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    Summary
    EudraCT Number:2022-000099-20
    Sponsor's Protocol Code Number:VAS00006
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-29
    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 ConcernedGermany - PEI
    A.2EudraCT number2022-000099-20
    A.3Full title of the trial
    A Phase IIIb randomized open-label study of nirsevimab (versus no intervention) in preventing hospitalizations due to respiratory syncytial virus in infants (HARMONIE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of a single intramuscular dose of nirsevimab in the prevention of hospitalizations due to respiratory syncytial virus (RSV) infection in healthy term and preterm infants during the first year of life
    A.3.2Name or abbreviated title of the trial where available
    HARMONIE
    A.4.1Sponsor's protocol code numberVAS00006
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1272-2514
    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 SponsorSanofi Pasteur
    B.1.3.4CountryFrance
    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 supportSanofi Pasteur
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Deutschland GmbH
    B.5.2Functional name of contact point
    B.5.3.4CountryGermany
    B.5.6E-mailmedinfo.de@sanofi.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 nameNirsevimab
    D.3.2Product code MEDI8897
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation Yes
    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 INNNIRSEVIMAB
    D.3.9.1CAS number 1989556-22-0
    D.3.9.2Current sponsor code526
    D.3.9.4EV Substance CodeSUB193117
    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) No
    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 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 nameNirsevimab
    D.3.2Product code MEDI8897
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation Yes
    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 INNNIRSEVIMAB
    D.3.9.1CAS number 1989556-22-0
    D.3.9.2Current sponsor code526
    D.3.9.4EV Substance CodeSUB193117
    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) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    respiratory syncytial virus (RSV) infection
    E.1.1.1Medical condition in easily understood language
    respiratory syncytial virus (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 assess the efficacy of nirsevimab in preventing RSV LRTI hospitalization compared to no intervention
    E.2.2Secondary objectives of the trial
    • Assess efficacy of nirsevimab in preventing very severe RSV LRTI and
    hospitalizations for all cause LRTI
    • Assess efficacy of nirsevimab in preventing RSV LRTI hospitalization in
    each country
    • Assess efficacy of nirsevimab in preventing RSV LRTI, very severe RSV
    LRTI and hospitalizations for all-cause LRTI hospitalization through 150
    days post-dosing/randomization
    • Further characterize the safety profile of nirsevimab
    • Assess efficacy of nirsevimab in preventing RSV LRTI hospitalization
    and hospitalizations for allcause LRTI through 180 days
    postdosing/randomization
    • Assess incidence of RSV LRTI hospitalization and hospitalizations for
    all-cause LRTI from 181 days post- dosing/randomization until D366
    • Describe in each study group incidence of RSV LRTI hospitalization and
    all-cause LRTI hospitalization in UK reconsented participants from D366
    to D731
    • Assess incidence of recurrent wheeze in UK reconsented participants
    from D01 to D731
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Born at ≥ 29 weeks gestational age and aged 0 to 12 months (calendar age) who are entering their first RSV season on the day of inclusion in the study (D01)
    - Informed consent form has been signed and dated by the parent(s) or other LAR(s) (and by an independent witness if required by local regulations)
    - Participant and parent/LAR are able to attend the scheduled visit and to comply with all study procedures
    E.4Principal exclusion criteria
    Participants are not eligible for the study if any of the following criteria are met:
    - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

    - Active confirmed RSV infection at the time of dosing/randomization

    - Active LRTI at the time of dosing/randomization

    - Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances

    - Laboratory confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent/LAR, contraindicating intramuscular injection

    - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection

    - Any condition that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion

    - Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided

    - Mother of the infant participant was administered an RSV vaccine during her pregnancy with the infant participant

    - Receipt of any monoclonal antibody by the infant participant

    - Receipt of immune globulins, blood or blood-derived products in the past 3 months by the infant participant

    - Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure

    - Eligible to receive palivizumab at time of inclusion (as per local guidelines)

    - In an emergency setting or hospitalized involuntarily

    - Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
    E.5 End points
    E.5.1Primary end point(s)
    Overall incidence of RSV LRTI hospitalization through the RSV season: Number of RSV LRTI hospitalization through the RSV season.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 180 days post-dosing/randomization
    E.5.2Secondary end point(s)
    1/ Incidence of very severe RSV LRTI through the RSV season: Number of very severe RSV LRTI through the RSV season. Severe RSV LRTI are defined as confirmed RSV hospitalization for LRTI with an oxygen saturation (SaO2) < 90% (at any time) and oxygen supplementation.

    2/ Incidence of hospitalization for LRTI through the RSV season in each country: Number of RSV LRTI hospitalization in each country through the RSV season.

    3/ Overall hospitalization for all cause LRTI in all 3 countries combined throughout the RSV season: Number of RSV LRTI hospitalization in all 3 countries combined through the RSV season.

    4/ Incidence (overall and in each country) of RSV LRTI hospitalization throughout 150 days post-dosing/randomization: Number of RSV LRTI hospitalization, overall and in each country, throughout 150 days post-dosing/randomization.

    5/ Incidence of very severe RSV LRTI in all 3 countries combined through 150 days post-dosing/randomization: Number of very severe RSV LRTI in all 3 countries combined through 151 days post-dosing/randomization. Severe RSV LRTI are defined as confirmed RSV hospitalization for LRTI with an oxygen saturation (SaO2) < 90% (at any time) and oxygen supplementation.

    6/ Incidence of hospitalizations for all cause LRTI through 150 days
    post-dosing/randomization
    7/ Incidence of RSV LRTI hospitalization throughout the second year
    post-immunization/randomization
    8/Incidence of hospitalizations for all-cause LRTI throughout the second
    year post immunization/randomization
    9/ Any immediate adverse events (AEs) reported in the 30.minutes after
    immunization
    10/ Non-serious AEs from D01 (post-dosing/randomization) to D31
    11/ Adverse events of special interest (AESIs) from D01 visit through 1-
    year post-dosing/randomization or D366
    12/ Medically attended adverse events (MAAEs) from D01 visit through
    1-year post-dosing/randomization or D366
    13/ Serious adverse events (SAEs) from D01 visit through 1-year post
    dosing/randomization or D366
    14/ Related SAEs from D366 to D731 for United Kingdom (UK) participants
    15/ Incidence of RSV LRTI hospitalizations through 180 days post
    dosing/randomization (overall and in each country)
    16/ Incidence of hospitalizations for all cause LRTI through 180 days
    post-dosing/randomization
    17/ Incidence of RSV LRTI hospitalization from 181 days post
    dosing/randomization until D366 the end of the study (overall and in
    each country)
    18/ Incidence of hospitalizations for all cause LRTI from 181 days post
    dosing/randomization until D366
    19/Incidence of recurrent wheeze in UK reconsented participants from
    D01 to D731
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/ to 3/: Up to 180 days post-dosing/randomization

    4/, 5/, 6/: Day 151

    7/, 8/, 14/ : Day 366 to Day 731
    9/ : 30 minutes after immunization
    10/ : Day 01 to Day 31
    11/, 12/, 13/ : Day 01 through 1-year post-dosing/randomization (Day
    366)
    15/, 16/ : Day 01 through 180 days post-dosing/randomization
    17/, 18/ : 181 days post-dosing/randomization until Day 366
    19/ : Day 01 to Day 731
    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 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 Yes
    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
    In-person visit at D01, 12-month call for all, 18 and 24-month call for UK reconsented participants.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    1 arm is with no treatment
    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 concerned49
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA300
    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
    United Kingdom
    France
    Germany
    E.8.7Trial has a data monitoring committee No
    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
    LPLV (phone call)
    participant is considered to have completed the study if the parents or
    legally acceptable representatives (LARs) have completed the last
    contact planned in the schedule of activities (SoA) (telephone contact
    at D366 for France, and Germany and UK non reconsented participants
    and telephone contact at D731 for UK reconsented participants). The
    end of the study is defined as the date of the last contact of the last
    participant in the study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 28860
    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: 900
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 13000
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 14960
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    paediatric population
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9620
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 19240
    F.4.2.2In the whole clinical trial 28860
    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 Decision2022-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-21
    P. End of Trial
    P.End of Trial StatusOngoing
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