nctId: NCT06382311 id: 221824 briefTitle: A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults overallStatus: RECRUITING date: 2024-04-18 date: 2024-08-21 date: 2025-05-21 date: 2024-04-24 date: 2024-04-24 name: GlaxoSmithKline class: INDUSTRY briefSummary: The aim of this study is to evaluate the safety, reactogenicity and immunogenicity of the Flu Pandemic messenger RNA (mRNA) vaccine (including dose-finding and dose-confirmation) administered healthy adults 18 to 85 years of age. conditions: Influenza, Human studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Data will be collected in an observer-blind manner in Phase 1 and Phase 2. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1080 type: ESTIMATED name: Flu Pandemic mRNA_Dose level 1 name: Flu Pandemic mRNA_Dose level 2 name: Flu Pandemic mRNA_ Dose level 3. name: Flu Pandemic mRNA_ Dose level 4 name: Flu Pandemic mRNA_Dose level 5 name: Flu Pandemic mRNA_Dose level 6 name: Flu Pandemic mRNA_Dose level 7 name: Placebo measure: Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A] measure: Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A] measure: Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A] measure: Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A] measure: Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A] measure: Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A] measure: Percentage of participants with medically attended adverse events (MAAEs) [Phase 1 and Phase 2 Part A] measure: Percentage of participants with serious adverse events (SAEs) [Phase 1 and Phase 2 Part A] measure: Percentage of participants with adverse events of special interest (AESIs) [Phase 1 and Phase 2 Part A] measure: Phase 1: Percentage of participants with increased in FDA toxicity grading for hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8 measure: Phase 1: Percentage of participants with increased in FDA toxicity grading in hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 29 measure: Phase 1: Percentage of participants with increased in haematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8 measure: Phase 1: Percentage of participants with increased in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 29 measure: Percentage of participants with anti- hemagglutinin inhibition (HI) titers >= 1:40 at Day 43 [Phase 1 and Phase 2 Part A] measure: Percentage of participants with solicited administration site events [Phase 2 Part B] measure: Percentage of participants with solicited systemic events [Phase 2 Part B] measure: Percentage of participants with unsolicited AEs [Phase 2 Part B] measure: Percentage of participants with MAAEs [Phase 2 Part B] measure: Percentage of participants with SAEs [Phase 2 Part B] measure: Percentage of participants with AESIs [Phase 2 Part B] measure: Percentage of participants with increased in FDA toxicity grading for hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8 [Phase 2 Part B] measure: Percentage of participants with increased in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8 [Phase 2 Part B] measure: Percentage of participants with anti-HI titers >= 1:40 at Day 22 [Phase 2 Part B] measure: Geometric mean titers (GMTs) of HA antibody titers [Phase 1 and Phase 2 Part A] measure: Geometric mean increase (GMI) of HA antibody titers [Phase 1 and Phase 2 Part A] measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Percentage of participants with HA antibody Seroconversion rate (SCR) [Phase 1 and Phase 2 Part A] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Percentage of participants with anti-HI antibody titers >= 1:40 [Phase 1 and Phase 2 Part A] measure: Percentage of seropositive participants for the HA antibody titers [Phase 1 and Phase 2 Part A] measure: GMT of Anti-HI antibody titers [Phase 2 Part B] measure: GMI of anti-HI antibody titers [Phase 2 Part B] measure: GMI of anti-HI antibody titers [Phase 2 Part B] measure: GMI of anti-HI antibody titers [Phase 2 Part B] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B] measure: Percentage of participants with anti-HI antibody >= 1:40 [Phase 2 Part B] measure: Percentage of participants with seropositivity of anti-HI antibody titers [Phase 2 Part B] sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Anniston state: Alabama zip: 36207 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: Almena L Free role: PRINCIPAL_INVESTIGATOR lat: 33.65983 lon: -85.83163 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Little Rock state: Arkansas zip: 72204 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: Derek Lewis role: PRINCIPAL_INVESTIGATOR lat: 34.74648 lon: -92.28959 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Fort Collins state: Colorado zip: 80525 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: Michael Thakor role: PRINCIPAL_INVESTIGATOR lat: 40.58526 lon: -105.08442 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Fort Myers state: Florida zip: 33912 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: Pedro P Ylisastigui role: PRINCIPAL_INVESTIGATOR lat: 26.62168 lon: -81.84059 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: West Palm Beach state: Florida zip: 33409 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: Mira Baron role: PRINCIPAL_INVESTIGATOR lat: 26.71534 lon: -80.05337 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Chamblee state: Georgia zip: 30341 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: Adebowale Akintayo role: PRINCIPAL_INVESTIGATOR lat: 33.89205 lon: -84.29881 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: El Dorado state: Kansas zip: 67042 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: Michael Rausch role: PRINCIPAL_INVESTIGATOR lat: 37.81724 lon: -96.86225 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Lenexa state: Kansas zip: 66219 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: Carlos A Fierro role: PRINCIPAL_INVESTIGATOR lat: 38.95362 lon: -94.73357 facility: GSK Investigational Site status: NOT_YET_RECRUITING 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 status: NOT_YET_RECRUITING city: Kansas City state: Missouri zip: 64114 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: Martha Sue Fanning role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Omaha state: Nebraska zip: 68144 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: Tamara Doehner role: PRINCIPAL_INVESTIGATOR lat: 41.25626 lon: -95.94043 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89102 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: Raj Singh role: PRINCIPAL_INVESTIGATOR lat: 36.17497 lon: -115.13722 facility: GSK Investigational Site status: NOT_YET_RECRUITING 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 status: NOT_YET_RECRUITING city: Greensboro state: North Carolina zip: 27408 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: Alexander Vance Murray role: PRINCIPAL_INVESTIGATOR lat: 36.07264 lon: -79.79198 facility: GSK Investigational Site status: NOT_YET_RECRUITING 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: Robert Dean Rosen role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Edmond state: Oklahoma zip: 73013 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: Kyle Rickner role: PRINCIPAL_INVESTIGATOR lat: 35.65283 lon: -97.4781 facility: GSK Investigational Site status: RECRUITING city: Yukon state: Oklahoma zip: 73099 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: Robert J. Lockwood role: PRINCIPAL_INVESTIGATOR lat: 35.50672 lon: -97.76254 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19111 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: Max Mercado role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: GSK Investigational Site status: RECRUITING city: Austin state: Texas zip: 78705 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: Laurence Chu role: PRINCIPAL_INVESTIGATOR lat: 30.26715 lon: -97.74306 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Norfolk state: Virginia zip: 23502 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: Mary Bailey role: PRINCIPAL_INVESTIGATOR lat: 36.84681 lon: -76.28522 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Seattle state: Washington zip: 98015 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: Ashley Fuller role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False