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    Summary
    EudraCT Number:2020-005458-97
    Sponsor's Protocol Code Number:VAC18193RSV3001
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-29
    Trial results View 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 ConcernedFinland - Fimea
    A.2EudraCT number2020-005458-97
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RSV Vaccine Phase 3 study for participants age 60 years and older
    A.3.2Name or abbreviated title of the trial where available
    EVERGREEN
    A.4.1Sponsor's protocol code numberVAC18193RSV3001
    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 SponsorJanssen Vaccines & Prevention B.V.
    B.1.3.4CountryNetherlands
    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.4.2CountryNetherlands
    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
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameAd26.RSV.preF-based Vaccine
    D.3.2Product code VAC18193
    D.3.4Pharmaceutical form Suspension 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 codeJNJ-64400141
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeJNJ-64213175
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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 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
    Prevention of Lower Respiratory Tract Disease Caused by The respiratory syncytial virus (RSV)
    E.1.1.1Medical condition in easily understood language
    Prevention of Lower Respiratory Tract Disease Caused by RSV
    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
    The primary objective of this study is to demonstrate efficacy of the Ad26.RSV.preF-based study vaccine in the prevention of RT-PCR-confirmed RSV-mediated LRTD when compared to placebo in adults aged 60 years and above.
    E.2.2Secondary objectives of the trial
    1. To demonstrate the efficacy of active study vaccine in the prevention of any RT-PCR-confirmed RSV mediated acute respiratory infection (ARI) during the first RSV season when compared to placebo.
    2. To demonstrate the efficacy of active study vaccine in the prevention of RT-PCR-confirmed RSV-mediated LRTD during the second year over the whole study when compared to placebo when compared to placebo in adults aged 60 years and
    above
    3. To demonstrate the efficacy of active study vaccine in the prevention of any RT-PCR-confirmed RSV mediated ARI during the second year when compared to placebo
    4. To demonstrate the efficacy of active study vaccine in the prevention of predefined clinically relevant disease associated with RT-PCR confirmed RSV mediated ARI over the whole study when compared to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must be ≥60 years old on the day of signing the ICF and expected to be available for the duration of the study.
    2. Before randomization, a participant must be:
    - postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and
    - not intending to conceive by any methods.
    3. In the investigator’s clinical judgment, the participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, CHF, COPD, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable and medically controlled in the judgement of the investigator at the time of vaccination, and these conditions receive routine follow-up by the participant’s healthcare provider. Participants will be included on the basis of medical history and vital signs taken between ICF signature and vaccination.
    4. From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood.
    E.4Principal exclusion criteria
    1. Has a serious clinically unstable condition, Alzheimer’s disease, or any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant
    2. History of malignancy within 5 years before screening or revaccination not in the following categories:
    a. Participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator.
    b. Participants with a history of malignancy within 5 years, which is considered cured with minimal risk of recurrence per investigator’s judgement, can be enrolled.
    3. Had major surgery (eg, major cardiopulmonary or abdominal operations) as per the investigator’s judgment within 4 weeks before vaccination, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study.
    4. Has abnormal function of the immune system resulting from:
    a. Clinical conditions (eg, autoimmune disease or immunodeficiency) expected to have an impact on the immune response elicited by the study vaccine.
    b. Chronic or recurrent use of systemic corticosteroids within 2 months before administration of study vaccine and during the study. A substantially immunosuppressive steroid dose is considered to be ≥2 weeks of daily receipt of 20 mg of prednisone or equivalent.
    c. Administration of antineoplastic and immunomodulating agents, eg, cancer chemotherapeutic agents, or radiotherapy within 6 months before administration of study vaccine and during the study.
    5. Received or plans to receive:
    a. Licensed live-attenuated vaccines within 28 days before or after planned administration of study vaccination
    b. Other licensed (not live) vaccines within 14 days before or after planned administration of study vaccination.
    6. Has an acute illness (including acute respiratory illnesses) or body temperature of ≥38.0ºC (≥100.4ºF) within 24 hours prior to administration of study vaccine.
    7. Has had major psychiatric illness and/or drug or alcohol abuse which in the investigator’s opinion would compromise the participant’s safety and/or compliance with the study procedures.
    8. Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine). Refer to the latest version of the Investigator’s Brochure for Ad26/protein preF RSV vaccine
    9. History of acute polyneuropathy (eg, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy (CIDP).
    10. Received hematopoietic stem cell transplant in medical history, immunoglobulins in the 2 months, immunoglobulins specific to RSV, hMPV, or parainfluenza viruses in the 12 months, apheresis therapies in the 4 months, or blood products in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study.
    11. Received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the study vaccine or is currently enrolled or plans to participate in another investigational study during this study.
    12. Contraindication to IM injections and blood draws (eg, bleeding disorders).
    13. Received an RSV vaccine in a previous RSV vaccine study.
    14. For participants in the Safety Subset only: Participants who have significant scarring, tattoos, abrasions, cuts, or infections over the deltoid region of both arms that, in the investigator’s opinion, could interfere with evaluation of injection site local reactions.
    15. Received or plans to receive a SARS-CoV-2 vaccine:
    a. Live-attenuated SARS-CoV-2 vaccine within 28 days before or after planned administration of the first or subsequent study vaccines.
    b. Non-live SARS-CoV-2 vaccine within 14 days before or after planned administration of the first or subsequent study vaccines.
    c. A viral-vectored SARS-CoV-2 vaccine within 28 days before or after planned administration of the first or subsequent study vaccines.
    16. Received or plans to receive an Ad26-vectored vaccine at any time prior to randomization until 28 days after each study vaccination (this does not apply to SARS-CoV-2 vaccines; please refer to exclusion criterion 19).
    E.5 End points
    E.5.1Primary end point(s)
    First occurrence of RT-PCR-confirmed, RSVmediated LRTD with onset at least 14 days after the first dose of study vaccine
    E.5.1.1Timepoint(s) of evaluation of this end point
    at least 14 days after dosing with study vaccine
    E.5.2Secondary end point(s)
    1. First occurrence of any RT-PCR-confirmed RSV-mediated ARI with onset at least 14 days after dosing of study vaccine
    2. First occurrence of RT-PCR-confirmed RSV mediated LRTD during the second year, with onset after study Day 365
    3. First occurrence of any RT-PCR-confirmed RSV-mediated ARI during the second year, with onset after study Day 365
    4. First occurrence of predefined clinically relevant disease associated with RT-PCR-confirmed RSV-mediated ARI over the whole study with onset at least 14 days after dosing of study vaccine
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 4 - at least 14 days after dosing with study vaccine
    2 and 3 - after study Day 365
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    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 No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Brazil
    Canada
    Chile
    China
    Korea, Republic of
    New Zealand
    South Africa
    Taiwan
    Thailand
    United States
    Estonia
    Finland
    Poland
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) 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: 2414
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24726
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    adults 60 years and over; immunocompromised or with underlying chronic cardiopulmonary conditions
    F.4 Planned number of subjects to be included
    F.4.1In the member state750
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2900
    F.4.2.2In the whole clinical trial 27140
    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 Decision2021-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-07-21
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