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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)

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ClinicalTrials.gov Identifier: NCT04649151
Recruitment Status : Active, not recruiting
First Posted : December 2, 2020
Last Update Posted : August 20, 2021
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
ModernaTX, Inc.

Tracking Information
First Submitted Date  ICMJE November 30, 2020
First Posted Date  ICMJE December 2, 2020
Last Update Posted Date August 20, 2021
Actual Study Start Date  ICMJE December 9, 2020
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2021)
  • Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 36 (7 days after each dose) ]
  • Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 57 (28 days after each dose) ]
  • Number of Participants with Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), or Adverse Events of Special Interest (AESI) of Multisystem Inflammatory Syndrome in Children (MIS-C) [ Time Frame: Up to Day 394 (1 year after second dose) ]
  • Number of Participants With Serum Antibody (Ab) Levels that Meet or Exceed the Threshold of Protection From COVID-19 [ Time Frame: Day 57 (28 days after second dose) ]
    Acceptable serum Ab threshold as predefined for the study.
  • Geometric Mean (GM) of the Serum Ab Level [ Time Frame: Day 57 (28 days after second dose) ]
  • Seroresponse Rate of Vaccine Recipients [ Time Frame: Day 57 (28 days after second dose) ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2020)
  • Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 8 (7 days after first dose) and up to Day 36 (7 days after second dose) ]
  • Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 57 (28 days after each dose) ]
  • Number of Participants with Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), or Adverse Events of Special Interest (AESI) [ Time Frame: Up to Day 394 (1 year after second dose) ]
  • Number of Participants Who have Reached the Acceptable Threshold for the Serum Ab Level at Day 57 [ Time Frame: Day 57 (28 days after second dose) ]
    Acceptable serum Ab threshold as predefined for the study.
  • Comparison of the Geometric Mean of the Serum Neutralizing Antibody (nAb) level against the Geometric Mean of the Serum nAb level in Study mRNA-1273-P301 (NCT04470427) [ Time Frame: Day 57 (28 days after second dose) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2021)
  • GM of SARS-CoV-2 Spike Protein (S2P)-Specific Binding Antibody (bAb) [ Time Frame: 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 of SARS-CoV-2-Specific Neutralizing Antibody (nAb) [ Time Frame: Day 1, Day 57 (1 month after dose 2), Day 209 (6 months after dose 2), and Day 394 (1 year after dose 2) ]
  • Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic) Starting 14 Days after the Second Dose of mRNA-1273 or Placebo [ Time Frame: Day 43 up to Day 394 ]
    Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.
  • 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 [ Time Frame: 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 [ Time Frame: Day 43 up to Day 394 ]
    Clinical signs indicative of symptomatic COVID-19 as predefined for the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2020)
  • Geometric Mean Value of SARS-CoV-2 Spike Protein (S2P)-specific binding antibody (bAb) [ Time Frame: Day 1, Day 57 (1 month after dose 2), Day 209 (6 months after dose 2), and Day 394 (1 year after dose 2) ]
  • Geometric Mean Value of SARS-CoV-2-specific nAb [ Time Frame: Day 1, Day 57 (1 month after dose 2), Day 209 (6 months after dose 2), and Day 394 (1 year after dose 2) ]
  • Number of Participants with a SARS-CoV-2 Infection Starting on Day 57 [ Time Frame: Day 57 up to Day 394 ]
    Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.
  • Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo [ Time Frame: Day 29 (second dose) up to Day 394 (1 year after second dose) ]
    Clinical signs indicative of COVID-19 as predefined for the study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

This is a 2-part Phase 2/3 study, with Part A (Blinded Phase) and Part B (Open-label Observational Phase). Participants in Part A are blinded to their treatment assignment, with participants receiving either 2 active mRNA-1273 vaccine doses or placebo. Part B of the study is designed to offer participants whose age group becomes EUA eligible to be unblinded so that participants who received placebo in Part A can request 2 doses of open-label mRNA-1273 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Part A is observer-blind. During Part B, as their age group becomes Emergency Use Authorization (EUA) eligible, participants may request to be unblinded by scheduling a Participant Decision clinic visit.
Primary Purpose: Prevention
Condition  ICMJE SARS-CoV-2
Intervention  ICMJE
  • Biological: mRNA-1273
    Sterile liquid for injection
  • Biological: Placebo
    0.9% sodium chloride (normal saline) injection
Study Arms  ICMJE
  • Experimental: mRNA-1273

    Part A (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 B (Open-Label Phase): Participants who continue in Part B, will receive 2 IM injections of mRNA-1273 (100 ug each), 28 days apart on Open Label Day 1 and Open Label Day 29.

    Intervention: Biological: mRNA-1273
  • Placebo Comparator: Placebo
    Part A (Blinded Phase): Participants will receive 2 IM injections of mRNA-1273 matching placebo, 28 days apart, on Day 1 and Day 29.
    Intervention: Biological: Placebo
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 Aug 11. doi: 10.1056/NEJMoa2109522. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 2, 2021)
3732
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2020)
3000
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

For Part A:

  • 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); and has agreed to continue adequate contraception through 3 months following the second injection (Day 29).

For Part B:

  • Participants who were previously enrolled in the mRNA-1273 P203 study and chose to be unblinded.
  • 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).

Exclusion Criteria:

  • 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 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 (Day 1) or plans for receipt of any licensed vaccine through 28 days following any study injection
    • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04649151
Other Study ID Numbers  ICMJE mRNA-1273-P203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ModernaTX, Inc.
Study Sponsor  ICMJE ModernaTX, Inc.
Collaborators  ICMJE Biomedical Advanced Research and Development Authority
Investigators  ICMJE Not Provided
PRS Account ModernaTX, Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP