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    Summary
    EudraCT Number:2018-002742-37
    Sponsor's Protocol Code Number:66735.041.18
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-15
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-002742-37
    A.3Full title of the trial
    Effect of intranasal administration of palivizumab on respiratory syncytial virus-associated infection – a randomized controlled trial
    Effect van intranasale toediening van palivizumab op respiratoir syncytieel virus infectie – een gerandomiseerde placebo-gecontroleerd onderzoek
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nasal administration of palivizumab to prevent respiratory syncytial virus infection
    Narsyn: Nasale toediening van palivizumab om RS-virus infectie te voorkomen
    A.3.2Name or abbreviated title of the trial where available
    Narsyn
    A.4.1Sponsor's protocol code number66735.041.18
    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 SponsorUniversity Medical Center Utrecht
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Medical Center Utrecht
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht
    B.5.2Functional name of contact pointNarsyn trial information
    B.5.3 Address:
    B.5.3.1Street AddressLundlaan 6
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584EA
    B.5.3.4CountryNetherlands
    B.5.6E-mailnarsyn@umcutrecht.nl
    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 nameCommercial Synagis
    D.3.4Pharmaceutical form Nasal drops
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    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 placeboNasal drops
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    respiratory syncytial virus infection
    E.1.1.1Medical condition in easily understood language
    respiratory syncytial virus infection
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    Study A: The main objective of this non-commercial trial is self-reported symptoms (local and systemic AE's) according to the FDA scorecard and SAE’s. The phase IIb will be initiated based on the overall safety profile, there must be no treatment SAE or AE's as determined by the investigator and DSMB.
    Study B: The primary objective of this non-commercial trial is RSV infection with lab-confirmed diagnosis.
    E.2.2Secondary objectives of the trial
    Study A: Observation of symptoms by a physician will take place for the 10 minutes following administration on the first day of intervention. We will test nasal swab samples for a respiratory panel to exclude the possibility of respiratory pathogen as the cause of symptoms when symptoms are present.
    Study B: RSV hospitalization*, medically-attended RSV infection, any hospitalization, any non-hospitalized RSV infection, any respiratory disease, non-tested medically attended respiratory tract infection (RTI), RSV negative RTI admission, non-tested RTI admission, use of respiratory medication, otitis media, and wheeze in the first year of life. Incidence and total days of RSV-associated ICU stay, mechanical ventilation and supplemental oxygen. Nasal swabs for co-infections by other respiratory pathogens. Safety data on local and systemic adverse events and severe adverse events.
    *: Key secondary outcome
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Study A
    Adult men and women between the ages of 18 and 60 in good health based on relevant medical history.

    Study B
    Healthy preterm infants with gestational age between 32 and 35 weeks and less than 6 months of age at the onset of the RSV season. Children must have a least one sibling. Only children of parents who master the Dutch language are included.
    E.4Principal exclusion criteria
    Study A
    Adults with a nasal cold or obstructions in the nasal cavity that could interfere with administration of the study vaccine are excluded. History of any respiratory symptoms or clinically significant infectious disease within 4 weeks prior to drug administration or immunocompromised subjects are excluded from the study. Final, nasal surgery prior to or during the trial is an exclusion criterion.

    Study B
    Children with a known cardiac anomaly, Down syndrome or other serious congenital disorders and children who received surfactant treatment are excluded from the study.
    E.5 End points
    E.5.1Primary end point(s)
    Any RSV infection with laboratory-confirmed RSV.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Follow up for RSV infection will occur only during the first RSV season from initiation of treatment through the end of April.
    E.5.2Secondary end point(s)
    RSV hospitalization*, medically-attended RSV infection, any hospitalization, any non-hospitalized RSV infection, any respiratory disease, non-tested medically attended respiratory tract infection (RTI), RSV negative RTI admission, non-tested RTI admission, use of respiratory medication, otitis media, and wheeze in the first year of life. Incidence and total days of RSV-associated ICU stay, mechanical ventilation and supplemental oxygen. Nasal swabs for co-infections by other respiratory pathogens. Safety data on local and systemic adverse events and severe adverse events.
    *: Key secondary outcome
    E.5.2.1Timepoint(s) of evaluation of this end point
    Follow up for RSV hospitalization, medically-attended RSV infection, any hospitalization, any non-hospitalized RSV infection, any respiratory disease, non-tested medically attended respiratory tract infection (RTI), RSV negative RTI admission, non-tested RTI admission, otitis media, and days ICU admission/ mechanical ventilation/supplemental oxygen will occur only during the first RSV season from initiation of treatment through the end of April. Follow-up for wheeze and respiratory medication use will occur through the first year of life.
    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) 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
    Safety
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 No
    E.8.1.6Cross over Yes
    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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 trial will end once the inclusion goal of n=348 has been reached. If the sample size is not reached by the end of the second RSV season a futility analysis will be performed with a conditional power of at least 10% for success to determine whether a third season of enrollement will be performed.
    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 months0
    E.8.9.1In the Member State concerned 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: 408
    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: 408
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 408
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    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 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
    Parents will give consent for their newborns.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state408
    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)
    Plans to continue from phase I to phase IIB and if phase IIB shows efficacy to move to a phase III trial so that the product can be registered so access is guaranteed in the trial population. Otherwise, no special treatment after end of trial participation other than standard medical care is guaranteed.
    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 Decision2018-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-07
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