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    Summary
    EudraCT Number:2020-006051-17
    Sponsor's Protocol Code Number:mRNA-1647-P301
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-11-09
    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 ConcernedFinland - Fimea
    A.2EudraCT number2020-006051-17
    A.3Full title of the trial
    A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluating the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
    A.4.1Sponsor's protocol code numbermRNA-1647-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 pointVice President
    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.5.4Telephone number1617543-6603
    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-1647
    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 INNsee D.3.9.3 'Other descriptive name' below
    D.3.9.2Current sponsor codeCX-000667
    D.3.9.3Other descriptive namemRNA encoding Human cytomegalovirus glycoprotein B
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number62
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsee D.3.9.3 'Other descriptive name' below
    D.3.9.2Current sponsor codeCX-000359
    D.3.9.3Other descriptive namemRNA encoding Human cytomegalovirus UL128
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsee D.3.9.3 'Other descriptive name' below
    D.3.9.2Current sponsor codeCX-005128
    D.3.9.3Other descriptive namemRNA encoding Human cytomegalovirus UL131A
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsee D.3.9.3 'Other descriptive name' below
    D.3.9.2Current sponsor codeCX-000712
    D.3.9.3Other descriptive namemRNA encoding Human cytomegalovirus UL130
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsee D.3.9.3 'Other descriptive name' below
    D.3.9.2Current sponsor codeCX-005282
    D.3.9.3Other descriptive namemRNA encoding Human cytomegalovirus glycoprotein H
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number53
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsee D.3.9.3 'Other descriptive name' below
    D.3.9.2Current sponsor codeCX-000594
    D.3.9.3Other descriptive namemRNA encoding Human cytomegalovirus glycoprotein L
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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
    Prevention of Cytomegalovirus infection
    E.1.1.1Medical condition in easily understood language
    Prevention of Cytomegalovirus 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 10072247
    E.1.2Term Cytomegalovirus immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    * To demonstrate the efficacy of mRNA-1647 vaccine to prevent primary CMV infection in CMV-seronegative female participants
    * To evaluate the safety and reactogenicity of mRNA-1647 vaccine when administered on a 3-dose injection schedule in all participants.
    E.2.2Secondary objectives of the trial
    * To evaluate immunogenicity to mRNA-1647 when administered on a 3-dose injection schedule in all participants.
    * To evaluate persistence of immunogenicity to mRNA-1647 through 24 months after the third injection in all participants.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    "A Substudy of Infant Outcomes in Participants who Become Pregnant During Participation in mRNA-1647-P301."
    mRNA-1647-P301a Substudy is included in the Protocol.
    The aim of the substudy is to assess cytomegalovirus (CMV)-related outcomes in live births of female participants who become pregnant during the course of the mRNA-1647-P301 main study. All objectives and endpoints in this substudy are exploratory.
    E.3Principal inclusion criteria
    Inclusion Criteria
    Participants are eligible to be included in the study only if all the following criteria apply (no protocol exemptions will be allowed in this study):
    1. Is a female and 16 to 40 years of age, at the time of consent.
    2. According to the assessment of the Investigator, is capable of complying with study procedures.
    3. For female participants aged ≥ 20 years, has or anticipates having direct exposure within 7 months after planned first dose (in the home, socially, or occupationally) to at least 1 child ≤ 5 years of age. Direct exposure is defined as either a) participant is the parent, or b) participant has close contact (feeding, diaper changes, childcare/supervision) for at least 8 hours per week.
    4. For the CMV-seronegative Cohorts: at the Screening visit, is CMV IgG-negative and CMV immunoglobulin M (IgM)-negative; For CMV-seropositive Cohorts: at the Screening visit, is CMV IgG-positive and CMV IgMnegative, or CMV IgG-positive and CMV IgM-positive . Participants with an isolated positive result for CMV IgM (ie, CMV IgG-negative and CMV IgM-positive) will not be eligible for enrollment but may be rescreened after at least 6 weeks from the initial CMV screening. A participant with a CMV IgG-positive result and an IgM-indeterminate result at Screening will not require the IgM sampling to be repeated in order to consider the participant CMV-seropositive (Section 5.3).
    5. Participants (and parent/LAR, if applicable) provides written informed consent/assent.
    Participants under the age of majority (ie, under legal age) at the time of enrollment must provide written informed consent at the next study visit once turning the age of majority.
    6. Investigator assessment confirms that the participant (including in the case of an emancipated minor), or parent(s)/LAR(s), as applicable, understands and is willing and physically able to comply with protocol-mandated follow-up including all study visits and procedures anticipated during the 30-month study period.
    7. This criterion has been removed in Protocol Amendment 2: Has a body mass index of 15-35 kg/m2, inclusive.
    8. Female participants of childbearing potential: Urine pregnancy test is negative at Screening and negative on the day of the first injection (Day 1). Note: urine pregnancy test at Screening or Day 1 is not required for female participants of nonchildbearing potential. See Section 11.8 for definition of nonchildbearing potential.
    9. Female participants of childbearing potential: If the participant is sexually active with men, all of the following criteria must be met:
    • 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).
    • Agrees to continue adequate contraception through 3 months following the third study injection (Month 9/Day 257).
    Adequate contraception is defined as consistent and correct use of an approved contraceptive method in accordance with the product label, or sterilization of a monogamous male partner prior to study enrollment (Section 11.8.2).
    E.4Principal exclusion criteria
    Exclusion Criteria
    Participants eligible for the study must not meet any of the following criteria:
    1. This criterion has been removed in Protocol Amendment 2: Female participants: Is of nonchildbearing potential. Nonchildbearing potential is defined as one of the following:
    • Surgically sterile (reports history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy).
    • Postmenopausal state (reports history of amenorrhea for ≥ 12 consecutive months prior to Screening without an alternative medical cause).
    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. This includes but is not limited to:
    • Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, or immune-mediated disease.
    • Dermatologic conditions that could affect local solicited AR assessments (eg, tattoos; psoriasis patches affecting skin over the deltoid areas).
    • Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of the mRNA-1647 vaccine or any components of the mRNA-1647 vaccine.
    • Reported history of bleeding disorder that is considered a contraindication to intramusculary (IM) injection or phlebotomy.
    • 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.
    3. Received or plans to receive any non study vaccine < 28 days prior to and after any study injection; in addition, the following criteria for COVID-19 and influenza vaccines apply:
    - Any COVID-19 primary vaccination series must have been completed a minimum of 28 days prior to receiving any dose of the study injection.
    - COVID-19 vaccines (including any booster dose, regardless of manufacturer) must be administered at least 28 days prior to or after any study injection.
    - Influenza vaccines may be administered > 14 days prior to or after any study injection.
    4. Received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to the day of first injection (Day 1) (for corticosteroids, ≥ 5 mg/day of prednisone equivalent) or plans to do so during the course of the study. Inhaled, nasal, and topical steroids are allowed. Stable immunomodulator regimens used for managing environmental allergies are allowed.
    5. Receipt of an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) < 2 weeks prior to the day of first injection or plans to do so during the course of the study.
    6. Previous receipt of an investigational CMV vaccine.
    7. Receipt of systemic immunoglobulins or blood products < 3 months prior to the day of first injection.
    8. Has donated ≥ 450 mL of blood products < 28 days prior to Screening.
    9. Participated in an interventional clinical study < 28 days prior to the day of first injection (Day 1) or plans to do so while enrolled in this study.
    10. Is a member of study team or is an immediate family member or household member of study personnel.
    E.5 End points
    E.5.1Primary end point(s)
    1. Primary CMV infection, defined as seroconversion from a negative to a positive result
    for serum IgG as measured by a platform-based automated immunoassay based on at least 1 of the 4 recombinant CMV antigens not encoded by mRNA-1647 (pp150, pp28, pp52, pp38) assessed starting 28 days after the third injection.
    2. Solicited ARs through 7 days after each injection, unsolicited AEs through 28 days after each injection, MAAEs from Day 1 through 6 months after the last injection, AESIs from Day 1 through EOS, and SAEs from time of consent through EOS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Screening, Day 1, Day 57/M2, Day 85/M3, Day 169/M6, Day 197/M7, Day 287/M10,
    Day 347/M12, Day 437/M15, Day 527/M18, Day 617/M21, Day 707/M24, Day 797/M27,
    Day 887/M30 (EOS)
    Additional unscheduled study visits will be done if participants report symptoms in between scheduled study visits.
    2. Solicited ARs through 7 days after each injection; Unsolicited AEs through 28 days after each injection, MAAEs from Day 1 through 6 months after the last injection, AESIs from Day 1 through EOS, and SAEs from time of consent through EOS; SAEs from time of consent through EOS. AEs leading to withdrawal/study discontinuation – from Day 1 through EOS.
    E.5.2Secondary end point(s)
    * Antigen-specific nAb and binding antibody GMTs or GMCs on Day 1, Month 3, Month 7, and Month 12.
    * Antigen-specific nAb and binding antibody GMTs or GMCs on Month 18, Month 24, and Month 30.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 1, Day 85/M3, Day 197/M7 and Day 347/M12
    2. Day 527/M18, Day 707/M24, and Day 887/M30 (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
    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 No
    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
    Observer-Blind
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Australia
    Canada
    Israel
    Japan
    United Kingdom
    United States
    Belgium
    Estonia
    Finland
    France
    Germany
    Italy
    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 years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 400
    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: 400
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6500
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    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 state675
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1500
    F.4.2.2In the whole clinical trial 6900
    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)
    Not applicable for a vaccine/prophylaxis study
    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 Decision2021-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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