquid for injection; Biological: mRNA-1273; Sterile liquid for injection
Placebo Comparator: 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.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: mRNA-1273.214; Sterile liquid for injection; Biological: mRNA-1273; Sterile liquid for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)		Up to Day 156 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)		Up to Day 177 (28 days after each injection)
Number of Participants with Medically-Attended AEs (MAAEs)		Up to Day 514 (1 year after booster dose)
Number of Participants with Serious Adverse Events (SAEs)		Up to Day 514 (1 year after booster dose)
Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C), Myocarditis and/or Pericarditis		Up to Day 514 (1 year after booster dose)
Number of Participants with AEs Leading to Discontinuation From Study Post-Booster Dose Through the Last Day of Study Participation		Day 149 (booster dose Day 1) through the last day of study participation (Day 514)
Number of Participants with Serum Antibody Levels that Meet or Exceed the Threshold of Protection From COVID-19	Threshold of protection as predefined for study.	Day 57 (1 month after second injection)
Geometric Mean (GM) Value of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Serum Antibody		Day 57 (1 month after second injection)
Seroresponse Rate of Vaccine Recipients		Day 57 (1 month after second injection)
GM Value of Post-Booster Dose SARS-CoV-2 Specific Serum Antibody		Day 149 (post third dose)
Seroresponse Rate of Post-Booster Dose of Vaccine Recipients		Day 149 (post third dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GM Value of SARS-CoV-2 S-Protein-Specific Binding Antibody (bAb)		Day 1, Day 57, Day 209, Day 394, booster dose Day 1, booster dose Day 29, booster dose Day 181, and booster dose Day 366
GM Value of SARS-CoV-2- Specific Neutralizing Antibody (nAb)		Day 1, Day 57, Day 209, Day 394, booster dose Day 1, booster dose Day 29, booster dose Day 181, and booster dose Day 366
Number of Participants with SARS-CoV-2 Infections Regardless of Symptomatology, as Assessed by Serology and/or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)	Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.	Up to Day 394
Number of Participants with SARS-CoV-2 Infection Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein in Participants with Negative SARS-CoV-2 at Baseline, in the Absence of Any COVID-19 Symptoms		Up to Day 394
Number of Participants with a First Occurrence of COVID-19	Clinical signs indicative of COVID-19 as predefined for the study.	Up to Day 394

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Coronavirus; COVID-19; SARS-CoV-2 Vaccine; Virus Diseases; Moderna; Messenger RNA; COVID-19 Vaccine; mRNA-1273 vaccine; mRNA-1273
• Other Study ID Numbers: mRNA-1273-P204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No