protocolSection identificationModule nctId: NCT06389487, orgStudyIdInfo id: 222253, secondaryIdInfos 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2024-08-12, completionDateStruct date: 2025-04-28, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule 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, conditionsModule conditions: Respiratory Syncytial Virus Infections, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 850, type: ESTIMATED, armsInterventionsModule interventions name: RSVPreF3 OA investigational vaccine, outcomesModule primaryOutcomes measure: RSV-A neutralizing titers expressed as Geometric Mean Titers (GMTs) ratio (RSV-OA over RSV-A-AIR), primaryOutcomes measure: Seroresponse rate (SRR) in RSV-A neutralizing titers, primaryOutcomes measure: RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR), primaryOutcomes measure: SRR in RSV-B neutralizing titers, secondaryOutcomes measure: Percentage of participants reporting solicited administration site events, secondaryOutcomes measure: Percentage of participants reporting solicited systemic events, secondaryOutcomes measure: Percentage of participants reporting unsolicited adverse events (AEs), secondaryOutcomes measure: Percentage of participants reporting any serious adverse events (SAEs), related SAEs and fatal SAEs, secondaryOutcomes measure: Percentage of participants reporting any adverse events of special interest (AESIs), including potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF), secondaryOutcomes measure: RSV-A neutralizing titers expressed as GMTs, secondaryOutcomes measure: RSV-B neutralizing titers expressed as GMTs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GSK Investigational Site, city: Phoenix, state: Arizona, zip: 85023, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Abram Burgher, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, locations facility: GSK Investigational Site, city: Tempe, state: Arizona, zip: 85284, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Joseph Daniel Davis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.41477, lon: -111.90931, locations facility: GSK Investigational Site, city: North Hollywood, state: California, zip: 91606-3287, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Aaron Weinberg, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.17223, lon: -118.37897, locations facility: GSK Investigational Site, city: Oakland, state: California, zip: 94610, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Allison Boyd, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.80437, lon: -122.2708, locations facility: GSK Investigational Site, city: Walnut Creek, state: California, zip: 94598, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Helen L Stacey, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.90631, lon: -122.06496, locations facility: GSK Investigational Site, city: Hialeah, state: Florida, zip: 33012, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jose Cardona, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.8576, lon: -80.27811, locations facility: GSK Investigational Site, city: Miami, state: Florida, zip: 33173, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jorge Caso, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: GSK Investigational Site, city: Orlando, state: Florida, zip: 32806, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Felipe Suplicy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.53834, lon: -81.37924, locations facility: GSK Investigational Site, city: Lexington, state: Kentucky, zip: 40509, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Mark S Adams, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98869, lon: -84.47772, locations facility: GSK Investigational Site, city: Silver Spring, state: Maryland, zip: 20904, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jonathan Cohen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.99067, lon: -77.02609, locations facility: GSK Investigational Site, city: Rochester, state: New York, zip: 14609, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Matthew G Davis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.15478, lon: -77.61556, locations facility: GSK Investigational Site, city: Oklahoma City, state: Oklahoma, zip: 73111, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Charles Lunn, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.46756, lon: -97.51643, locations facility: GSK Investigational Site, city: Knoxville, state: Tennessee, zip: 37909, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: William Smith, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.96064, lon: -83.92074, locations facility: GSK Investigational Site, city: DeSoto, state: Texas, zip: 75115, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Haresh Boghara, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.58986, lon: -96.85695, locations facility: GSK Investigational Site, city: Charlottesville, state: Virginia, zip: 22911, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: James R Clark, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.02931, lon: -78.47668, locations facility: GSK Investigational Site, city: Wenatchee, state: Washington, zip: 98801, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Anton Grasch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.42346, lon: -120.31035, locations facility: GSK Investigational Site, city: St Leonards, state: New South Wales, zip: 2065, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Munro Neville, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.82344, lon: 151.19836, locations facility: GSK Investigational Site, city: Tarragindi, state: Queensland, zip: 4121, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Ferdinandus de Looze, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.53333, lon: 153.03333, locations facility: GSK Investigational Site, city: North Melbourne, state: Victoria, zip: 3051, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Michelle Giles, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.80132, lon: 144.95822, locations facility: GSK Investigational Site, city: St Albans, state: Victoria, zip: 3021, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Roy Rasalam, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.73901, lon: 144.80024, locations facility: GSK Investigational Site, city: New Westminster, state: British Columbia, zip: V3L 3W4, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: David Shu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.20678, lon: -122.91092, locations facility: GSK Investigational Site, city: Victoria, state: British Columbia, zip: V8V 4A1, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Michael B Jones, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.43294, lon: -123.3693, locations facility: GSK Investigational Site, city: Truro, state: Nova Scotia, zip: B2N 1L2, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Murdo Ferguson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.36685, lon: -63.26538, locations facility: GSK Investigational Site, city: Guelph, state: Ontario, zip: N1G 0B4, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Anthony Bier, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.54594, lon: -80.25599, locations facility: GSK Investigational Site, city: London, state: Ontario, zip: N5W 6A2, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Peter Dzongowski, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.98339, lon: -81.23304, locations facility: GSK Investigational Site, city: Sherbrooke, state: Quebec, zip: J1J 2G2, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jean-Sebastien Gauthier, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.40008, lon: -71.89908, locations facility: GSK Investigational Site, city: St-Charles-Borromée, state: Quebec, zip: J6E 2B4, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Bonavuth Pek, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.05007, lon: -73.46586, locations facility: GSK Investigational Site, city: Quebec, zip: G1N 4V3, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jean-Francois Roussy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 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city: Wallerfing, state: Bayern, zip: 94574, country: Germany, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Josef Grosskopf, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.68416, lon: 12.88035, locations facility: GSK Investigational Site, city: Wuerzburg, state: Bayern, zip: 97074, country: Germany, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Tino F Schwarz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.79391, lon: 9.95121, locations facility: GSK Investigational Site, city: Essen, state: Nordrhein-Westfalen, zip: 45355, country: Germany, 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