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

A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Adolescents 12 to <18 Years of Age

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, reactogenicity, and effectiveness of mRNA-1273 vaccine administered as primary series and a booster dose (BD) to an adolescent population. The study will also evaluate the safety and immunogenicity of an mRNA-1273.222 vaccine against the SARS-CoV- 2 omicron variant as a primary series.

Study Overview

• Status: Active, not recruiting
• Conditions: SARS-CoV-2
• Intervention / Treatment: Biological: Placebo; Biological: mRNA-1273; Biological: mRNA-1273.222

Detailed Description

This is a Phase 2/3 study, with Part 1A (Blinded Phase), Part 1B (Open-label Observational Phase), Part 1C (Booster Dose [BD] Phase), which consists of Part 1C-1 and Part 1C-2, Part 2 (Open-Label), and Part 3 (Open-label). Participants in Part 1A are blinded to their treatment assignment, with participants receiving either 2 active mRNA-1273 vaccine doses or placebo. Part 1B of the study is designed to offer participants whose age group becomes Emergency Use Authorization (EUA) eligible to be unblinded so that participants who received placebo in Part 1A can request 2 doses of open-label mRNA-1273 vaccine. Part 1C-1 of the study will offer participants in Part 1A and Part 1B who are at least 5 months from the last dose, the option to request a homologous BD of mRNA-1273. Part 1C-2 is designed to provide a heterologous BD of mRNA-1273 to eligible participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA and are at least 3 months from the last dose. Part 2 is an open-label design. Participants will receive 2 doses and may receive a booster dose of mRNA-1273 SARS-CoV-2 vaccine. Part 3 is an open-label design. Participants will receive up to 2 doses of mRNA-1273.222 vaccine.

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.

• Study Type: Interventional
• Enrollment (Actual): 4331
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Dominican Republic
  • Distrito Nacional
    • Santo Domingo, Distrito Nacional, Dominican Republic
      • Caimed Dominicana S.A.S
    • Santo Domingo, Distrito Nacional, Dominican Republic
      • Hospital General Regional Dr. Marcelino Velez Santana
    • Santo Domingo, Distrito Nacional, Dominican Republic
      • Hospital Materno Infantil San Lorenzo de Los Mina
    • Santo Domingo, Distrito Nacional, Dominican Republic
      • Instituto Dermatologico y Cirugia de la Piel Dr. H Sede San Cristóbal
    • Santo Domingo, Distrito Nacional, Dominican Republic
      • Instituto Dominicano de Estudios Virologicos IDEV
• United States
  • California
    • Banning, California, United States, 92220
      • Velocity Clinical Research - Banning
    • La Mesa, California, United States, 91942
      • Paradigm Clinical Research
  • Florida
    • Lake Worth, Florida, United States, 33461
      • Altus Research - Hunt - PPDS
    • Orlando, Florida, United States, 32829
      • Accel Research Sites - Nona Pediatric Center - ERN - PPDS
  • Georgia
    • Chamblee, Georgia, United States, 30341
      • Tekton Research - Georgia - PPDS
    • Columbus, Georgia, United States, 31904
      • IACT Health - Roswell - IACT - HyperCore - PPDS
    • Macon, Georgia, United States, 31210
      • Meridian Clinical Research - (Macon Georgia) - Platinum - PPDS
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research - Boise - PPDS
  • Illinois
    • Chicago, Illinois, United States, 60618
      • Olivo Medical and Wellness Center
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Velocity Clinical Research - Valparaiso
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Meridian Clinical Research (Sioux City - Iowa)
  • Kansas
    • El Dorado, Kansas, United States, 67042
      • Alliance for Multispecialty Research -El Dorado
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clin-Trials
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Velocity Clinical Research - Metairie - PPDS
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School, Molecu
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute, Inc - CRN - PPDS
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Velocity Clinical Research - Gulfport - PPDS
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research - Platinum - PPDS
  • Nebraska
    • Hastings, Nebraska, United States, 68901
      • Meridian Clinical Research (Hastings-Nebraska) - Platinum - PPDS
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research - HyperCore - PPDS
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Velocity Clinical Research - Albuquerque - PPDS
  • New York
    • East Syracuse, New York, United States, 13210
      • Child Healthcare Associates - East Syracuse
    • Endwell, New York, United States, 13901
      • Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Velocity Clinical Research - Cincinnati - PPDS
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute PC - CRN - PPDS
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Cyn3rgy Research - ClinEdge - PPDS
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research - Providence - PPDS
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Associates
    • Charleston, South Carolina, United States, 29414
      • Meridian Clinical Research - Charleston, SC
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Texas
    • Austin, Texas, United States, 78705
      • Benchmark Research
    • Corpus Christi, Texas, United States, 78404
      • Coastal Bend Research Center
    • Frisco, Texas, United States, 75033
      • ACRC Trials
    • Houston, Texas, United States, 77064
      • DM Clinical Research - Kool Kids Pediatrics - ERN - PPDS
    • San Antonio, Texas, United States, 78229
      • Tekton Research
    • San Antonio, Texas, United States, 78244
      • Tekton Research
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc. - PPDS
  • Utah
    • Bountiful, Utah, United States, 84010
      • Cope Family Medicine - Ogden Clinic - CCT
    • Kaysville, Utah, United States, 84037
      • Wee Care Pediatrics - Kaysville
    • Murray, Utah, United States, 84107
      • Cottonwood Pediatrics
    • South Ogden, Utah, United States, 84405
      • South Ogden Family Medicine/Ogden Clinic - CCT Research
    • Syracuse, Utah, United States, 84075
      • Alliance for Multispecialty Research
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research - Jordan Valley - ERN - PPDS
  • Virginia
    • Norfolk, Virginia, United States, 68701
      • Meridian Clinical Research (Norfolk, Virginia)
    • Portsmouth, Virginia, United States, 23703
      • Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

For Part 1A, Part 2 and Part 3:

• 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), on the day of the second injection (Day 29 in Parts 1A and Part 2, and Day 181 in Part 3); 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); and has agreed to continue adequate contraception or abstinence through 3 months following the second injection (Day 29 in Part 1A and Part 2, and Day 181 in Part 3).

For Part 1B:

• Participants must have been previously enrolled in mRNA-1273-P203 study.
• Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of the first injection (Open-Label-Day 1) and on the day of the second injection (Open-Label-Day 29).

For Part 1C-1 Homologous Booster Dose:

• Participants must have been previously enrolled in the mRNA-1273-P203 study, are actively participating in Part 1A or Part 1B and are least 5 months from the last dose.
• Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of the first injection (BD-Day 1).

Part 1C-2 Heterologous Booster Dose:

• Male or female, 12 to < 18 years of age at the time of consent who, in the opinion of the investigator, is in good general health based on review of medical history and screening physical examination AND has completed non-Moderna primary COVID-19 vaccination series under EUA (for example, Pfizer) at least 3 months from consent.

Exclusion Criteria:

For Part 1A, Part 2, and Part 3:

• Has a known history of SARS-CoV-2 infection within 2 weeks prior to administration of investigational product (IP) or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection of COVID-19 within 2 weeks prior to administration of IP (Part 2 participants only). For Part 3 participants, known history of SARS-CoV-2 infection within 90 days prior to administration of IP or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 90 days prior to administration of IP.
• Travel outside of the United States or home country (Part 2 and Part 3 only) 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 (C)/≥100.4°Farenheit (F). 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-2, 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 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 IP or plans for receipt of any licensed vaccine within 28 days before and/or after each 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 milliliters (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

For Part 1C-1 and Part 1C-2:

• 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°C/≥ 100.4°F. 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.
• 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.

• History of a diagnosis or condition (after enrolment in Part 1A) that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety:

  • Suspected active hepatitis
  • Has a bleeding disorder that is considered a contraindication to IM injection or phlebotomy
  • Dermatologic conditions that could affect local solicited AR assessments
  • History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine
  • Diagnosis of malignancy (excluding nonmelanoma skin cancer)

• Receipt of:

  • Any authorized or licensed vaccine within 28 days before the first dose of IP or plans for receipt of any licensed vaccine through 28 days following the last dose of IP or any seasonal influenza vaccine within 14 days before the first dose of IP or plans for receipt of any seasonal influenza vaccine 14 days following the last dose of IP.

• Participated in an interventional clinical study, other than mRNA-1273-P203 study, within 28 days prior to the Screening Visit (Day 0 [for Part 1C-1], BD-Day 0 [for Part 1C-2]) or plans to do so while participating in this study.

Part 1C-2 Heterologous Booster Dose:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Part 1A (Blinded Phase): 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
Experimental: mRNA-1273 BD; Part 1C-1 (BD Phase): Participants will receive 1 IM injection of mRNA-1273 (50 ug) on BD-Day 1, 5 months after the last dose of Part 1A and 1B. Part 1C-2 (BD Phase): Participants will receive 1 IM injection of mRNA-1273 (50 ug) on BD-Day 1, at least 3 months post-last dose.	Biological: mRNA-1273; Sterile liquid for injection
Experimental: mRNA-1273; Part 1A (Blinded Phase): Participants will receive 2 intramuscular (IM) injections of mRNA-1273 (100 microgram [ug] each), 28 days apart, on Day 1 and Day 29. Part 1B (Open-Label Phase): Participants who cross over from placebo in Part 1A to Part 1B will receive 2 IM injections of mRNA-1273 (100 ug each), 28 days apart on Open Label Day 1 and Open Label Day 29. Part 2 (Open-Label): Participants will receive 2 IM injections of mRNA-1273 (50 ug each), 28 days apart, on Day 1 and Day 29 and may receive a booster dose on Day 149.	Biological: mRNA-1273; Sterile liquid for injection
Experimental: mRNA-1273.222; Part 3 (Open-Label): Participants will receive up to 2 IM injections of mRNA-1273.222 (50 ug each), 6 months apart, on Day 1 and Day 181.	Biological: mRNA-1273.222; Sterile solution for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), or Adverse Events of Special Interest (AESI)		Up to Day 751
Number of Participants With Serum Antibody (Ab) Levels that Meet or Exceed the Threshold of Protection From COVID-19	Acceptable serum Ab threshold as predefined for the study.	Day 57
Geometric Mean (GM) Value of the Serum Ab Level		Day 57
Seroresponse Rate (SRR) of Vaccine Recipients		Day 57
Number of Participants with AEs Leading to Discontinuation From Study Post BD		Up to Day 751
GM Value of the Serum Ab Level Against Ancestral Strain Post BD		BD-Day 29
SRR of Vaccine Recipients Against Ancestral Strain Post BD at BD-Day 29		BD-Day 29
GM Value of the Serum Ab Level Against Ancestral Strain Post Dose 2		Day 57
SRR of Vaccine Recipients Against Ancestral Strain Post Dose 2		Day 57
GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against SARS-CoV-2 Omicron Variant		Day 29
GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against Ancestral Strain		Day 29
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)		Up to Day 187 (7 days after injection/each injection)
Number of Participants with Unsolicited Adverse Events (AEs)		Up to Day 208 (28 days after dose/each dose)
Number of Participants with AEs Leading to Discontinuation from Study from Dose 1		Up to Day 361

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic) Starting 14 Days after the Second Dose of mRNA-1273 or Placebo	Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.	Day 43 up to Day 394
Number of Participants With Asymptomatic SARS-CoV-2 Infection Measured by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein		Day 43 up to Day 394
Number of Participants with a First Occurrence of Symptomatic COVID-19 Starting 14 days After Second Dose of mRNA-1273 or Placebo	Clinical signs indicative of symptomatic COVID-19 as predefined for the study.	Day 43 up to Day 394
GM Value of SARS-CoV-2 Spike Protein (S2P)-Specific Binding Antibody (bAb)		Day 1, Day 57 (1 month after Dose 2), Day 209 (6 months after Dose 2), and Day 394 (1 year after Dose 2)
GM Value of SARS-CoV-2-Specific Neutralizing Antibody (nAb)		Day 1, Day 57 (1 month after Dose 2), Day 209 (6 months after Dose 2), and Day 394 (1 year after Dose 2)
GM Value of the Serum Ab Level After mRNA-1273 Vaccine Administration Against Circulating Strain		Day 29
SRR After mRNA-1273 Vaccine Administration Against Circulating Strain		Day 29
SRR After mRNA-1273.222 Vaccine Administration Against Omicron Variant		Day 29
SRR After mRNA-1273.222 Vaccine Administration Against Ancestral Strain		Day 29
GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against Other Variants of Interest		Day 29

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.
• Collaborators: Biomedical Advanced Research and Development Authority

Publications and helpful links

General Publications

• Ali K, Berman G, Zhou H, Deng W, Faughnan V, Coronado-Voges M, Ding B, Dooley J, Girard B, Hillebrand W, Pajon R, Miller JM, Leav B, McPhee R. Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents. N Engl J Med. 2021 Dec 9;385(24):2241-2251. doi: 10.1056/NEJMoa2109522. Epub 2021 Aug 11.

Helpful Links

• Click here to access the website, http://TeenCoveStudy.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): December 9, 2020
• Primary Completion (Estimated): June 9, 2024
• Study Completion (Estimated): December 9, 2024

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 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; Variant; Omicron; COVID-19 Vaccine; mRNA-1273 vaccine; mRNA-1273; mRNA-1273.222 vaccine; SARS-CoV-2 VOC; SARS-CoV-2 VOC vaccine
• Other Study ID Numbers: mRNA-1273-P203; 2023-000382-14 (EudraCT Number)

Drug and device information, study documents

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