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    Summary
    EudraCT Number:2024-000502-15
    Sponsor's Protocol Code Number:mRNA-1345-P202
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2024-12-05
    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 number2024-000502-15
    A.3Full title of the trial
    A Phase 2, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus
    A.4.1Sponsor's protocol code numbermRNA-1345-P202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT06097299
    A.5.4Other Identifiers
    Name:2023-506271-96-00Number:EU CT
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    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.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 pointClinical Trials Support Center
    B.5.3 Address:
    B.5.3.1Street Address325 Binney Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1877-777-7187
    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.3.1Product namemRNA-1345
    D.3.2Product code mRNA-1345
    D.3.4Pharmaceutical form Solution for 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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
    Respiratory Syncytial Virus
    E.1.1.1Medical condition in easily understood language
    Viral Diseases
    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
    Part A: To evaluate the safety and reactogenicity of a single study injection.
    Part B: To evaluate the incidence of respiratory syncytial virus (RSV)-respiratory tract disease (RTD) during 6 months after re-enrollment.
    E.2.2Secondary objectives of the trial
    Part A: To evaluate the immunogenicity of a single study injection.
    Part B: To evaluate the safety of a single study injection administered in Part A during 6 months after re-enrollment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    Part A (Cohort 1):
    - 2 to <5 years of age at Day 1.
    - Healthy, or with stable chronic conditions increasing the risk of RSV disease, per the clinical judgment of the Investigator.

    Part A (Cohort 2):
    - 5 to <18 years of age at Day 1.
    - Participants with stable chronic conditions increasing the risk of RSV disease.
    - Female participants of child-bearing potential may be enrolled in the study, if the participant: 1) has a negative urine pregnancy test at Screening and on the day of injection (Day 1); 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to Day 1; 3) has agreed to continue adequate contraception through 90 days following injection; and 4) is not currently breastfeeding.

    Part B (Cohort 1 Re-enrollment):
    - Enrolled and dosed in Part A of Cohort 1; either reached end of study (EOS) for Part A or were dosed and subsequently discontinued from study for various reasons. This includes participants who were lost to follow-up, if they can be re-engaged.
    E.4Principal exclusion criteria
    Key Exclusion Criteria
    All Cohorts (Part A Only):
    - Acutely ill or febrile (temperature ≥38.0°Celsius [100.4°Fahrenheit]) within 72 hours prior to or at the Screening Visit or Day 1.
    - History of a diagnosis or condition that, in the judgment of the Investigator, may affect study assessment or compromise participant safety.
    - Has received or plans to receive any licensed or authorized vaccine ≤14 days prior to the study vaccine injection (Day 1) or plans to receive a licensed or authorized vaccine within 14 days after the study vaccine injection.
    - Receipt of any prior systemic immunosuppressants. Short courses (<7 days) of oral corticosteroids are allowed if completed at least 3 months prior to enrollment.
    - Receipt of RSV monoclonal antibodies within 6 months prior to enrollment in the study.
    - Participated in an interventional clinical study within 28 days (6 months for a study assessing a product unlicensed/unauthorized in this age group in country of residence at time of enrollment) prior to the day of enrollment or plans to do so while enrolled in this study.

    Part B (Cohort 1 Re-enrollment):
    - Participant is currently enrolled in another interventional clinical study.
    E.5 End points
    E.5.1Primary end point(s)
    Outcome Measure #1: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
    Outcome Measure #2: Number of Participants with Unsolicited Adverse Events (AEs)
    Outcome Measure #3: Number of Participants With Medically Attended AEs (MAAEs)
    Outcome Measure #4: Number of Participants With Adverse Events of Special Interest (AESIs)
    Outcome Measure #5: Number of Participants With Serious Adverse Events (SAEs)
    Outcome Measure #6: Number of Participants With AEs Leading to Discontinuation
    Outcome Measure #7: Number of Participants With RSV-RTD
    Outcome Measure #8: Number of Participants With RSV- Lower Respiratory Tract Disease (LRTD)
    Outcome Measure #9: Number of Participants With Severe RSV- LRTD
    Outcome Measure #10: Number of Participants With Very Severe RSV- LRTD
    Outcome Measure #11: Number of Participants With RSV Hospitalization
    E.5.1.1Timepoint(s) of evaluation of this end point
    Outcome Measure #1: Up to 7 days postinjection
    Outcome Measure #2: Up to 28 days postinjection
    Outcome Measure #3, #4, #5, and #6: Day 1 through EOS (Month 6)
    Outcome Measure #7 to #11: Part B Day 1 through Part B EOS (Month 6)
    E.5.2Secondary end point(s)
    Outcome Measure #1: Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody
    Outcome Measure #2: Geometric Mean Concentration (GMC) of Serum RSV Prefusion F Binding Antibody
    Outcome Measure #3: Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations
    Outcome Measure #4: Number of Participants With Seroresponse in RSV Neutralizing Antibody
    Outcome Measure #5: Number of Participants With AESIs and SAEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Outcome Measure #1 and #2: Day 1, Day 29, and Month 6
    Outcome Measure #3 and #4: Baseline to Day 29 and Month 6
    Outcome Measure #5: Part B Day 1 to Part B Month 6
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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
    Immunogenicity
    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) No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    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 trial3
    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
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    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 months5
    E.8.9.2In all countries concerned by the trial days12
    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: 340
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 250
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 90
    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 340
    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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