A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19

Study Purpose

The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the safety and reactogenicity of a single dose level of mRNA-1273 vaccine administered in 2 doses 28 days apart to an adolescent population.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participants 12 to <18 years of age at the time of consent (Screening Visit, Day 0) who, in the opinion of the Investigator, are in good general health based on review of medical history and screening physical examination.
  • - Investigator assessment that the participant, in the case of an emancipated minor, or parent(s)/legally acceptable representative(s) [LAR(s)] understand and is willing and physically able to comply with protocol-mandated follow up, including all procedures and provides written informed consent/assent.
  • - Body mass index (BMI) at or above the third percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit (Day 0) - Female participants of nonchildbearing potential may be enrolled in the study.
Nonchildbearing potential is defined as premenarche or surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy).
  • - Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test at Screening (Day 0), on the day of the first injection (Day 1), and on the day of the second injection (Day 29); has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1); has agreed to continue adequate contraception through 3 months following the second injection (Day 29); and is not currently breastfeeding.

Exclusion Criteria:

  • - Known history of SARS-CoV-2 infection or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to vaccine administration.
  • - Travel outside of the United States in the 28 days prior to the Screening Visit (Day 0) - Pregnant or breastfeeding.
  • - Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0).
Fever is defined as a body temperature ≥38.0°Celsius/≥100.4°Farenheit. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the Investigator.
  • - Prior administration of an investigational coronavirus (for example, SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]) vaccine.
  • - Current treatment with investigational agents for prophylaxis against COVID-19.
  • - Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
  • - Current use of any inhaled substance (for example, tobacco or cannabis smoke, nicotine vapors) - History of chronic smoking (≥1 cigarette a day) within 1 year of the Screening Visit (Day 0) - History of illegal substance use or alcohol abuse within the past 2 years.
This exclusion does not apply to historical cannabis use that was formerly illegal in the participant's state but is legal at the time of screening.
  • - History of a diagnosis or condition that, in the judgment of the Investigator, may affect study endpoint assessment or compromise participant safety, specifically: - Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection.
  • - Suspected active hepatitis.
  • - Has a bleeding disorder that is considered a contraindication to IM injection or phlebotomy.
  • - Dermatologic conditions that could affect local solicited adverse reaction (AR) assessments.
  • - History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine.
  • - Diagnosis of malignancy within the previous 10 years (excluding nonmelanoma skin cancer) - Febrile seizures.
  • - Receipt of: - Any licensed vaccine within 28 days before the first dose of investigational product (IP) or plans for receipt of any licensed vaccine through 28 days following the last dose of IP.
  • - Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of enrollment (for corticosteroids, ≥20 mg/day prednisone equivalent).
Topical tacrolimus is allowed if not used within 14 days prior to the day of enrollment. Participants may have visits rescheduled for enrollment if they no longer meet this criterion within the Screening Visit window. Inhaled, nasal, and topical steroids are allowed.
  • - Intravenous blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment.
  • - Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit (Day 0) or plans to donate blood products during the study.
  • - Participated in an interventional clinical study within 28 days prior to the Screening Visit (Day 0) or plans to do so while participating in this study.
- Is an immediate family member or has a household contact who is an employee of the research center or otherwise involved with the conduct of the study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04649151
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ModernaTX, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryU.S. Fed
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

SARS-CoV-2
Study Website: View Trial Website
Additional Details

Please access http://TeenCoveStudy.com for additional information, such as Study Overview, Participation, Site Locations along with contact numbers for each location for the study.

Arms & Interventions

Arms

Experimental: mRNA-1273

Participants will receive 1 intramuscular (IM) injection of 100 microgram (ug) mRNA-1273 on Day 1 and on Day 29.

Placebo Comparator: Placebo

Participants will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.

Interventions

Biological: - mRNA-1273

Sterile liquid for injection

Biological: - Placebo

0.9% sodium chloride (normal saline) injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you. Please note all sites listed may not currently be active in the trial. Please continue to check back for additional site locations.

Velocity Clinical Research - Banning
Banning, California, United States, 92220
See if you Qualify
Paradigm Clinical Research
La Mesa, California, United States, 91942
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Accel Research Sites - Nona Pediatric Center
DeLand, Florida, United States, 32720
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Tekton Research
Chamblee, Georgia, United States, 30341
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Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
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Velocity Clinical Research - Boise
Meridian, Idaho, United States, 83642
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Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, United States, 46383
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Johnson County Clinical Trials
Lenexa, Kansas, United States, 66219
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Medpharmics - Metairie
Metairie, Louisiana, United States, 70006
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University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
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Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
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Medpharmics - Gulfport
Gulfport, Mississippi, United States, 39503
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Medpharmics - Albuquerque
Albuquerque, New Mexico, United States, 87102
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Child Healthcare Associates
Liverpool, New York, United States, 13090
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Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, United States, 45242
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Lynn Health Sciences Institute
Oklahoma City, Oklahoma, United States, 73112
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Velocity Clinical Research - Providence
Warwick, Rhode Island, United States, 02886
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Coastal Pediatric Associates
Charleston, South Carolina, United States, 29414
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Benchmark Research
Austin, Texas, United States, 78705
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Crossroads Clinical Research
Corpus Christi, Texas, United States, 78413
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Kool Kids Pediatrics
Houston, Texas, United States, 77065
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ACRC Trials
Plano, Texas, United States, 75024
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Tekton Research
San Antonio, Texas, United States, 78240
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Tekton Research
San Antonio, Texas, United States, 78244
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Velocity Clinical Research - Salt Lake City - Jordan Valley
West Jordan, Utah, United States, 84088
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