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    Summary
    EudraCT Number:2023-000382-14
    Sponsor's Protocol Code Number:mRNA-1273-P203
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2023-12-29
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2023-000382-14
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19
    A.3.2Name or abbreviated title of the trial where available
    TeenCove
    A.4.1Sponsor's protocol code numbermRNA-1273-P203
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04649151
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/481/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorModernaTX, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportModernaTX, Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportBiomedical Advanced Research and Development Authority
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationModernaTX, Inc.
    B.5.2Functional name of contact pointModerna Clinical Trials
    B.5.3 Address:
    B.5.3.1Street Address200 Technology Square
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number1877777-7187
    B.5.6E-mailclinicaltrials@modernatx.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code mRNA-1273
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Spikevax
    D.2.1.1.2Name of the Marketing Authorisation holderModernaTX, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code mRNA-1273.222
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNElasomeran
    D.3.9.2Current sponsor codemRNA-1273
    D.3.9.4EV Substance CodeSUB207171
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Coronavirus Disease 2019
    E.1.1.1Medical condition in easily understood language
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study is designed to primarily evaluate the safety and reactogenicity, and effectiveness 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, reactogenicity, and effectiveness of an optional mRNA-1273 single dose level booster dose (BD); as well as mRNA-1273.222 vaccine against the SARS-CoV- 2 omicron variant.
    E.2.2Secondary objectives of the trial
    • Evaluate the persistence of the immune response of the mRNA-1273 vaccine as assessed by the level of SARS-CoV-2 Spike Protein (S2P)-specific binding antibody (bAb).
    • Evaluate the persistence of the immune response of the mRNA-1273 vaccine as assessed by the level of neutralizing antibody (nAb).
    • Evaluate the effect of the mRNA-1273 vaccine on the incidence of SARS-CoV-2 infection compared with the incidence among placebo recipients.
    • Evaluate the incidence of asymptomatic SARS-CoV-2 infection after vaccination with mRNA-1273 or placebo.
    • Evaluate the incidence of coronavirus disease 2019 (COVID-19) after vaccination with mRNA-1273 or placebo.
    • Evaluate immune response elicited by the mRNA-1273 prototype booster against variant(s) of interest.
    • Evaluate immune response elicited by the mRNA 1273.222 vaccine against the original strain, Omicron BA.4/BA.5, and other variant(s) of interest.
    E.2.3Trial contains a sub-study No
    E.3Principal 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) 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 at or above the third percentile according to World Health Organization 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 1B 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 through 3 months following the second injection (Day 29 in Part 1A and Part 2, and Day 181 in Part 3).

    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.
    E.4Principal 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/≥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-2, SARS-CoV, Middle East Respiratory Syndrome) 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 vapours)
    - 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 intramuscular (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 (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 centre or otherwise involved with the conduct of 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 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 medical intervention after receipt of a vaccine
    • Diagnosis of malignancy within the previous 10 years (excluding nonmelanoma skin cancer)
    • Febrile seizures
    E.5 End points
    E.5.1Primary end point(s)
    • Number of Participants with Solicited Local and Systemic ARs
    • Number of Participants with Unsolicited Adverse Events (AEs)
    • Number of Participants with Serious Adverse Events, Medically Attended AEs, or Adverse Events of Special Interest
    • Number of Participants With Serum Antibody (Ab) Levels that Meet or Exceed the Threshold of Protection From COVID-19
    • Geometric Mean (GM) Value of the Serum Ab Level
    • Seroresponse Rate (SRR) of Vaccine Recipients
    • Number of Participants with AEs Leading to the Discontinuation From Study Post Booster Dose (BD)
    • GM Value of the Serum Ab Level of Original Strain Post BD
    • SRR of Vaccine Recipients of Original Strain Post BD
    • GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against SARS-CoV-2 Omicron Variant at Day 29
    • GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against SARS-CoV-2 Omicron Variant at Day 209
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Up to Day 8 (up to 7 days after each dose)
    • Up to Day 29 (up to 28 days after each dose)
    • Up to Day 751
    • Day 57 (28 days after second dose)
    • Day 57 (28 days after second dose)
    • Day 57 (28 days after second dose)
    • Up to Day 751
    • BD-Day 29
    • BD-Day 29
    • Part 3: Day 29
    • Part 3: Day 209
    E.5.2Secondary end point(s)
    • GM Value of SARS-CoV-2 S2P-Specific bAb
    • GM Value of SARS-CoV-2-Specific nAb
    • Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic) Starting 14 Days after the Second Dose of mRNA-1273 or Placebo
    • Number of Participants With Asymptomatic SARS-CoV-2 Infection Measured by Reverse Transcriptase Polymerase Chain Reaction and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein
    • Number of Participants with a First Occurrence of Symptomatic COVID-19 Starting 14 days After Second Dose of mRNA-1273 or Placebo
    • GM Value of the Serum Ab Level After mRNA-1273 Vaccine Administration Against Circulating Strain
    • SRR After mRNA-1273 Vaccine Administration Against Circulating Strain
    • GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against Original Strain
    • SRR After mRNA-1273.222 Vaccine Administration Against Omicron Variant
    • GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against Other Variants of Interest
    • SRR After mRNA-1273.222 Vaccine Administration Against Original Strain
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Day 1, Day 57 (1 month after dose 2), Day 209 (6 months after dose 2), and Day 394 (1 year after dose 2)
    • Day 1, Day 57 (1 month after dose 2), Day 209 (6 months after dose 2), and Day 394 (1 year after dose 2)
    • Day 43 up to Day 394
    • Day 43 up to Day 394
    • Day 43 up to Day 394
    • Part 1C1 and Part 1C2: Day 29
    • Part 1C1 and Part 1C2: Day 29
    • Part 3: Days 29 and 209
    • Part 3: Days 29 and 209
    • Part 3: Days 29 and 209
    • Part 3: Days 29 and 209
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Reactogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Part 1 A is observer blind, all others are open. Part 1B is a cross over, all others are parallel.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Dominican Republic
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of trial is defined as the date when the last data are available. A participant is considered to have completed the study if the participant has completed all periods of the study including the last visit or the last scheduled procedure.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 4440
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 4440
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 4440
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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