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    Summary
    EudraCT Number:2020-005996-11
    Sponsor's Protocol Code Number:MK-1654-007
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-12-17
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2020-005996-11
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-
    Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
    Multicentrické, randomizované, částečně zaslepené klinické hodnocení fáze 3, kontrolované palivizumabem, jehož cílem je vyhodnotit bezpečnost, účinnost a farmakokinetiku přípravku MK-1654 u kojenců a dětí se zvýšeným rizikem závažného průběhu onemocnění RSV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Palivizumab-Controlled Evaluation of Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
    Palivizumabem kontrolované vyhodnocení bezpečnosti, účinnosti a farmakokinetiky MK-1654 u kojenců a dětí se zvýšeným rizikem závažného průběhu onemocnění RSV
    A.4.1Sponsor's protocol code numberMK-1654-007
    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 LLC
    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 LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme LLC
    B.5.2Functional name of contact pointGlobal Clinical Trial Operations
    B.5.3 Address:
    B.5.3.1Street Address126 East Lincoln Avenue P.O.Box 2000
    B.5.3.2Town/ cityRahway, New Jersey
    B.5.3.3Post code07065
    B.5.3.4CountryUnited States
    B.5.4Telephone number+17325945269
    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 INNNot available
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.1.1Trade name Synagis (Palivizumab)
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNPALIVIZUMAB
    D.3.9.1CAS number 188039-54-5
    D.3.9.3Other descriptive namePALIVIZUMAB
    D.3.9.4EV Substance CodeSUB03606MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 in vial
    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 Respiratory syncytial virus (RSV) infection in infants and children at increased risk for severe RSV disease
    E.1.1.1Medical condition in easily understood language
    Prevention of Respiratory Syncytial Virus (RSV) infection in infants.
    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 LLT
    E.1.2Classification code 10066742
    E.1.2Term Respiratory syncytial virus infection prophylaxis
    E.1.2System Organ Class 100000004865
    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 MK-1654 compared to palivizumab in RSV Season 1 as assessed by the proportion of participants experiencing AEs.
    E.2.2Secondary objectives of the trial
    1. To estimate the efficacy of MK-1654 compared to palivizumab as assessed by the incidence of RSV-associated MALRI (outpatient and inpatient) from Days 1 through 150 post Dose 1 in RSV Season 1.
    2. To estimate the incidence of RSV-associated hospitalizations from Days 1 through 150 post Dose 1 in RSV Season 1 in the MK-1654 and palivizumab groups.
    3. To describe the serum PK concentration of MK-1654 at Days 7, 150, and 240 after the dose of MK-1654 in RSV Season 1.
    4. To describe the safety of MK-1654 administered in RSV Season 2 as assessed by the proportion of participants experiencing AEs.
    5. To describe the serum PK concentration of MK-1654 at Days 7 and 150 postdose in RSV Season 2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations, and meets 1 or more of the following criteria:
    a) Early or Moderate Pre-term Group (excluding participants with CLD or hemodynamically significant CHD): ≤35 weeks, 0 days gestational age.
    b) CLD/CHD Group:
    - CLD Participants: have CLD of prematurity (also known as bronchopulmonary dysplasia), as defined by:
    ● American Academy of Pediatrics [American Academy of Pediatrics Committee on Infectious Diseases 2014]: ≤32 weeks, 0 days gestational age and require medical intervention/management for at least 28 days after birth, or
    ● Other national or local guidelines or professional society recommendations.
    - CHD Participants: have hemodynamically significant CHD, as defined by:
    ● American Academy of Pediatrics [American Academy of Pediatrics
    Committee on Infectious Diseases 2014]: Uncorrected or palliated cyanotic or acyanotic disease associated with documented pulmonary hypertension or a requirement for daily medication to manage congestive heart failure, or as diagnosed by a pediatric cardiologist
    ● other national or local guidelines or professional society recommendations.
    2. Is available to complete the follow-up period:
    - Up to 575 days (180 days after RSV Season 2 dose) for participants eligible for RSV Season 2 dose of MK-1654, or
    - Approximately 365 days after the RSV Season 1 Dose 1 for all other participants.
    3. Is male or female and has a chronological age from birth up to 1 year and is entering their first RSV season at the time informed consent is provided.
    4. 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.

    For Participation in RSV Season 2:
    5. Participants enrolled in the CLD/CHD group as defined in Inclusion Criteria #1b. Participants with CHD are required to meet the following additional criteria:
    - Have hemodynamically significant CHD at the beginning of RSV Season 2, or
    - If the participant has had surgically repaired hemodynamically significant CHD that did not include ECMO or cardiopulmonary bypass:
    ● Continues to require medications to manage CHD, or
    ● Any additional medical intervention related to their CHD
    6. Participants enrolled in the Early or Moderate Pre-term Group as defined in Inclusion Criteria #1a, with the following:
    - Neuromuscular disease or congenital pulmonary anomaly that impairs the ability to clear secretions from the upper airway because of ineffective cough
    - Down Syndrome (trisomy of chromosome 21)
    - Cystic fibrosis with nutritional compromise (eg, weight <10th percentile at time of enrollment)
    - Native Americans and Alaskan Indians or other indigenous populations at high risk for severe RSV disease.
    E.4Principal exclusion criteria
    1. Requires mechanical ventilation at time of enrollment.
    2. Has a life expectancy <6 months.
    3. Has known hepatic or renal dysfunction, or chronic seizure disorder.
    4. Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
    5. Has severe immunodeficiency or is severely immunocompromised, including but not limited to:
    - AIDS (CD4 percentage <25%, or history of AIDS-Defining Condition),
    - leukemia, myeloproliferative disorder, or other malignancy and receiving or expected to receive chemotherapy during the study,
    - status post solid-organ or bone marrow transplantation and on a systemic immunosuppressive regimen,
    OR
    - severe combined immunodeficiency.
    6. Has known hypersensitivity to any component of MK-1654 or palivizumab.
    7. Has received other investigational agents at any time before study entry.
    8. Is anticipated to have either of the following within 60 days after randomization resulting in: 1) surgical correction hemodynamically insignificant CHD, 2) cardiac surgical procedure that will require cardiopulmonary bypass.
    9. Requires ECMO or continuous positive airway pressure at the time of enrollment or anticipated within 60 days after randomization.
    10. Has an anticipated or planned cardiac transplantation to occur during the course of this study.
    11. Has a bleeding disorder contraindicating intramuscular administration.
    12. Has had a recent illness with rectal temperature ≥100.5°F (≥38.1°C) or axillary temperature ≥100.0°F (≥37.8°C) within 72 hours predose.
    13. Has symptoms of LRI within 7 days predose.
    14. Has received any vaccine or mAb for the prevention of RSV, including receipt of maternal RSV vaccination during the mother’s pregnancy.
    15. 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.
    16. Has enrolled previously in the current study and been discontinued.
    17. 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.
    18. Has any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
    19. 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.

    For Participation in RSV Season 2:
    20. Has a life expectancy <6 months.
    21. Has known hepatic or renal dysfunction, or chronic seizure disorder.
    22. Has severe immunodeficiency or is severely immunocompromised, including but not limited to:
    - AIDS (CD4 percentage <25%, or history of AIDS-Defining Condition),
    - leukemia, myeloproliferative disorder, or other malignancy and receiving or expected to receive chemotherapy during the study,
    - status post solid-organ or bone marrow transplantation and on a systemic immunosuppressive regimen,
    OR
    - severe combined immunodeficiency.
    23. Had 1) ECMO or 2) surgical intervention during the RSV season for CHD and required cardiopulmonary bypass during the procedure in RSV Season 1.
    24. Has known hypersensitivity to any component of MK-1654.
    25. Has bleeding disorder contraindicating intramuscular administration.
    26. 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.
    27. Has any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of participants with solicited injection-site Adverse Events (AEs) in respiratory syncytial virus (RSV) Season 1
    2. Percentage of participants with solicited daily body temperature with fever in RSV Season 1
    3. Percentage of participants with solicited systemic AEs in RSV Season 1
    4. Percentage of participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1
    5. Percentage of participants with rash AESI in RSV Season 1
    6. Percentage of participants with non-serious AEs in RSV Season 1
    7. Percentage of participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Days 1 through 5 after each dose in RSV Season 1
    2. Days 1 through 5 after each dose in RSV Season 1
    3. Days 1 through 5 after each dose in RSV Season 1
    4. Days 1 through 28 after Dose 1 and Days 1 through 14 after Dose 2 in RSV Season 1
    5. Days 1 through 28 after Dose 1 and Days 1 through 14 after Dose 2 in RSV Season 1
    6. Days 1 through 28 after Dose 1 and 14 days after each dose in RSV Season 1
    7. Up to 365 days
    E.5.2Secondary end point(s)
    1. Percentage of participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
    2. Percentage of participants with RSV-associated hospitalization in RSV Season 1
    3. Percentage of participants with solicited injection-site AEs in RSV Season 2
    4. Percentage of participants with solicited daily body temperature with fever in RSV Season 2
    5. Percentage of participants with solicited systemic AEs in RSV Season 2
    6. Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 2
    7. Percentage of participants with rash AESI in RSV Season 2
    8. Percentage of participants with non-serious AEs in RSV Season 2
    9. Percentage of participants with SAEs through 180 days postdose in RSV Season 2
    10. Serum concentration of MK-1654 after dose of MK-1654 in RSV Season 1
    11. Serum concentration of MK-1654 after dose of MK-1654 in RSV Season 2
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Days 1 through 150 post Dose 1 in RSV Season 1
    2. Days 1 through 150 post Dose 1 in RSV Season 1
    3. Days 1 through 5 postdose in RSV Season 2
    4. Days 1 through 5 postdose in RSV Season 2
    5. Days 1 through 5 postdose in RSV Season 2
    6. Days 1 through 42 postdose in RSV Season 2
    7. Days 1 through 42 postdose in RSV Season 2
    8. Days 1 through 42 postdose in RSV Season 2
    9. Days 1 through 180 postdose in RSV Season 2
    10. Days 7, 150, and 240 after dose of MK-1654 in RSV Season 1
    11. Days 7 and 150 after dose of MK-1654 in RSV Season 2
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Part 1 - Double-blind. Part 2 - Unblinded, open-label
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA77
    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
    Chile
    Colombia
    Japan
    Malaysia
    Mexico
    New Zealand
    Peru
    Puerto Rico
    Singapore
    South Africa
    Taiwan
    Thailand
    United States
    Finland
    France
    Spain
    Czechia
    Germany
    Greece
    Italy
    Hungary
    Norway
    Russian Federation
    Turkey
    United Kingdom
    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 study-related contact, withdraws from the study, or is lost to follow-up, 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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 1000
    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: 350
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 100
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 550
    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 Yes
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 599
    F.4.2.2In the whole clinical trial 1000
    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 Decision2022-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-29
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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