Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41039   clinical trials with a EudraCT protocol, of which   6717   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-000753-28
    Sponsor's Protocol Code Number:212494
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-04-07
    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 ConcernedGermany - PEI
    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 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.3.10.3Concentration numberconfidential info
    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 the RSVPreF3 OA vaccine in preventing RSV-confirmed LRTD after at least 1 season in adults ≥60 YOA.
    E.2.2Secondary objectives of the trial
    •Demonstrate efficacy of RSVPreF3 OA vaccine in preventing RSV-confirmed LRTD in adults≥60 YOA over several seasons.
    •In adults≥60 YOA, evaluate efficacy of RSVPreF3 OA vaccine in preventing:
    -RSV-confirmed LRTD by age category, by season, by year, by baseline comorbidities, by baseline frailty status & for each RSV subtype (A & B) separately; severe RSV-confirmed LRTD & 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
    •Evolution of efficacy of RSVPreF3 OA vaccine in preventing RSV-confirmed LRTD
    •Impact of RSVPreF3 OA vaccine on lower respiratory tract symptoms,ARI total symptoms,health utility score, physical functioning in RSVPreF3 group compared to placebo
    •Describe RSV-confirmed ARI cases & RSV-confirmed LRTD cases in RSVPreF3 & placebo groups
    •Humoral immune response to RSVPreF3 OA vaccine
    •Reactogenicity & safety of RSVPreF3 OA vaccine
    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 (CD participants) or in a LTCF (LTCF participants).
    •Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards and questionnaires, attend regular phone calls/study site visits, perform self-swabbing, ability to access and utilize a phone or other electronic communications).
    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 (e.g. current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), 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 (e.g. completion of the diary cards and questionnaires, attend regular phone calls/study site visits, perform self-swabbing).
    •Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 3 years).
    •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 (Day -29 to Day 1), 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 and ending 30 days after the 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 the 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 (e.g. infliximab).
    •Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the 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 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)
    First episode of RT-PCR confirmed RSV A and/or B associated LRTD after at least one season in adults ≥ 60 YOA
    E.5.1.1Timepoint(s) of evaluation of this end point
    From 1-month post-vaccination until at least end of 1st RSV season in NH and at least until 56 cases have been accrued.
    E.5.2Secondary end point(s)
    1. First episode of RT-PCR confirmed RSV A and/or B associated LRTD over several seasons [From 1-month post vaccination over several seasons(assessed approximately over 3 years in NH & 2.5-3 years in SH)]
    2. First episode of RT-PCR confirmed RSV subtype A and subtype B LRTD (1-month post vaccination to 1st occurrence of RSV LRTD caused by RSV A & B subtype*)
    3. First episode of RT-PCR confirmed RSV A and /or B associated LRTD, by age categories (1-month post vaccination to 1st occurrence of RSV LRTD*)
    4. First episode of RT-PCR confirmed RSV A and/or B associated LRTD by RSV season [1-month post vaccination to 1st occurrence of RSV-confirmed LRTD at each RSV season (approximately over 7 months)]
    5. First episode of RT-PCR confirmed RSV A and/or B associated LRTD by year (1-month post vaccination until end of year 1, 2 and 3)
    6. First episode of RT-PCR confirmed RSV A and/or B associated LRTD over time (1-month post vaccination to 1st occurrence of RSV LRTD*)
    7. First episode of RT-PCR confirmed RSV A and/or B associated LRTD by baseline comorbidities (1-month post vaccination to 1st occurrence of RSV LRTD*)
    8. First episode of RT-PCR confirmed RSV A and/or B associated LRTD by baseline frailty status (1-month post vaccination to 1st occurrence of RSV LRTD*)
    9. First episode of RT-PCR confirmed RSV A and/or B associated severe LRTD (1-month post vaccination to 1st occurrence of RSV LRTD*)
    10. First episode of RT-PCR confirmed RSV A and/or B associated Acute Respiratory Infection (ARI) (1-month post vaccination to 1st occurrence of RSV ARI*)
    11. First episode of LRTD caused by other respiratory pathogens as confirmed by RT-PCR (1-month post vaccination to 1st occurrence of LRTD*)
    12. Number of hospitalizations due to respiratory diseases or due to a complication related to respiratory diseases, during the RSV seasons (During 3 consecutive RSV seasons in NH & At least 2 consecutive RSV seasons in SH)
    13. Number of hospitalizations due to RSV-confirmed respiratory diseases or due to complication related to RSV-confirmed respiratory diseases, during the RSV seasons (During 3 consecutive RSV seasons in NH & At least 2 consecutive RSV seasons in SH)
    14. Complications related to ARI and RSV-confirmed ARI during the RSV seasons (During 3 consecutive RSV seasons in NH & At least 2 consecutive RSV seasons in SH)
    15. Maximum Influenza Patient- Reported Outcome (Flu-PRO) Chest score for the participants with RT-PCR-confirmed RSV A and/or B-associated ARI (During first 7 days from onset of ARI symptoms)
    16. Least Square Mean Flu-PRO total score for the participants with RT-PCR-confirmed RSV A and/or B-associated ARI (During first 7 days from onset of ARI symptoms)
    17. EuroQol 5-dimension health questionnaire (EQ-5D) utility score for participants with RT-PCR-confirmed RSV A and/or B-associated ARI [At ARI visit(assessed from 1-month post vaccination until study end-approximately 3 years in NH & 2.5-3 years in SH)]
    18. Short Form-12 (SF-12) physical functioning score for participants with RT-PCR confirmed RSV A and/or B-associated ARI [At ARI visit(assessed from 1-month post vaccination until study end-approximately 3 years in NH & 2.5-3 years in SH)]
    19. Duration of RT-PCR confirmed RSV A and/or B ARI and LRTD episodes [(Assessed during study period (NH-approximately 3 years & SH-2.5-3 years)]
    20. Number of each reported symptoms/signs of RT-PCR confirmed RSV A and/or B ARI and LRTD episodes [(Assessed during study period (NH-approximately 3 years & SH-2.5-3 years)]
    21. Number of RT-PCR confirmed RSV A and/or B ARI and LRTD episodes according to severity [(Assessed during study period (NH-approximately 3 years & SH-2.5-3 years)]
    22. RSVPreF3 specific immunoglobulin G(IgG) antibody concentrations (At Day 1, Day 31, pre-season 2 & pre-season 3)
    23. RSV A neutralizing antibody titers (At Day 1, Day 31, pre-season 2 & pre-season 3)
    24. Number of participants with any, grade 3 solicited administration site events (During 4-day follow up period after vaccination)
    25. Number of participants with any, grade 3 solicited systemic events (During 4-day follow up period after vaccination)
    26. Number of days with solicited administrative site and systemic events (During 4-day follow up period after vaccination)
    27. Number of participants with any unsolicited adverse events (AEs) (During 30-day follow up period after vaccination)
    28. Number of participants with Serious Adverse Events (SAEs) (From Day 1 up to 6 months after vaccination)
    29. Number of participants with potential Immune Mediated Diseases (pIMDs) (From Day 1 up to 6 months after vaccination)
    30. Number of participants with related SAEs and fatal SAEs [(From Day 1 up to study end (NH-approximately 3 years & SH-2.5-3 years)]
    31. Number of participants with related pIMDs [(From Day 1 up to study end (NH-approximately 3 years & SH-2.5-3 years)]

    *assessed approximately over 3 years in NH & 2.5-3 years in SH
    E.5.2.1Timepoint(s) of evaluation of this end point
    Due to the character limitation, timeframes for secondary endpoints are added in paranthesis along with the respective 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 trial5
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned28
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA87
    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
    Belgium
    Brazil
    Canada
    Estonia
    Finland
    Germany
    Italy
    Japan
    Korea, Republic of
    Mexico
    Poland
    Russian Federation
    South Africa
    Spain
    United Kingdom
    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
    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 5NH/Visit 4SH).
    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 days0
    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 days0
    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 state2800
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8590
    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 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 Decision2021-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-15
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA