protocolSection identificationModule nctId: NCT06382311, orgStudyIdInfo 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2024-08-21, completionDateStruct date: 2025-05-21, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Influenza, Human, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: PREVENTION, maskingInfo 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, enrollmentInfo count: 1080, type: ESTIMATED, armsInterventionsModule interventions name: Flu Pandemic mRNA_Dose level 1, interventions name: Flu Pandemic mRNA_Dose level 2, interventions name: Flu Pandemic mRNA_ Dose level 3., interventions name: Flu Pandemic mRNA_ Dose level 4, interventions name: Flu Pandemic mRNA_Dose level 5, interventions name: Flu Pandemic mRNA_Dose level 6, interventions name: Flu Pandemic mRNA_Dose level 7, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with medically attended adverse events (MAAEs) [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with serious adverse events (SAEs) [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with adverse events of special interest (AESIs) [Phase 1 and Phase 2 Part A], primaryOutcomes 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, primaryOutcomes 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, primaryOutcomes 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, primaryOutcomes 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, primaryOutcomes measure: Percentage of participants with anti- hemagglutinin inhibition (HI) titers >= 1:40 at Day 43 [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with solicited administration site events [Phase 2 Part B], primaryOutcomes measure: Percentage of participants with solicited systemic events [Phase 2 Part B], primaryOutcomes measure: Percentage of participants with unsolicited AEs [Phase 2 Part B], primaryOutcomes measure: Percentage of participants with MAAEs [Phase 2 Part B], primaryOutcomes measure: Percentage of participants with SAEs [Phase 2 Part B], primaryOutcomes measure: Percentage of participants with AESIs [Phase 2 Part B], primaryOutcomes 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], primaryOutcomes 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], primaryOutcomes measure: Percentage of participants with anti-HI titers >= 1:40 at Day 22 [Phase 2 Part B], secondaryOutcomes measure: Geometric mean titers (GMTs) of HA antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Geometric mean increase (GMI) of HA antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Percentage of participants with HA antibody Seroconversion rate (SCR) [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Percentage of participants with anti-HI antibody titers >= 1:40 [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Percentage of seropositive participants for the HA antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: GMT of Anti-HI antibody titers [Phase 2 Part B], secondaryOutcomes measure: GMI of anti-HI antibody titers [Phase 2 Part B], secondaryOutcomes measure: GMI of anti-HI antibody titers [Phase 2 Part B], secondaryOutcomes measure: GMI of anti-HI antibody titers [Phase 2 Part B], secondaryOutcomes measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B], secondaryOutcomes measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B], secondaryOutcomes measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B], secondaryOutcomes measure: Percentage of participants with anti-HI antibody >= 1:40 [Phase 2 Part B], secondaryOutcomes measure: Percentage of participants with seropositivity of anti-HI antibody titers [Phase 2 Part B], eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Anniston, state: Alabama, zip: 36207, 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: Almena L Free, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.65983, lon: -85.83163, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Little Rock, state: Arkansas, zip: 72204, 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 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name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Raj Singh, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.17497, lon: -115.13722, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, 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, status: NOT_YET_RECRUITING, city: Greensboro, state: North Carolina, zip: 27408, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, 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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: Kyle Rickner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.65283, lon: -97.4781, locations facility: GSK Investigational Site, status: RECRUITING, city: Yukon, state: Oklahoma, zip: 73099, 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: Robert J. 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