protocolSection identificationModule nctId: NCT06374394, orgStudyIdInfo id: 217848, secondaryIdInfos id: 2023-510196-59-00, type: OTHER, domain: EU CTR Number, briefTitle: A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2024-12-03, completionDateStruct date: 2025-05-20, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above., conditionsModule conditions: Respiratory Syncytial Virus Infections, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: Click here to enter text., enrollmentInfo count: 850, type: ESTIMATED, armsInterventionsModule interventions name: RSVPreF3 OA investigational vaccine, interventions name: COVID-19 mRNA vaccine, outcomesModule primaryOutcomes measure: RSV-A neutralization titers, primaryOutcomes measure: RSV-B neutralization titers, primaryOutcomes measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein, secondaryOutcomes measure: RSV-A neutralization titers expressed as GMT, secondaryOutcomes measure: RSV-A neutralization titers expressed as Mean Geometric Increase (MGI), secondaryOutcomes measure: RSV-A neutralization titers expressed as Seroresponse Rate (SRR), secondaryOutcomes measure: Percentage of participants having RSV-A neutralizing titers >= assay cut-off value, secondaryOutcomes measure: RSV-B neutralization titers expressed as GMT, secondaryOutcomes measure: RSV-B neutralization titers expressed as MGI, secondaryOutcomes measure: RSV-B neutralization titers expressed as SRR, secondaryOutcomes measure: Percentage of participants having RSV-B neutralizing titers >= assay cut-off value, secondaryOutcomes measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the pseudovirus bearing S protein expressed as GMT, secondaryOutcomes measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the the pseudovirus bearing S protein expressed as MGI, secondaryOutcomes measure: Percentage of participants having SARS-CoV-2 Omicron XBB.1.5 neutralization titers >= assay cut-off value, secondaryOutcomes measure: Percentage of participants reporting each solicited administration site event, secondaryOutcomes measure: Percentage of participants reporting each solicited systemic event, secondaryOutcomes measure: Percentage of participants reporting unsolicited adverse events (AEs), secondaryOutcomes measure: Percentage of participants reporting serious adverse events (SAEs), secondaryOutcomes measure: Percentage of participants reporting potential immune-mediated diseases (pIMDs), eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GSK Investigational Site, city: Coral Gables, state: Florida, zip: 33134, 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: Jeffrey B. Rosen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.72149, lon: -80.26838, locations facility: GSK Investigational Site, city: Savannah, state: Georgia, zip: 31406, 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: Paul Bradley, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.08354, lon: -81.09983, locations facility: GSK Investigational Site, city: Evansville, state: Indiana, zip: 47714, 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: Hubert Sulit Reyes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.97476, lon: -87.55585, locations facility: GSK Investigational Site, city: Omaha, state: Nebraska, zip: 68134, 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: Brandon James Essink, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.25626, lon: -95.94043, locations facility: GSK Investigational Site, city: Secaucus, state: New Jersey, zip: 07094, 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: Johnathan Blizzard, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.78955, lon: -74.05653, 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: Patrick Connors, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.15478, lon: -77.61556, locations facility: GSK Investigational Site, city: Winston-Salem, state: North Carolina, zip: 27103, 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 Paul Wilson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.09986, lon: -80.24422, locations facility: GSK Investigational Site, city: North Charleston, state: South Carolina, zip: 29405, 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: Kelly Morales, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.85462, lon: -79.97481, locations facility: GSK Investigational Site, city: Newport News, state: Virginia, zip: 23606, 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: George H Freeman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.08339, lon: -76.46965, locations facility: GSK Investigational Site, city: Antwerpen, zip: 2000, country: Belgium, 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: Yven Van Herrewege, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.21989, lon: 4.40346, locations facility: GSK Investigational Site, city: Edegem, zip: 2650, country: Belgium, 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: Nikita Hanning, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.15662, lon: 4.44504, locations facility: GSK Investigational Site, city: Gent, zip: 9000, country: Belgium, 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: Isabel Leroux-Roels, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05, lon: 3.71667, locations facility: GSK Investigational Site, city: Kluisbergen, zip: 9690, country: Belgium, 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: Klaas Vercruysse, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, city: Mechelen, zip: 2800, country: Belgium, 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: Claudia Cornelis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.02574, lon: 4.47762, locations facility: GSK Investigational Site, city: Breda, zip: 4818 CK, country: Netherlands, 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: Simone van der Sar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.58656, lon: 4.77596, locations facility: GSK Investigational Site, city: Enschede, zip: 7512 KZ, country: Netherlands, 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: Paolo Zocca, role: PRINCIPAL_INVESTIGATOR, 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del Monte, state: Madrid, zip: 28660, country: Spain, 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: Silvina Laura Natalini, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.405, lon: -3.87835, locations facility: GSK Investigational Site, city: Barcelona, zip: 08023, country: Spain, 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: Fernando Cereto Castro, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: GSK Investigational Site, city: Barcelona, zip: 08907, country: Spain, contacts name: US GSK Clinical Trials 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email: GSKClinicalSupportHD@gsk.com, contacts name: Jenry Borda Olivas, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.47353, lon: -3.87182, hasResults: False