protocolSection identificationModule nctId: NCT06291857, orgStudyIdInfo id: CIC-E-301, briefTitle: A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-30, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-04-09, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Novavax, class: INDUSTRY, descriptionModule briefSummary: The goal of this Phase 3 study is to compare the effectiveness, safety, and side effects of the CIC vaccine with approved flu vaccines and the Novavax COVID-19 Vaccine with adjuvant., conditionsModule conditions: COVID-19, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule interventions name: CIC Vaccine Co-formulated tNIV2, SARSCoV-2 rS and Matrix-M Adjuvant, interventions name: Novavax COVID-19 Vaccine, interventions name: Comparator Influenza Vaccine - Fluarix, interventions name: Comparator Influenza Vaccine -Fluarix High Dose, interventions name: Placebo 0.9% sodium chloride for injection, outcomesModule primaryOutcomes measure: Safety- Solicited AEs over 7 days post-vaccination, For both local injection site symptoms/signs and systemic symptoms/signs, primaryOutcomes measure: Safety-Unsolicited AEs over 21 days post-vaccination and medically attended adverse events (MAAEs)., primaryOutcomes measure: Safety-Treatment-related MAAEs, serious adverse events (SAEs), and adverse events of special interest (AESIs) (including potential immune-mediated medical conditions [PIMMCs] and myocarditis and/or pericarditis) over 6 months, secondaryOutcomes measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMT, secondaryOutcomes measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMFR, secondaryOutcomes measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as SCR, secondaryOutcomes measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMTR, secondaryOutcomes measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMT, secondaryOutcomes measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMFR, secondaryOutcomes measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as SCR, secondaryOutcomes measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMTR, secondaryOutcomes measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMT, secondaryOutcomes measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMFR, secondaryOutcomes measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as SCR, secondaryOutcomes measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMTR, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False