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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2017-001345-27
    Sponsor's Protocol Code Number:VAC18194RSV2001
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-04-18
    Trial results View results
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    A. Protocol Information
    A.2EudraCT number2017-001345-27
    A.3Full title of the trial
    A Randomized, Double-blind, Phase 1/2a Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.preF in Adults 18 to 50 Years of Age and RSV-seropositive Toddlers 12 to 24 Months of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2a Study to Assess the Safety, Tolerability and Immunogenicity of Ad26.RSV.preF vaccine in Adults and Toddlers
    A.4.1Sponsor's protocol code numberVAC18194RSV2001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/318/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Vaccines & Prevention B.V.
    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 supportJanssen Vaccines & Prevention B.V.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Research & Development
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 20
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    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 nameAd26.RSV.preF
    D.3.2Product code JNJ-64400141
    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 yet assigned
    D.3.9.2Current sponsor codeJNJ-64400141
    D.3.9.3Other descriptive nameAd26.RSV.preF
    D.3.9.4EV Substance CodeSUB187098
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms/ml billion organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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
    Prophylactic against respiratory syncytial virus (RSV) infection
    E.1.1.1Medical condition in easily understood language
    Preventive against RSV infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    1. To assess the safety and tolerability of an intramuscular regimen of two doses of 1x10e11 viral particles (vp) of Ad26.RSV.preF in adults aged 18 to 50 years.
    2. To assess the safety and tolerability of an intramuscular regimen of two doses of 5x10e10 vp of Ad26.RSV.preF in RSV-seropositive toddlers aged 12 to 24 months.
    E.2.2Secondary objectives of the trial
    To assess the humoral and cellular immune responses as measured by virus neutralization assay, F-protein binding antibodies (pre-F and post-F) and intracellular cytokine staining (ICS; to assess T-helper (Th1/Th2) subtyping).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult subjects:
    - Signed informed consent form (ICF)
    - Aged between ≥18 and ≤50 years old
    - In good health, without significant medical illness, on the basis of physical examination, medical history, and vital signs measurement
    - Healthy on the basis of clinical laboratory tests performed at screening
    -Contraceptive use by men or women consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies.
    - Women of childbearing potential must practise an effective method of contraception.
    - Women of childbearing potential must have a negative pregnancy test at screening and immediately prior to each study vaccine administration
    - Subject must agree not to donate blood from first vaccination until 3 months after the final dose.

    Paediatric subjects:
    - Informed consent form (ICF) signed by parent/ legal guardian
    - Aged between ≥12 months to ≤24 months and who is seropositive for RSV. Note: RSV-seropositive toddlers may be recruited if RSV seropositivity was assessed via RSV EIA or virus neutralization assay in a different study of the sponsor.
    - Born out of normal term pregnancy ≥37 weeks, with a minimum birth weight of 2.5 kg
    - In good health without any significant medical illness on the basis of physical examination, medical history, and vital signs performed at screening
    - Received all routine immunizations appropriate for his or her age according to local guidelines
    - Parent/ local guardian must have access to a consistent means of contact either by telephone contact or email/computer
    E.4Principal exclusion criteria
    Adult subjects:
    - Acute illness or temperature ≥38.0 ºC/100.4 °F within 24 hours prior to the first dose of study vaccine
    - History of an underlying clinically significant acute or chronic medical condition or other unsuitable physical examination findings
    - History of malignancy within 5 years before screening (exceptions defined in the protocol)
    - Major surgery within 12 weeks before dosing, or will not have fully recovered from surgery, or has surgery planned during participation in the study or within 6 months after the last dose of study vaccine
    -Chronic active hepatitis B or hepatitis C infection
    - HIV-1 or HIV-2 infection
    - Psychiatric illness and/or drug or alcohol abuse
    - Received or planning to receive other vaccines during the study (vaccine types and time window defined in the protocol)
    - Participation in other interventional trial/ receipt of other investigational drug or medical device (as defined in the protocol)
    - Known allergy, or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components
    - History of chronic urticaria, eczema or atopic dematitis
    - History of acute polyneuropathy
    - Abnormal function of the immune system
    - Contraindication to intramuscular injections and blood draws
    - Pregnancy (incl. planned pregnancy) or breast-feeding
    - Employee of the investigator or the study site directly involved in the study and family members of either the investigator, study-site employee, or employee of the sponsor
    - Subject who cannot communicate reliably with the investigator
    - Subject at risk of not adhering to the requirements of the study or dosing schedule

    Paediatric subjects:
    - Moderate or severe illness or temperature ≥38.0 ºC/100.4 °F within 24 hours prior to the first dose of study vaccine
    - Weight is below 10th percentile according to World Health Organization (WHO) pediatric growth and weight charts
    - Clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation (as detailed in the protocol)
    - Major congenital anomalies or known cytogenetic disorders
    - Major surgery within the 4 weeks prior to randomization or has planned major surgery through the course of the study
    - Received or planning to receive other vaccines during the study (vaccine types and time window defined in the protocol)
    - Known or suspected immunodeficiency, such as known HIV infection
    - Participation in other interventional trial/ receipt of other investigational drug or medical device (as defined in the protocol)
    - Known allergy to vaccines or vaccine components, or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components
    - History of the following moderate to severe chronic conditions: urticaria, eczema or atopic dematitis
    - History of acute polyneuropathy
    - Chronic or recurrent use of immunomodulators/suppressors, oral or parenteral corticosteroids for at least 5 days within 42 days prior to randomization, or planned during the course of the study
    - History of receipt of blood products or immunoglobulin within 3 months of randomization or receipt of palivizumab/Synagis® at any time prior to randomization
    - Contraindication to intramuscular injections and blood draws
    - Parent/ legal guardian cannot communicate reliably with the investigator
    - Family member of either the investigator, study-site employee, or employee of the sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    1. Solicited local and systemic adverse events (AEs) for 7 days after each vaccination.
    2. Unsolicited AEs for 28 days after each vaccination (ie, from informed consent form [ICF] signature through the following 28 days post-first vaccination, and for subsequent vaccinations from time of vaccination through the following 28 days).
    3. SAEs from ICF signature until the end of the study.

    E.5.1.1Timepoint(s) of evaluation of this end point
    1. For 7 days after each vaccination
    2. For 28 days after each vaccination
    3. From ICF signature until the end of the study
    E.5.2Secondary end point(s)
    Immune Responses:
    The analysis of the immunogenicity of vaccine regimens will include the characterization of humoral as well as cellular responses. The focus of the immunogenicity analysis is on virus neutralizing antibodies (VNAs), F-protein antibodies (pre-F and/or post-F) and Th1/Th2 cytokine profile response.
    A) Humoral Immune Response
    - RSV neutralization A strain; Analysis of RSV A neutralizing antibodies.
    - RSV F-protein enzyme-linked immunosorbent assay (ELISA; pre- and/or post-fusion F antibodies); Analysis of antibodies binding to RSV F protein in post-fusion and pre-fusion form.
    B) Cell-mediated Immune Response
    - Intracellular cytokine staining or cytokine analysis; Analysis of CD4 and CD8 T-cell subsets and their cytokine expression patterns will be determined by flow cytometry after RSV F-protein peptide stimulation (including, but not limited to CD4/CD8, interleukin-2 [IL-2], IFNγ, tumor necrosis factor alpha (TNFα) and Th1/Th2 subtyping).

    E.5.2.1Timepoint(s) of evaluation of this end point
    Pre-vaccination for 1st and 2nd doses and at 28 days post Dose 2 and 6 months post Dose 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 No
    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
    Tolerability, Immunogenicity
    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. trial type description
    Safety, Tolerability and Immunogenicity
    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 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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    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: 36
    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) Yes
    F. of subjects for this age range: 36
    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: 12
    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 Yes
    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. of subjects incapable of giving consent
    Paediatric patients aged between ≥12 months to ≤24 months
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 48
    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)
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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