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)

  • STATUS
    Recruiting
  • End date
    May 28, 2024
  • participants needed
    3724
  • sponsor
    ModernaTX, Inc.
Updated on 22 April 2022
Accepts healthy volunteers

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. The study will also evaluate the safety of an optional mRNA-1273 single dose level booster dose (BD).

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 and Part 2 (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 of mRNA-1273 SARS-CoV-2 vaccine and a BD.

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.

Details
Condition SARS-CoV-2
Treatment Placebo, mRNA-1273
Clinical Study IdentifierNCT04649151
SponsorModernaTX, Inc.
Last Modified on22 April 2022

Eligibility

Yes No Not Sure

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
For Part 1A and Part 2
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), and on the day of the BD (Day 149) in Part 2; 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) and BD (Day 149) in Part 2
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

Pregnant or breastfeeding
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
For Part 1A and Part 2
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
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)
Current use of any inhaled substance (for example, tobacco or cannabis smoke, nicotine vapors)
Travel outside of the United States or home country (Part 2 only) in the 28 days prior to 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
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
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
History of chronic smoking (≥1 cigarette a day) within 1 year of the Screening Visit (Day 0)
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
Dermatologic conditions that could affect local solicited AR assessments
Intravenous blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment
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
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
Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit (Day
) or plans to donate blood products during the study
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 immunodeficiencyvirus (HIV) infection
Suspected active hepatitis
Has a bleeding disorder that is considered a contraindication to IM injection orphlebotomy
Dermatologic conditions that could affect local solicited AR assessments
History of anaphylaxis, urticaria, or other significant AR requiring medicalintervention after receipt of a vaccine
Diagnosis of malignancy within the previous 10 years (excluding nonmelanomaskin cancer)
Febrile seizures
For Part 1B
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)
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 for potential participants in Part 1C-1) 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
investigational product (IP) or plans (COVID-19 vaccines are not exclusionary)
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 (BD-Day 0) or plans to do so while participating in this study
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 immunodeficiencyvirus (HIV) infection
Suspected active hepatitis
Has a bleeding disorder that is considered a contraindication to IM injection orphlebotomy
Dermatologic conditions that could affect local solicited AR assessments
History of anaphylaxis, urticaria, or other significant AR requiring medicalintervention after receipt of a vaccine
Diagnosis of malignancy within the previous 10 years (excluding nonmelanomaskin cancer)
Febrile seizures
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
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