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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-005026-20
    Sponsor's Protocol Code Number:mRNA-1345-P301
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-03-17
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-005026-20
    A.3Full title of the trial
    A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥ 60 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 and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥ 60 Years of Age
    A.4.1Sponsor's protocol code numbermRNA-1345-P301
    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
    B.5.3 Address:
    B.5.3.1Street Address200 Technology Square
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    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 No
    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-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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUnknown
    D.3.9.1CAS number 2692611-88-2
    D.3.9.2Current sponsor codeCX-023398
    D.3.9.3Other descriptive nameRESPIRATORY SYNCYTIAL VIRUS FUSION PROTEIN VACCINE
    D.3.9.4EV Substance CodeSUB181711
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.60 to 1.0
    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 Infection
    E.1.1.1Medical condition in easily understood language
    RSV Infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To evaluate the safety and tolerability of the mRNA 1345 vaccine.
    •To evaluate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV LRTD as compared with placebo within the period of 14 days post-injection up to 12 months post-injection.
    E.2.2Secondary objectives of the trial
    Key Secondary Efficacy Objectives:

    • To evaluate the efficacy of a single dose of mRNA 1345 vaccine in the prevention of a first episode of RSV ARD as compared with placebo within the period of 14 days post-injection up to 12 months post-injection.
    • To evaluate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of first hospitalization associated with RSV ARD or RSV LRTD as compared with placebo within the period of 14 days post-injection up to 12 months post-injection.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults ≥ 60 years of age who are primarily responsible for self care and activities of daily living. Participants may have one or more chronic medical diagnoses (including CHF [including heart failure with preserved ejection fraction] and COPD), but should be medically stable as assessed by the following criteria:
    o Absence of changes in medical therapy within 1 month due to treatment failure or toxicity
    o Absence of medical events qualifying as SAEs within 1 month of the planned study injection on Day 1
    o Absence of known, current, and life-limiting diagnoses, which could continue for the duration of the primary efficacy period (12 months from study injection on Day 1) and which, in the opinion of the investigator, would make completion of the protocol unlikely.
    2. Body mass index from ≥ 18 kg/m2 to ≤ 35 kg/m2.
    3. Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
    4. Able to comply with study requirements.
    E.4Principal exclusion criteria
    1. Participation in another clinical research study where participant has received an investigational product (drug/biologic/device with the exception of investigational RSV products) within 6 months before the planned date of the Day 1 study injection. Current participation in another RSV investigational trial is exclusionary.
    2. History of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication within the 2 months prior to Screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition.
    3. Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, or immune-mediated disease.
    Note: Human immunodeficiency virus (HIV) positive participants with CD4 count ≥ 350 cells/mm3 and an undetectable HIV viral load within the past year (low level variations from 50-500 viral copies which do not lead to changes in antiretroviral therapy) as determined from participant’s medical records, are permitted.
    Note: To clarify, participants with stable autoimmune diseases that do not require systemic immunosuppressants (per Exclusion Criteria #9) are permitted.
    4. Dermatologic conditions that could affect local solicited AR assessments (eg, tattoos, psoriasis patches affecting skin over the deltoid areas).
    5. Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of the mRNA-1345 vaccine or any components of the mRNA-1345 vaccine.
    6. Reported history of bleeding disorder that is considered a contraindication to IM injection or phlebotomy.
    7. History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
    8. Received or plans to receive any nonstudy vaccine (including authorized or approved vaccines for the prevention of coronavirus disease 2019 [COVID 19] regardless of type of vaccine) within 28 days before or after the Day 1 study injection. Nonstudy vaccination(s) should not be delayed.
    9. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study injection. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
    10. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study injection or during the study.
    11. Acute disease at the time of enrollment (defined as the presence of moderate or severe illness with or without fever, or an oral temperature ≥ 37.8°C (100.0°F) on the planned day of vaccine administration).
    12. Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
    13. Known history of poorly controlled hypertension (per determination of the investigator), or systolic blood pressure > 160 mmHg at the Screening or baseline (Day 1) visit.
    14. Known history of hypotension, or systolic blood pressure < 85 mmHg at the Screening or baseline (Day 1) visit.
    15. Diastolic blood pressure > 90 mmHg at the Screening or baseline (Day 1) visit.
    16. Known uncontrolled disorder of coagulation.
    Note: Participants receiving aspirin, clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban, or warfarin for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation and under good control will NOT be excluded.
    17. History of myocarditis, pericarditis, or myopericarditis within 2 months prior to Screening. Participants who have not returned to baseline after their convalescent period will also be excluded.
    18. Donated ≥ 450 mL of blood products < 14 days prior to Screening.
    19. Member of study personnel or is an immediate family member or household member of study personnel.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoint
    • Numbers and percentages of participants with solicited local and systemic adverse reactions (ARs) up to 7 days post-injection.
    • Unsolicited adverse events (AEs) up to 28 days post-injection.
    • Medically attended adverse events (MAAEs), adverse events of special interest (AESIs), serious adverse events (SAEs), and AEs leading to withdrawal up to 24 months post-injection.

    Efficacy Endpoint
    •Vaccine efficacy of mRNA-1345 to prevent a first episode of RSV-LRTD with 2 or more symptoms within the period of 14 days post-injection up to 12 months post-injection.
    •Vaccine efficacy of mRNA-1345 to prevent a first episode of RSV-LRTD with 3 or more symptoms within the period of 14 days post-injection up to 12 months post-injection.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening
    D1 (Baseline)
    D8
    D15
    D29
    D60 then Monthly
    B181
    D365
    D546
    D730/EOS
    E.5.2Secondary end point(s)
    •Vaccine efficacy of mRNA-1345 to prevent a first episode of RSV-ARD within the period of 14 days post-injection up to 12 months post-injection.
    •Vaccine efficacy of mRNA-1345 to prevent first hospitalization associated with RSV-ARD or RSV-LRTD within the period of 14 days post-injection up to 12 months post-injection.

    Key Efficacy Endpoints
    •Vaccine efficacy of mRNA-1345 to prevent all-cause hospitalizations within the period of 14 days post-injection up to 12 months post-injection.
    •Vaccine efficacy of mRNA-1345 to prevent all-cause LRTD within the period of 14 days post-injection up to 12 months post-injection.
    •Vaccine efficacy of mRNA-1345 to prevent first episode of RSV-LRTD with 3 or more symptoms within the period of 14 days post-injection up to 24 months post-injection.
    •Vaccine efficacy of mRNA-1345 to prevent a first episode of RSV-LRTD with 2 or more symptoms within the period of 14 days post-injection up to 24 months post-injection.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening
    D1 (Baseline)
    D8
    D15
    D29
    D60 then Monthly
    B181
    D365
    D546
    D730/EOS
    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 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
    Tolerability
    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) No
    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 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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Bangladesh
    Chile
    Colombia
    Costa Rica
    New Zealand
    Panama
    Singapore
    Puerto Rico
    Taiwan
    Australia
    Canada
    Japan
    Korea, Republic of
    Mexico
    South Africa
    United Kingdom
    United States
    Belgium
    Finland
    Germany
    Poland
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months25
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 3700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33300
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.1In the member state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3365
    F.4.2.2In the whole clinical trial 37000
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
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