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    Summary
    EudraCT Number:2020-002405-26
    Sponsor's Protocol Code Number:MK-1654-004
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-10-10
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2020-002405-26
    A.3Full title of the trial
    A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the safety of MK-1654 and how well MK-1654 works in healthy infants.
    A.4.1Sponsor's protocol code numberMK-1654-004
    A.5.4Other Identifiers
    Name:INDNumber:130097
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/486/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Romania SRL
    B.5.2Functional name of contact pointClinical Research Director
    B.5.3 Address:
    B.5.3.1Street AddressBulevardul Poligrafiei, No. 1A, Etaj 5, 1st District
    B.5.3.2Town/ cityBucharest
    B.5.3.3Post code013704
    B.5.3.4CountryRomania
    B.5.4Telephone number+40215292900
    B.5.5Fax number+40212333533
    B.5.6E-mailelena.aldea@merck.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 MK-1654
    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 INNMK-1654
    D.3.9.2Current sponsor codeMK-1654
    D.3.9.3Other descriptive nameMK-1654 (SUB221140)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    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 RSV
    E.1.1.1Medical condition in easily understood language
    Prevention of RSV
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066742
    E.1.2Term Respiratory syncytial virus infection prophylaxis
    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 evaluate the efficacy of MK-1654 compared to placebo as assessed by the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) [outpatient and inpatient] from Days 1 through 150 postdose.
    To evaluate the safety and tolerability of MK-1654 compared to placebo as assessed by the proportion of participants experiencing adverse events (AEs).
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of MK-1654 compared to placebo as assessed by the incidence of RSV-associated hospitalization from Days 1 through 150 postdose
    To estimate the efficacy of MK-1654 compared to placebo as assessed by the incidence of RSV-associated MALRI (outpatient and inpatient) from Days 1 through 180 postdose
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A participant will be eligible for inclusion in the study if the participant:

    1. Is healthy (based on medical history and physical examination results).

    2. Is male or female and is an early or moderate pre-term infant (≥29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (≥35 weeks gestational age).

    3. For the Phase 2b cohort only: Has a chronological age >2 weeks of age up to 1 year and is entering the first RSV season at the time that documented informed consent is provided.

    4. For the Phase 3 cohort only: Has a chronological age from birth up to 1 year and is entering the first RSV season at the time that documented informed consent is provided.

    5. The participant’s legally acceptable representative provides documented informed consent for the study. The participant’s legally acceptable representative may also provide documented consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
    E.4Principal exclusion criteria
    The participant must be excluded from the study if the participant:

    1. Is eligible or recommended to receive palivizumab per national or local (eg, state or provincial) guidelines or professional society recommendations.

    2. Has known hypersensitivity to any component of MK-1654 (refer to the IB for a list of components).

    3. Has a bleeding disorder contraindicating intramuscular administration.

    4. Has had a recent illness with rectal temperature ≥100.5°F (≥38.1°C) or axillarytemperature ≥100.0°F (≥37.8°C) within 72 hours predose.

    5. Has received any vaccine or mAb for the prevention of RSV, including receipt of maternal RSV vaccination during the mother’s pregnancy.

    6. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this current study. Participants enrolled in observational studies may be included and will be reviewed on a case-by-case basis for approval by the Sponsor.

    7. Has enrolled previously in the current study and been discontinued.

    8. Has a parent/legal guardian/legally acceptable representative who is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.

    9. Has any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.

    10. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of participants with RSV-associated MALRI
    2. Percentage of participants with solicited injection-site AEs
    3. Percentage of participants with fever
    4. Percentage of participants with solicited systemic AEs
    5. Percentage of participants with anaphylaxis/hypersensitivity AE of special interest (AESI)
    6. Percentage of participants with rash AESI
    7. Percentage of participants with ≥1 nonserious AE
    8. Percentage of participants with serious adverse events (SAEs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From Day 1 (postdose) to Day 150
    2. From Day 1 (postdose) to Day 5
    3. From Day 1 (postdose) to Day 5
    4. From Day 1 (postdose) to Day 5
    5. From Day 1 (postdose) to Day 42
    6. From Day 1 (postdose) to Day 42
    7. From Day 1 (postdose) to Day 42
    8. Up to Day 515
    E.5.2Secondary end point(s)
    1. Percentage of participants with RSV-associated hospitalization
    2. Percentage of participants with RSV-associated MALRI
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From Day 1 (postdose) to Day 150
    2. From Day 1 (postdose) to Day 180
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 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 EEA84
    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
    Chile
    Colombia
    Malaysia
    Peru
    Philippines
    Brazil
    Canada
    China
    Israel
    Japan
    Korea, Republic of
    Mexico
    South Africa
    Thailand
    United Kingdom
    United States
    Belgium
    Czechia
    Denmark
    Finland
    France
    Germany
    Italy
    Poland
    Romania
    Türkiye
    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
    For the purposes of analysis and reporting, the overall study ends when the Sponsor receives the last laboratory result or the last participant completes the last studyrelated contact, withdraws from the study, or is lost to follow-up (ie, the participant’s legally acceptable representative is unable to be contacted by the investigator), whichever comes last.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 3300
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 220
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 880
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 2200
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1220
    F.4.2.2In the whole clinical trial 3300
    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 Decision2022-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-27
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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