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    Summary
    EudraCT Number:2020-000753-28
    Sponsor's Protocol Code Number:212494
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-05-02
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2020-000753-28
    A.3Full title of the trial
    A Phase 3, randomized, placebo-controlled, observer-blind, multi-country study to demonstrate the efficacy of a single dose and annual revaccination doses of GSK’s RSVPreF3 OA investigational vaccine in adults aged 60 years and above.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy study of GSK’s 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-006
    A.4.1Sponsor's protocol code number212494
    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
    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
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    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 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 nameHigh dose RSVPreF3/adjuvanted
    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 INNconfidential commercial information
    D.3.9.3Other descriptive nameGSKVx000000017064
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number30 to 120
    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
    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
    Respiratory Syncytial Virus Infection
    E.1.1.1Medical condition in easily understood language
    Respiratory syncytial virus infection is caused by RSV, which causes respiratory tract infections in people of all ages.
    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
    •Demonstrate the efficacy of a single dose of the RSVPreF3 OA vaccine in preventing RSV-confirmed LRTD during the first season in adults ≥60 YOA.
    E.2.2Secondary objectives of the trial
    • Demonstrate efficacy of RSVPreF3 OA vaccine following a single and annual revaccination doses in preventing:
    - RSV-confirmed LRTD over several seasons & for each RSV subtype
    - LRTD caused by other respiratory pathogens over 3 seasons
    •Evaluate efficacy of RSVPreF3 OA vaccine after 1 dose and annual revaccination doses in preventing:
    -RSV-confirmed LRTD by age, season, year, baseline comorbidities & frailty status, & for each RSV subtype, severity, RSV-confirmed ARI, LRTD caused by other respiratory pathogens; hospitalization due to respiratory diseases; complications related to RSV-confirmed ARI & any ARI during RSV seasons; Any ARI & any LRTD
    •Evolution of efficacy of single dose of study vaccine in preventing RSV-confirmed LRTD
    •Impact of the study vaccine after 1 dose and annual revaccination doses on LRT symptoms, ARI total symptoms, health utility score, physical functioning
    •Describe RSV-confirmed ARI & LRTD cases
    •Humoral immune response, reactogenicity & safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •A male or female ≥ 60 YOA at the time of the first vaccination, who live in the general community (community dwelling participants) or in a long-term care facility (LTCF) (LTCF participants).
    •Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
    Note: In case of physical incapacity that would preclude the self-completion of the diary cards and/or questionnaires, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant’s health status while answering diaries and/or questionnaires or make decisions on behalf of the participant
    •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. Participants 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 (no laboratory testing required).
    •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
    •Hypersensitivity to latex.
    •Serious or unstable chronic illness.
    •Any history of dementia or any medical condition that moderately or severely impairs cognition.
    Note: If deemed necessary for clinical evaluation, the investigator can use tools such as Mini-Mental State Exam (MMSE), Mini-Cog or Montreal Cognitive Assessment (MoCA) to determine cognition levels of the participant.
    •Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active 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.
    Prior/Concomitant therapy
    •Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the first dose of study vaccine administration, 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 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 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 study vaccine administration 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 (drug or medical device).
    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 participating in the trial until 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.
    •Planned leave or holiday of 4 consecutive weeks or more during the RSV seasons* covered by the study, that would prohibit the reporting of ARI cases and attendance to ARI visit.
    *RSV seasons are from October to April in NH and from March to September in SH.
    E.5 End points
    E.5.1Primary end point(s)
    Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD during the first season following a single dose of the RSVPreF3 OA vaccine in adults ≥ 60 YOA
    E.5.1.1Timepoint(s) of evaluation of this end point
    From 2 weeks post-first vaccination until the efficacy data lock point for analysis, triggered by at least 56 cases accrued (assessed approximately over 7 to 10 months)
    E.5.2Secondary end point(s)
    *Number (No.) of participants with 1st episode of RT-PCR confirmed
    1)*RSV A &/or B associated LRTD over several seasons**
    2)*RSV A &/or B associated LRTD over several seasons***
    3)*RSV subtype A&B LRTD over 3 seasons**
    4)*RSV subtype A&B LRTD over 3 seasons***
    5)*LRTD caused by other respiratory pathogens over 3 seasons**
    6)*LRTD caused by other respiratory pathogens over 3 seasons***
    7)*RSV subtype A&B LRTD****
    8)*LRTD caused by other respiratory pathogens****
    9)*RSV A &/or B associated LRTD, by age categories****
    10)*RSV A &/or B associated LRTD by RSV season****
    11)*RSV A &/or B associated LRTD by year****
    12)*RSV A &/or B associated LRTD**
    13)*RSV A &/or B associated LRTD by baseline comorbidities****
    14)*RSV A &/or B associated LRTD by baseline frailty status****
    15)*RSV A &/or B associated severe LRTD****
    16)*RSV A &/or B associated ARI****
    17)No. of participants with 1st episode of any ARI or any LRTD****
    18)No. of hospitalizations due to respiratory diseases or due to a complication related to respiratory diseases, during the RSV seasons****
    19)No. of hospitalizations due to RSV-confirmed respiratory diseases or due to complication related to RSV-confirmed respiratory diseases, during the RSV seasons****
    20)No. of complications related to ARI & RSV-confirmed ARI during the RSV seasons****
    21)Maximum Influenza Patient- Reported Outcome (Flu-PRO) Chest score for the participants with RT-PCR-confirmed RSV A &/or B-associated ARI****
    22)Least Square Mean Flu-PRO total score for the participants with RT-PCR-confirmed RSV A &/or B-associated ARI****
    23)EuroQol 5-dimension health questionnaire (EQ-5D) utility score for participants with RT-PCR-confirmed RSV A &/or B-associated ARI****
    24)Short Form-12 (SF-12) physical functioning score for participants with RT-PCR confirmed RSV A &/or B-associated ARI****
    25)Duration of RT-PCR confirmed RSV A &/or B ARI & LRTD episodes
    26)No. of participants with each reported symptom/sign of RT-PCR confirmed RSV A &/or B ARI & LRTD episodes
    27)No. of participants with RT-PCR confirmed RSV A &/or B ARI & LRTD episodes according to severity
    28)RSVPreF3 specific immunoglobulin G(IgG) antibody concentrations
    29)RSV A neutralizing antibody titers
    30)RSV B neutralizing antibody titers
    31)No. of participants with any, grade 3 solicited administration site events
    32)No. of participants with any, grade 3 solicited systemic events
    33)No. of days with solicited administrative site & systemic events
    34)No. of participants with any unsolicited AEs
    35)No. of participants with Serious Adverse Events (SAEs)
    36)No. of participants with potential Immune Mediated Diseases (pIMDs)
    37)No. of participants with related SAEs & fatal SAEs
    38)No. of participants with related pIMDs
    **following a single dose of the RSVPreF3 OA vaccine
    ***following annual revaccination (revacc.) doses of the RSVPreF3 OA vaccine
    ****following a single dose of the RSVPreF3 OA vaccine & following annual revacc. doses

    Timeframes:
    1)2 weeks (wks) post 1st vacc. over several seasons (*****)
    2)2 wks post each revacc. dose over several seasons (*****)
    3,5)2 wks post 1st vacc. over 3 seasons (*****)
    4,6)2 wks post each revacc. dose over 3 seasons (*****)
    7)2 wks post 1st & each revacc. dose to the 1st occurrence of LRTD caused by RSV A&B subtype (*****)
    8)2 wks post 1st & each revacc. dose to the 1st occurrence of LRTD caused by other respiratory pathogens (*****)
    9,13,14,15)2 wks post 1st & each revacc. dose to the 1st occurrence of RSV LRTD (*****)
    10)start of the RSV season to the 1st occurrence of RSV-confirmed LRTD at each RSV season (assessed approximately over 7 months at each season)
    11)2 wks post 1st & each revacc. dose until end of year 1, 2&3
    12)2 wks post 1st vacc. to 1st occurrence of RSV LRTD over time (*****)
    16)2 wks post 1st & each revacc. dose to 1st occurrence of RSV ARI (*****)
    17)2 wks post 1st & each revacc. dose to the 1st occurrence of any ARI or any LRTD (*****)
    18,19,20)During the 3 RSV seasons in NH & at least 2 RSV seasons in SH (approximately 7 months for each season)
    21,22)During the 1st 7 days from the onset of ARI symptoms
    23, 24)At the ARI visit (assessed from 2 wks post 1st & each revacc. dose until end of study- ******)
    25,26,27)Assessed during the study period (******)
    28,29,30)At Day 1, Day 31, pre-season 2&3
    31,32,33)During the 4-day follow up period after each vacc. (*******)
    34)During the 30-day follow up period after each vacc. (*******)
    35,36)From the day of the vacc. up to 6 months after each vacc. (*******)
    37,38)From Day 1 up to study end (******)
    *****assessed approximately over 3 years in NH & 2.5-3 years in SH
    ******approximately 3 years in NH & 2.5-3 years in SH
    *******vaccine or placebo administered on Day 1, pre-season 2&3-only applicable for participants in NH
    E.5.2.1Timepoint(s) of evaluation of this end point
    Due to the character limitation, timeframes for secondary endpoints are added after the endpoints in section E.5.2
    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 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
    Immunogenicity
    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 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
    Observer-blind
    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 trial13
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA109
    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
    Canada
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Russian Federation
    South Africa
    United States
    Belgium
    Estonia
    Finland
    Hungary
    Poland
    United Kingdom
    Spain
    Czechia
    Germany
    Italy
    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
    End of Study (EoS): Release of the last testing results of samples collected at the last ARI visit. In these cases, EoS must be achieved no later than 8 months after Last Participant Last Visit (Visit 7NH/Visit 5SH).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days6
    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: 7500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17500
    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 state720
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8728
    F.4.2.2In the whole clinical trial 25000
    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 post-trial treatment provided, participant will continue with standard care.
    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 Opinion2022-06-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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