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    Summary
    EudraCT Number:2019-004680-51
    Sponsor's Protocol Code Number:212496
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-11-27
    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 ConcernedFinland - Fimea
    A.2EudraCT number2019-004680-51
    A.3Full title of the trial
    A phase 3, randomized, open-label, multi-country study to evaluate the immunogenicity, safety, reactogenicity and persistence of a single dose of the RSVPreF3 OA investigational vaccine and different revaccination schedules in adults aged 60 years and above
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity, safety, reactogenicity and persistence of an investigational respiratory syncytial virus (RSV) vaccine in adults aged 60 years and above.
    A.3.2Name or abbreviated title of the trial where available
    RSV OA=ADJ-004
    A.4.1Sponsor's protocol code number212496
    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 SponsorGlaxoSmithKline Biologicals SA
    B.1.3.4CountryBelgium
    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 supportGlaxoSmithKline Biologicals SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals SA
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l’Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number442089904466
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 Yes
    D.2.1.1.1Trade name Arexvy
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals SA
    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 Powder and suspension for 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 INNNA
    D.3.9.2Current sponsor codeGSKVx000000017064
    D.3.9.3Other descriptive nameRecombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E
    D.3.9.4EV Substance CodeSUB217714
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy volunteers (Active immunization for the prevention of disease caused by RSV in adults aged 60 years or above)
    E.1.1.1Medical condition in easily understood language
    RSV virus leads to mild cold-like symptoms in adults & older children.It can cause severe infection,especially in older adults,infants & adults with heart & lung disease/anyone with weak immune system
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10035732
    E.1.2Term Pneumonia respiratory syncytial viral
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10038718
    E.1.2Term Respiratory syncytial virus bronchiolitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10069811
    E.1.2Term Respiratory syncytial virus bronchitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10035692
    E.1.2Term Pneumonia due to respiratory syncytial virus
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10067384
    E.1.2Term Respiratory syncytial virus pneumonitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10052200
    E.1.2Term Respiratory syncytial virus infection NOS
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066741
    E.1.2Term Respiratory syncytial virus infection recurrent
    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 evaluate the humoral immune response following a 1-dose primary schedule of RSVPreF3 OA investigational vaccine up to 12 months post-Dose 1.
    E.2.2Secondary objectives of the trial
    • To further evaluate the humoral immune response following a 1-dose primary schedule of RSVPreF3 OA investigational vaccine up to 12 months post-Dose 1.
    • To evaluate the humoral immune response following 1 dose of the RSVPreF3 OA investigational vaccine and following revaccination doses, up to study end.
    • To evaluate the cell-mediated immune (CMI) response following 1 dose of the RSVPreF3 OA investigational vaccine and following revaccination doses up to study end.
    • To evaluate the safety and reactogenicity of each vaccination schedule of the RSVPreF3 OA investigational vaccine in all participants.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female participants ≥60 YOA at first vaccination, who live in the community (CD participants) or in a Long-term care facility (LTCF participants).
    • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
    • Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure.
    • Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Patients with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.
    E.4Principal exclusion criteria
    Medical conditions
    • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
    • Hypersensitivity to latex.
    • Serious or unstable chronic illness.
    • Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.
    • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
    • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
    • Any history of dementia or any medical condition that moderately or severely impairs cognition.
    Prior/Concomitant therapy
    • Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or planned use during the study period.
    • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated, split virion and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination.
    • Previous vaccination with an RSV vaccine.
    • Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
    • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine or planned administration during the study period.
    • Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine dose or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
    Prior/Concurrent clinical study experience
    • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.
    Other exclusions
    • History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
    • Bedridden participants.
    • Planned move during the study period that will prohibit participation in the trial until the study end. This includes:
    • Planned move during the study period to another LTCF that will prohibit participation in the trial until study end.
    • Planned move from the community to a LTCF that will prohibit participation in the trial until study end.
    • Participation of any study personnel or their immediate dependants, family, or household members.
    E.5 End points
    E.5.1Primary end point(s)
    1, 2, 3, 4. Humoral immune response in terms of RSV-A neutralizing antibody Geometric Mean Titers (GMTs)
    5, 6, 7, 8. Humoral immune response in terms of RSV-B neutralizing antibody titers
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 5. At Day 1 (pre-vaccination)
    2, 6. At Day 31
    3, 7. At Month 6
    4, 8. At Month 12
    E.5.2Secondary end point(s)
    1, 2, 3, 4. Humoral immune response in terms of RSVPreF3-binding Immunoglobulin G (IgG) antibody geometric mean concentrations (GMCs)
    5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16. Humoral immune response in terms of RSV-A neutralizing antibody GMTs
    17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28. Humoral immune response in terms of RSV-B neutralizing antibody titers
    29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40. Humoral immune response in terms of RSVPreF3 IgG antibody GMCs
    41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56. CMI response in terms of frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ and/or CD8+ T cells expressing at least 2 activation markers
    57, 58, 59, 60, 61. Number of participants with at least one solicited administration-site event and solicited systemic event
    62, 63, 64, 65, 66. Number of participants with any unsolicited adverse events (AEs)
    67, 68, 69, 70, 71. Number of participants with serious adverse events (SAEs)
    72, 73, 74, 75, 76. Number of participants reporting any potential immune-mediated disease (pIMD)
    77. Number of participants with a fatal SAE, related SAE and related pIMDs

    Timeframes:
    1, 41. At Day 1 (pre-vaccination)
    2, 42. At Day 31
    3, 43. At Month 6
    4, 44. At Month 12
    5, 17, 29, 45. At Month 18
    6, 18, 30, 46. At Month 24
    7, 19, 31, 47. At Month 30
    8, 20, 32, 48. At Month 36
    9, 21, 33, 49. At Month 42
    10, 22, 34, 50. At Month 48
    11, 23, 35, 51. At Month 54
    12, 24, 36, 52. At Month 60
    13, 25, 37, 53. At Month 13
    14, 26, 38, 54. At Month 25
    15, 27, 39, 55. At Month 37
    16, 28, 40, 56. At Month 49
    57. During the 4 days (including the day of vaccination) following vaccination at Day 1
    58. During the 4 days (including the day of vaccination) following vaccination at Month 12
    59. During the 4 days (including the day of vaccination) following vaccination at Month 24
    60. During the 4 days (including the day of vaccination) following vaccination at Month 36
    61. During the 4 days (including the day of vaccination) following vaccination at Month 48
    62. During the 30 days (including the day of vaccination) following vaccination at Day 1
    63. During the 30 days (including the day of vaccination) following vaccination at Month 12
    64. During the 30 days (including the day of vaccination) following vaccination at Month 24
    65. During the 30 days (including the day of vaccination) following vaccination at Month 36
    66. During the 30 days (including the day of vaccination) following vaccination at Month 48
    67, 72. From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6)
    68, 73. From revaccination (Month 12) up to 6 months post-revaccination (Month 18)
    69, 74. From revaccination (Month 24) up to 6 months post-revaccination (Month 30)
    70, 75. From revaccination (Month 36) up to 6 months post-revaccination (Month 42)
    71, 76. From revaccination (Month 48) up to 6 months post-revaccination (Month 54)
    77. From first vaccination (Day 1) up to study end (Month 60)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Due to character limitations, the timeframes of the secondary endpoints were added in section E.5.2, after the endpoints.
    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
    Immunogenicity
    Reactogenicity
    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 No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 EEA18
    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
    Taiwan
    Japan
    United States
    Finland
    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
    End of Study (EoS): Last testing results released of samples collected at Month 60, i.e. Last Subject Last Visit (LSLV). In these cases, EoS must be achieved no later than 8 months after LSLV.
    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 months3
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days11
    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: 330
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 1320
    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 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 state350
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 727
    F.4.2.2In the whole clinical trial 1653
    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)
    No plan for treatment or care after the subject has ended the participation in this trial is provided for prophylactic vaccine studies as the subjects are healthy and do not need any treatment or care after end of the study.
    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 Decision2021-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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