ClinicalTrials.gov

History of Changes for Study: NCT04796896
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
Latest version (submitted December 1, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 11, 2021 None (earliest Version on record)
2 March 17, 2021 Recruitment Status, Study Status, References, Contacts/Locations, Study Design and Study Description
3 March 26, 2021 Contacts/Locations and Study Status
4 April 5, 2021 Study Status and Contacts/Locations
5 April 12, 2021 Contacts/Locations and Study Status
6 April 25, 2021 Contacts/Locations and Study Status
7 May 19, 2021 Outcome Measures, Study Status, Contacts/Locations, Eligibility, Arms and Interventions and Study Design
8 June 22, 2021 Contacts/Locations, Study Status and Study Identification
9 July 13, 2021 Study Status, Contacts/Locations and Study Design
10 August 3, 2021 Outcome Measures, Study Design and Study Status
11 August 20, 2021 Study Status and Contacts/Locations
12 September 20, 2021 Contacts/Locations and Study Status
13 October 12, 2021 Study Status
14 November 1, 2021 Contacts/Locations and Study Status
15 November 11, 2021 Contacts/Locations and Study Status
16 November 15, 2021 Contacts/Locations and Study Status
17 December 1, 2021 Study Status and Contacts/Locations
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Changes (Merged) for Study: NCT04796896
July 13, 2021 (v9) -- August 3, 2021 (v10)

Changes in: Study Status, Study Design and Outcome Measures

Open or close this module Study Identification
Unique Protocol ID: mRNA-1273-P204
Brief Title: 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
Official Title: A Phase 2/3, Two-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
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2021
Overall Status: Recruiting
Study Start: March 15, 2021
Primary Completion: June 12, 2023 [Anticipated]
Study Completion: June 12, 2023 [Anticipated]
First Submitted: March 11, 2021
First Submitted that
Met QC Criteria:
March 11, 2021
First Posted: March 15, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
July 13, 2021 August 3, 2021
Last Update Posted: July 15 August 10, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: ModernaTX, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children in 2 doses, 28 days apart.
Detailed Description:

This is a Phase 2/3, 2-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.

Open or close this module Conditions
Conditions: SARS-CoV-2
Keywords: mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 6975 13275 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: mRNA-1273

Part 1: Participants will receive 2 intramuscular (IM) injections of mRNA-1273 at up to 3 doses pre-specified for this study, 28 days apart, on Day 1 and Day 29.

Part 2: Participants will receive 2 IM injections of mRNA-1273 at the dose selected from Part 1, 28 days apart, on Day 1 and Day 29.

Biological: mRNA-1273
Sterile liquid for injection
Placebo Comparator: Placebo
Part 2 only: Participants will receive 2 IM injections of mRNA-1273-matching placebo 28 days apart, on Day 1 and Day 29.
Biological: Placebo
0.9% sodium chloride (normal saline) injection
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
[ Time Frame: Up to Day 36 (7 days after each injection) ]

2. Number of Participants with Unsolicited Adverse Events (AEs)
[ Time Frame: Up to Day 57 (28 days after each injection) ]

3. Number of Participants with Medically-Attended AEs (MAAEs)
[ Time Frame: Up to Day 394 (1 year after second injection) ]

4. Number of Participants with Serious Adverse Events (SAEs)
[ Time Frame: Up to Day 394 (1 year after second injection) ]

5. Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C), Myocarditis and/or Pericarditis
[ Time Frame: Up to Day 394 (1 year after second injection) ]

6. Number of Participants with Serum Antibody Levels that Meet or Exceed the Threshold of Protection From COVID-19
[ Time Frame: Day 57 (1 month after second injection) ]

Threshold of protection as predefined for study.
7. Geometric Mean (GM) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Serum Antibody
[ Time Frame: Day 57 (1 month after second injection) ]

8. Seroresponse Rate of Vaccine Recipients
[ Time Frame: Day 57 (1 month after second injection) ]

Secondary Outcome Measures:
1. GM of SARS-CoV-2 S-Protein-Specific Binding Antibody (bAb)
[ Time Frame: Day 1, Day 57, Day 209, and Day 394 ]

2. GM of SARS-CoV-2- Specific Neutralizing Antibody (nAb)
[ Time Frame: Day 1, Day 57, Day 209, and Day 394 ]

3. Number of Participants with SARS-CoV-2 Infections Regardless of Symptomatology, as Assessed by Serology and/or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
[ Time Frame: Up to Day 394 ]

Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.
4. 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
[ Time Frame: Up to Day 394 ]

5. Number of Participants with a First Occurrence of COVID-19
[ Time Frame: Up to Day 394 ]

Clinical signs indicative of COVID-19 as predefined for the study.
Open or close this module Eligibility
Minimum Age: 6 Months
Maximum Age: 11 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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, 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.
Open or close this module Contacts/Locations
Central Contact Person: Moderna Clinical Trials
Telephone: 877-913-3286
Email: clinicaltrials@modernatx.com
Locations: United States, Alabama
Children's of Alabama
[Recruiting]
Birmingham, Alabama, United States, 35233-1711
United States, Arizona
MedPharmics, LLC
[Recruiting]
Phoenix, Arizona, United States, 85015-1105
United States, California
Emmaus Research Center Inc
[Recruiting]
Anaheim, California, United States, 92804-1866
Velocity Clinical Research - Banning - ERN- PPDS
[Recruiting]
Banning, California, United States, 92220-3082
Family Medical Clinic
[Recruiting]
El Monte, California, United States, 91731
Sera Collection Research Services LLC
[Recruiting]
El Monte, California, United States, 91731
Altman Clinical and Translation Research Institute
[Recruiting]
La Jolla, California, United States, 92037
Kaiser Permanente Los Angeles Medical Center
[Recruiting]
Los Angeles, California, United States, 90027
SeroCollection Research Services LLC
[Recruiting]
Montebello, California, United States, 90640-1572
Carey Chronis MD Pediatric, Infant and Adolescent Medicine - FOMAT
[Recruiting]
Ventura, California, United States, 93003-5369
United States, Connecticut
Yale University School of Medicine
[Recruiting]
New Haven, Connecticut, United States, 06519-1712
United States, Florida
Prohealth Research Center
[Recruiting]
Doral, Florida, United States, 33166
University of Florida Jacksonville
[Recruiting]
Jacksonville, Florida, United States, 32209-6511
Kissimmee Clinical Research (KCR)
[Recruiting]
Kissimmee, Florida, United States, 34743
Allied Biomedical Research Institute
[Recruiting]
Miami, Florida, United States, 33155-4630
United States, Georgia
Emory University School of Medicine
[Recruiting]
Atlanta, Georgia, United States, 30303-3031
Iresearch Atlanta, LLC
[Recruiting]
Decatur, Georgia, United States, 30030-3438
United States, Idaho
Velocity Clinical Research - Boise - ERN - PPDS
[Recruiting]
Meridian, Idaho, United States, 83642-6246
United States, Kansas
Alliance for Multispecialty Research -El Dorado
[Recruiting]
El Dorado, Kansas, United States, 67042-2187
United States, Kentucky
Michael W Simon, MD PSC
[Recruiting]
Lexington, Kentucky, United States, 40517-8379
United States, Louisiana
Pennington Biomedical Research Center
[Recruiting]
Baton Rouge, Louisiana, United States, 70809
MedPharmics - Platinum
[Recruiting]
Metairie, Louisiana, United States, 70006-4152
Tulane Medical Center
[Recruiting]
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland School of Medicine
[Recruiting]
Baltimore, Maryland, United States, 21201-1059
The Pediatric Centre of Frederick
[Recruiting]
Frederick, Maryland, United States, 21702
United States, Massachusetts
Massachusetts General Hospital
[Recruiting]
Boston, Massachusetts, United States, 02114
Pediatric Associates of Fall River
[Recruiting]
Fall River, Massachusetts, United States, 02721-1778
University of Massachusetts Medical School
[Recruiting]
Worcester, Massachusetts, United States, 01655
United States, Michigan
Henry Ford Health System
[Recruiting]
Detroit, Michigan, United States, 48202
United States, Minnesota
Clinical Research Institute, Inc - CRN - PPDS
[Recruiting]
Minneapolis, Minnesota, United States, 55402-2700
United States, Mississippi
MediSync Clinical Research Hattiesburg Clinic
[Recruiting]
Petal, Mississippi, United States, 39465
United States, Missouri
Washington University in St. Louis
[Recruiting]
Saint Louis, Missouri, United States, 63110-1010
United States, Nebraska
Meridian Clinical Research (Hastings, Nebraska)
[Recruiting]
Hastings, Nebraska, United States, 68901
Quality Clinical Research - PPDS
[Recruiting]
Omaha, Nebraska, United States, 68114-3723
United States, New Mexico
MedPharmics, LLC
[Recruiting]
Albuquerque, New Mexico, United States, 87102
United States, New York
Certified Research Associates
[Recruiting]
Cortland, New York, United States, 13045-9398
Child Healthcare Associates - East Syracuse
[Recruiting]
East Syracuse, New York, United States, 13057
Stony Brook University Medical Center
[Recruiting]
Stony Brook, New York, United States, 11794-0001
United States, North Carolina
OnSite Clinical Solutions, LLC
[Recruiting]
Charlotte, North Carolina, United States, 28208
Javara Inc. - Winston-Salem
[Recruiting]
Winston-Salem, North Carolina, United States, 27101-4263
United States, Oklahoma
Lynn Health Science Institute - ERN - PPDS
[Recruiting]
Oklahoma City, Oklahoma, United States, 73112-4703
United States, Pennsylvania
Children's Hospital of Philadelphia
[Recruiting]
Philadelphia, Pennsylvania, United States, 19104-4319
Pittsburgh Vaccine Trials Unit - University Center
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Velocity Clinical Research - Providence - ERN - PPDS
[Recruiting]
Warwick, Rhode Island, United States, 02886-1617
United States, South Carolina
Coastal Pediatric Associates
[Recruiting]
Charleston, South Carolina, United States, 29414-5834
Medical University of South Carolina- PPDS
[Recruiting]
Charleston, South Carolina, United States, 29425-8903
Palmetto Pediatrics
[Recruiting]
North Charleston, South Carolina, United States, 29406-9170
United States, Tennessee
Meharry Medical College - Clinical and Translational Research Center & Meharry Medical College - Pediatric Department
[Recruiting]
Nashville, Tennessee, United States, 37208
Vanderbilt University Medical Center
[Recruiting]
Nashville, Tennessee, United States, 37232-0011
United States, Texas
Javara Inc.
[Recruiting]
Dallas, Texas, United States, 75230-2571
BRCR Global Texas
[Recruiting]
Edinburg, Texas, United States, 78539-8462
HD Research Corp
[Recruiting]
El Paso, Texas, United States, 79902-1105
Ventavia Research Group - Platinum - PPDS
[Recruiting]
Houston, Texas, United States, 77008-1398
Baylor College of Medicine
[Recruiting]
Houston, Texas, United States, 77030
West Houston Clinical Research - Hunt
[Recruiting]
Houston, Texas, United States, 77055-1626
Texas Center for Drug Development, Inc
[Recruiting]
Houston, Texas, United States, 77081
Cyfair Clinical Research Center - ERN- PPDS
[Recruiting]
Houston, Texas, United States, 77375-6579
Village Health Partners - HUNT
[Recruiting]
Plano, Texas, United States, 75024
Victoria Clinical Research
[Recruiting]
Port Lavaca, Texas, United States, 77901-5531
Crossroads Clinical Research (Victoria)
[Recruiting]
Port Lavaca, Texas, United States, 77979
Port Lavaca Clinic
[Recruiting]
Port Lavaca, Texas, United States, 77979
Javara, Inc.
[Recruiting]
The Woodlands, Texas, United States, 77382
DM Clinical Research - Pediatric Healthcare of NW Houston
[Recruiting]
Tomball, Texas, United States, 77375-6579
Crossroads Clinical Research (Victoria)
[Recruiting]
Victoria, Texas, United States, 77901
United States, Utah
Tanner Clinic
[Recruiting]
Layton, Utah, United States, 84041
Advanced Clinical Research/Velocity Clinical Research
[Recruiting]
West Jordan, Utah, United States, 84088
Velocity Clinical Research, Salt Lake City
[Recruiting]
West Jordan, Utah, United States, 84088
United States, Virginia
PI-Coor Clinical Research, LLC
[Recruiting]
Burke, Virginia, United States, 22015-1635
Clinical Research Partners, LLC
[Recruiting]
Richmond, Virginia, United States, 23226
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: 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.
Available IPD/Information:

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