nctId: NCT06389487 id: 222253 id: 2023-510190-34-00 type: OTHER domain: EU CTR Number briefTitle: A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2024-08-12 date: 2025-04-28 date: 2024-04-29 date: 2024-04-29 name: GlaxoSmithKline class: INDUSTRY briefSummary: The aim of this study is to demonstrate the immune response and to evaluate safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for respiratory syncytial virus (RSV) disease, compared to older adults (OA) (\>=) 60 YOA and above conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 850 type: ESTIMATED name: RSVPreF3 OA investigational vaccine measure: RSV-A neutralizing titers expressed as Geometric Mean Titers (GMTs) ratio (RSV-OA over RSV-A-AIR) measure: Seroresponse rate (SRR) in RSV-A neutralizing titers measure: RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR) measure: SRR in RSV-B neutralizing titers measure: Percentage of participants reporting solicited administration site events measure: Percentage of participants reporting solicited systemic events measure: Percentage of participants reporting unsolicited adverse events (AEs) measure: Percentage of participants reporting any serious adverse events (SAEs), related SAEs and fatal SAEs measure: Percentage of participants reporting any adverse events of special interest (AESIs), including potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF) measure: RSV-A neutralizing titers expressed as GMTs measure: RSV-B neutralizing titers expressed as GMTs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Phoenix state: Arizona zip: 85023 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Abram Burgher role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: GSK Investigational Site city: Tempe state: Arizona zip: 85284 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Joseph Daniel Davis role: PRINCIPAL_INVESTIGATOR lat: 33.41477 lon: -111.90931 facility: GSK Investigational Site city: North Hollywood state: California zip: 91606-3287 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Aaron Weinberg role: PRINCIPAL_INVESTIGATOR lat: 34.17223 lon: -118.37897 facility: GSK Investigational Site city: Oakland state: California zip: 94610 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Allison Boyd role: PRINCIPAL_INVESTIGATOR lat: 37.80437 lon: -122.2708 facility: GSK Investigational Site city: Walnut Creek state: California zip: 94598 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Helen L Stacey role: PRINCIPAL_INVESTIGATOR lat: 37.90631 lon: -122.06496 facility: GSK Investigational Site city: Hialeah state: Florida zip: 33012 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jose Cardona role: PRINCIPAL_INVESTIGATOR lat: 25.8576 lon: -80.27811 facility: GSK Investigational Site city: Miami state: Florida zip: 33173 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jorge Caso role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: GSK Investigational Site city: Orlando state: Florida zip: 32806 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Felipe Suplicy role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 facility: GSK Investigational Site city: Lexington state: Kentucky zip: 40509 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Mark S Adams role: PRINCIPAL_INVESTIGATOR lat: 37.98869 lon: -84.47772 facility: GSK Investigational Site city: Silver Spring state: Maryland zip: 20904 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jonathan Cohen role: PRINCIPAL_INVESTIGATOR lat: 38.99067 lon: -77.02609 facility: GSK Investigational Site city: Rochester state: New York zip: 14609 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Matthew G Davis role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 facility: GSK Investigational Site city: Oklahoma City state: Oklahoma zip: 73111 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Charles Lunn role: PRINCIPAL_INVESTIGATOR lat: 35.46756 lon: -97.51643 facility: GSK Investigational Site city: Knoxville state: Tennessee zip: 37909 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: William Smith role: PRINCIPAL_INVESTIGATOR lat: 35.96064 lon: -83.92074 facility: GSK Investigational Site city: DeSoto state: Texas zip: 75115 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Haresh Boghara role: PRINCIPAL_INVESTIGATOR lat: 32.58986 lon: -96.85695 facility: GSK Investigational Site city: Charlottesville state: Virginia zip: 22911 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: James R Clark role: PRINCIPAL_INVESTIGATOR lat: 38.02931 lon: -78.47668 facility: GSK Investigational Site city: Wenatchee state: Washington zip: 98801 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Anton Grasch role: PRINCIPAL_INVESTIGATOR lat: 47.42346 lon: -120.31035 facility: GSK Investigational Site city: St Leonards state: New South Wales zip: 2065 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Munro Neville role: PRINCIPAL_INVESTIGATOR lat: -33.82344 lon: 151.19836 facility: GSK Investigational Site city: Tarragindi state: Queensland zip: 4121 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Ferdinandus de Looze role: PRINCIPAL_INVESTIGATOR lat: -27.53333 lon: 153.03333 facility: GSK Investigational Site city: North Melbourne state: Victoria zip: 3051 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Michelle Giles role: PRINCIPAL_INVESTIGATOR lat: -37.80132 lon: 144.95822 facility: GSK Investigational Site city: St Albans state: Victoria zip: 3021 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Roy Rasalam role: PRINCIPAL_INVESTIGATOR lat: -37.73901 lon: 144.80024 facility: GSK Investigational Site city: New Westminster state: British Columbia zip: V3L 3W4 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: David Shu role: PRINCIPAL_INVESTIGATOR lat: 49.20678 lon: -122.91092 facility: GSK Investigational Site city: Victoria state: British Columbia zip: V8V 4A1 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Michael B Jones role: PRINCIPAL_INVESTIGATOR lat: 48.43294 lon: -123.3693 facility: GSK Investigational Site city: Truro state: Nova Scotia zip: B2N 1L2 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Murdo Ferguson role: PRINCIPAL_INVESTIGATOR lat: 45.36685 lon: -63.26538 facility: GSK Investigational Site city: Guelph state: Ontario zip: N1G 0B4 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Anthony Bier role: PRINCIPAL_INVESTIGATOR lat: 43.54594 lon: -80.25599 facility: GSK Investigational Site city: London state: Ontario zip: N5W 6A2 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Peter Dzongowski role: PRINCIPAL_INVESTIGATOR lat: 42.98339 lon: -81.23304 facility: GSK Investigational Site city: Sherbrooke state: Quebec zip: J1J 2G2 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jean-Sebastien Gauthier role: PRINCIPAL_INVESTIGATOR lat: 45.40008 lon: -71.89908 facility: GSK Investigational Site city: St-Charles-Borromée state: Quebec zip: J6E 2B4 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Bonavuth Pek role: PRINCIPAL_INVESTIGATOR lat: 46.05007 lon: -73.46586 facility: GSK Investigational Site city: Quebec zip: G1N 4V3 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jean-Francois Roussy role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 facility: GSK Investigational Site city: Québec zip: G1V 4G2 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Marie-Louise Vachon role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 facility: GSK Investigational Site city: Weinheim state: Baden-Wuerttemberg zip: 69469 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Beate Moeckesch role: PRINCIPAL_INVESTIGATOR lat: 49.54887 lon: 8.66697 facility: GSK Investigational Site city: Wallerfing state: Bayern zip: 94574 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Josef Grosskopf role: PRINCIPAL_INVESTIGATOR lat: 48.68416 lon: 12.88035 facility: GSK Investigational Site city: Wuerzburg state: Bayern zip: 97074 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Tino F Schwarz role: PRINCIPAL_INVESTIGATOR lat: 49.79391 lon: 9.95121 facility: GSK Investigational Site city: Essen state: Nordrhein-Westfalen zip: 45355 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Axel Schaefer role: PRINCIPAL_INVESTIGATOR lat: 51.45657 lon: 7.01228 facility: GSK Investigational Site city: Witten state: Nordrhein-Westfalen zip: 58455 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Thomas Horacek role: PRINCIPAL_INVESTIGATOR lat: 51.44362 lon: 7.35258 facility: GSK Investigational Site city: Mainz state: Rheinland-Pfalz zip: 55116 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Bernhard Schmitt role: PRINCIPAL_INVESTIGATOR lat: 49.98419 lon: 8.2791 facility: GSK Investigational Site city: Berlin zip: 10117 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Sameer Kulkarni role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: GSK Investigational Site city: Berlin zip: 10787 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Keikawus Arasteh role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: GSK Investigational Site city: Berlin zip: 13347 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Nicole Toursarkissian role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: GSK Investigational Site city: Ibaraki zip: 300-0062 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Kota Yamada role: PRINCIPAL_INVESTIGATOR lat: 34.81641 lon: 135.56828 facility: GSK Investigational Site city: Kanagawa zip: 211-0041 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Masamitsu Takahashi role: PRINCIPAL_INVESTIGATOR lat: 37.58333 lon: 139.91667 facility: GSK Investigational Site city: Tokyo zip: 155-0031 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Tomofumi Murakami role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Tokyo zip: 180-0022 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Minoru Nozaki role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Boksburg state: Gauteng zip: 1459 country: South Africa name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Agatha C Wilhase role: PRINCIPAL_INVESTIGATOR lat: -26.21197 lon: 28.25958 facility: GSK Investigational Site city: Bellville zip: 7530 country: South Africa name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Maria M Pretorius role: PRINCIPAL_INVESTIGATOR lat: -33.90022 lon: 18.62847 facility: GSK Investigational Site city: Mowbray zip: 7700 country: South Africa name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jonathan Peter role: PRINCIPAL_INVESTIGATOR lat: -33.94802 lon: 18.47333 facility: GSK Investigational Site city: Newton zip: 2113 country: South Africa name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Essack Aziz Mitha role: PRINCIPAL_INVESTIGATOR hasResults: False