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    Summary
    EudraCT Number:2024-000122-18
    Sponsor's Protocol Code Number:mRNA-1345-P101
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2024-04-30
    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 number2024-000122-18
    A.3Full title of the trial
    A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose
    Escalation Study to Evaluate the Safety, Reactogenicity, and
    Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting
    Respiratory Syncytial Virus (RSV), in Healthy Younger Adults Aged 18
    to 49 Years, Women of Child-Bearing Potential Aged 18 to 40 Years,
    Healthy Older Adults Aged 65 to 79 Years, Japanese Older Adults Aged
    ≥ 60 Years, and RSV-Seropositive Children Aged 12 to 59 Months
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive
    A.4.1Sponsor's protocol code numbermRNA-1345-P101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04528719
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/195/2023
    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 pointModerna Clinical Trials
    B.5.3 Address:
    B.5.3.1Street Address 325 Binney Street
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number1 877 777 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 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.3.1Product namemRNA-1345
    D.3.2Product code mRNA-1345
    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.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
    RSV
    E.1.1.1Medical condition in easily understood language
    RSV
    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 main objectives of this trial are to:

    - evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults, including Japanese older adults,
    - evaluate the tolerability and reactogenicity of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults,
    - evaluate the tolerability and reactogenicity of a booster injection of mRNA-1345 given approximately 12 and 24 months after the primary injection in older adults, and
    - evaluate the tolerability and reactogenicity of 3 injections of 2 dose levels of mRNA-1345 given 56 days apart in RSV-seropositive children.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are to:

    - evaluate the antibody (Ab) response to each vaccine dose level in healthy younger adults, women of child-bearing potential, and older adults, including Japanese older adults,
    - evaluate the Ab response to both 1 and 3 vaccine injections in healthy younger adults at the middle dose level of mRNA-1345,
    - evaluate the Ab response to a vaccine booster injection given approximately 12 and 24 months after the primary injection in older adults, and
    - evaluate the Ab response to each vaccine dose level in RSV-seropositive children.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Healthy young adults ≥18 to ≤49 years of age, women of child-bearing potential ≥18 to ≤40 years of age, healthy older adults ≥65 to <80 years of age, Japanese older adults ≥ 60 years of age, and children ≥12 to < 60 months of age.
    - Willing and physically able to comply with protocol-mandated follow-up, including all procedures.
    - Adult participant or parent(s)/legal guardian(s) of pediatric participants has provided written informed consent for participation in this study, including all evaluations and procedures as specified by the protocol.

    Specific inclusion criteria for adults (younger adults, women of child-bearing potential, and older adults [including Japanese older adults]):

    - Has a body mass index from ≥18 kilograms (kg)/meter (m)^2 to ≤35 kg/m^2.
    - Female participants of non-child-bearing potential. This criterion does not apply for women of child-bearing potential Cohorts 12, 13, and 14.
    - 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 vaccination; 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to vaccination; 3) has agreed to continue adequate contraception through 3 months following the last injection; and 4) is not currently breastfeeding.

    Specific inclusion criteria for children 12 to 59 months of age:

    - Seropositive for RSV-neutralizing Abs at Screening.
    - Has received routine immunizations appropriate for age per local guidance.
    - Current height and weight above the third percentile for age.

    Specific inclusion criteria for Japanese older adults:

    - Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan.
    E.4Principal exclusion criteria
    - Has Screening laboratory values Grade ≥1 (younger adult, women of child-bearing potential, and pediatric participants) or >Grade 1 (older adult participants, including Japanese older adult participants).
    - Is acutely ill or febrile on the day of the first injection.
    - Has a significant medical history, including but not limited to:

    - Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection.
    - Chronic hepatitis or suspected active hepatitis.
    - Bleeding disorder that is considered a contraindication to intramuscular (IM) injection or phlebotomy.
    - Dermatologic conditions that could affect local solicited adverse reaction (AR) assessments.
    - Any history of allergic or anaphylactic reactions following a vaccination that required medical intervention.
    - Autoimmune disease except for Hashimoto's disease.
    - Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of enrollment. Topical tacrolimus is allowed if not used within 14 days prior to the day of enrollment. Inhaled, nasal, and topical steroids are allowed.
    - Intravenous blood products (red cells, platelets, and immunoglobulins [Ig]) within 3 months prior to enrollment.

    - Has received or plans to receive any licensed or authorized vaccine, to include Coronavirus Disease 2019 (COVID-19) vaccines, ≤ 28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection. Non-study vaccinations should not be delayed.
    - Has a history of myocarditis, pericarditis, or myopericarditis.

    Specific exclusion criteria for older adults (Cohorts 7-11 and 15):

    - Known history of poorly controlled hypertension (per determination of the Investigator) or systolic blood pressure >160 millimeters of mercury (mmHg) at the Screening visit.
    - Known history of hypotension or systolic blood pressure <85 mmHg at the Screening visit.
    - Poorly controlled diabetes mellitus (per determination of the Investigator).
    - Diagnosis of significant chronic pulmonary disease (per determination of the Investigator) (such as, chronic obstructive pulmonary disease, asthma).
    - Significant chronic cardiovascular disease (per determination of the Investigator).
    - Resides in a nursing home.
    - Anticipates the need for immunosuppressive treatment at any time during participation in the study.
    - Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer and cervical carcinoma in-situ).

    Specific exclusion criteria for children 12 to 59 months of age (Cohorts 5 and 6):

    - Has received any monoclonal antibody at any time prior to the Screening visit.
    - Prior hospitalization for RSV disease in the last 2 years.
    - Receipt of any prior systemic immunosuppressants or immune-modifying drugs.
    - Any history of febrile seizures (inclusive of single simple febrile seizure).
    - History of epilepsy.
    - History of meningitis.
    E.5 End points
    E.5.1Primary end point(s)
    - Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
    - Number of Participants with Unsolicited Adverse Events (AEs)
    - Number of Participants with Serious AEs or Medically Attended AEs (MAAEs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Up to Day 737 (7 days after each injection)
    - Up to Day 758 (28 days after the last injection)
    - Up to Day 1095 (End of Study)
    E.5.2Secondary end point(s)
    - Geometric Mean Titer (GMT) of Serum RSV Neutralizing and Binding Antibodies (Abs)
    - Geometric Mean Fold-Rise of Postbaseline/Baseline Ab Titers
    - Proportion of Participants with ≥2-fold and ≥4-fold Increases in Ab Titers from Baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, 14, and 15), up to Day 281 (Cohort 3), and up to Day 1095 (Cohorts 7, 8, 9, 10, and 11). Time frame applies to all secondary endpoints.
    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 and immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Reactogenicity and immunogenicity
    E.7.2Therapeutic exploratory (Phase II) No
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    The study is observer blind. For older adult cohorts, the second booster injection is open label.
    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 trial15
    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 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 study (EOS) is defined as completion of the last visit of the last participant in the study or last scheduled procedure for the last participant in the study globally.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    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: 46
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 7
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 39
    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: 288
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 317
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Participants aged ≥ 12 to < 60 months.
    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 651
    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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