nctId: NCT06374394 id: 217848 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 overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-12-03 date: 2025-05-20 date: 2024-04-18 date: 2024-04-18 name: GlaxoSmithKline class: INDUSTRY 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. conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE maskingDescription: Click here to enter text. count: 850 type: ESTIMATED name: RSVPreF3 OA investigational vaccine name: COVID-19 mRNA vaccine measure: RSV-A neutralization titers measure: RSV-B neutralization titers measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein measure: RSV-A neutralization titers expressed as GMT measure: RSV-A neutralization titers expressed as Mean Geometric Increase (MGI) measure: RSV-A neutralization titers expressed as Seroresponse Rate (SRR) measure: Percentage of participants having RSV-A neutralizing titers >= assay cut-off value measure: RSV-B neutralization titers expressed as GMT measure: RSV-B neutralization titers expressed as MGI measure: RSV-B neutralization titers expressed as SRR measure: Percentage of participants having RSV-B neutralizing titers >= assay cut-off value measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the pseudovirus bearing S protein expressed as GMT measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the the pseudovirus bearing S protein expressed as MGI measure: Percentage of participants having SARS-CoV-2 Omicron XBB.1.5 neutralization titers >= assay cut-off value measure: Percentage of participants reporting each solicited administration site event measure: Percentage of participants reporting each solicited systemic event measure: Percentage of participants reporting unsolicited adverse events (AEs) measure: Percentage of participants reporting serious adverse events (SAEs) measure: Percentage of participants reporting potential immune-mediated diseases (pIMDs) sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Coral Gables state: Florida zip: 33134 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: Jeffrey B. Rosen role: PRINCIPAL_INVESTIGATOR lat: 25.72149 lon: -80.26838 facility: GSK Investigational Site city: Savannah state: Georgia zip: 31406 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: Paul Bradley role: PRINCIPAL_INVESTIGATOR lat: 32.08354 lon: -81.09983 facility: GSK Investigational Site city: Evansville state: Indiana zip: 47714 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: Hubert Sulit Reyes role: PRINCIPAL_INVESTIGATOR lat: 37.97476 lon: -87.55585 facility: GSK Investigational Site city: Omaha state: Nebraska zip: 68134 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: Brandon James Essink role: PRINCIPAL_INVESTIGATOR lat: 41.25626 lon: -95.94043 facility: GSK Investigational Site city: Secaucus state: New Jersey zip: 07094 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: Johnathan Blizzard role: PRINCIPAL_INVESTIGATOR lat: 40.78955 lon: -74.05653 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: Patrick Connors role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 facility: GSK Investigational Site city: Winston-Salem state: North Carolina zip: 27103 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 Paul Wilson role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 facility: GSK Investigational Site city: North Charleston state: South Carolina zip: 29405 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: Kelly Morales role: PRINCIPAL_INVESTIGATOR lat: 32.85462 lon: -79.97481 facility: GSK Investigational Site city: Newport News state: Virginia zip: 23606 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: George H Freeman role: PRINCIPAL_INVESTIGATOR lat: 37.08339 lon: -76.46965 facility: GSK Investigational Site city: Antwerpen zip: 2000 country: Belgium 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: Yven Van Herrewege role: PRINCIPAL_INVESTIGATOR lat: 51.21989 lon: 4.40346 facility: GSK Investigational Site city: Edegem zip: 2650 country: Belgium 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: Nikita Hanning role: PRINCIPAL_INVESTIGATOR lat: 51.15662 lon: 4.44504 facility: GSK Investigational Site city: Gent zip: 9000 country: Belgium 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: Isabel Leroux-Roels role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: GSK Investigational Site city: Kluisbergen zip: 9690 country: Belgium 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: Klaas Vercruysse role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site city: Mechelen zip: 2800 country: Belgium 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: Claudia Cornelis role: PRINCIPAL_INVESTIGATOR lat: 51.02574 lon: 4.47762 facility: GSK Investigational Site city: Breda zip: 4818 CK country: Netherlands 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: Simone van der Sar role: PRINCIPAL_INVESTIGATOR lat: 51.58656 lon: 4.77596 facility: GSK Investigational Site city: Enschede zip: 7512 KZ country: Netherlands 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: Paolo Zocca role: PRINCIPAL_INVESTIGATOR lat: 52.21833 lon: 6.89583 facility: GSK Investigational Site city: Utrecht zip: 3584 BA country: Netherlands 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: Marc Bonten role: PRINCIPAL_INVESTIGATOR lat: 52.09083 lon: 5.12222 facility: GSK Investigational Site city: Zutphen zip: 7207 AE country: Netherlands 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: Martijn Goosens role: PRINCIPAL_INVESTIGATOR lat: 52.13833 lon: 6.20139 facility: GSK Investigational Site city: Boadilla del Monte state: Madrid zip: 28660 country: Spain 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: Silvina Laura Natalini role: PRINCIPAL_INVESTIGATOR lat: 40.405 lon: -3.87835 facility: GSK Investigational Site city: Barcelona zip: 08023 country: Spain 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: Fernando Cereto Castro role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: GSK Investigational Site city: Barcelona zip: 08907 country: Spain 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: Cristina Masuet Aumatell role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: GSK Investigational Site city: Coruña zip: 15006 country: Spain 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 Jose Pereira Rodriguez role: PRINCIPAL_INVESTIGATOR lat: 43.37135 lon: -8.396 facility: GSK Investigational Site city: Madrid zip: 28040 country: Spain 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: Helena Moza Moríñigo role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site city: Madrid zip: 28041 country: Spain 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: Pablo Rojo Conejo role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site city: Majadahonda zip: 28222 country: Spain 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: Jenry Borda Olivas role: PRINCIPAL_INVESTIGATOR lat: 40.47353 lon: -3.87182 hasResults: False