nctId: NCT06291857 id: CIC-E-301 briefTitle: A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine overallStatus: NOT_YET_RECRUITING date: 2024-08-30 date: 2025-03-15 date: 2025-04-09 date: 2024-03-04 date: 2024-03-20 name: Novavax class: INDUSTRY 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. conditions: COVID-19 studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 4000 type: ESTIMATED name: CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant name: Novavax COVID-19 Vaccine name: Comparator Influenza Vaccine - Fluarix name: Comparator Influenza Vaccine -Fluarix High Dose name: Placebo 0.9% sodium chloride for injection measure: Safety- Solicited AEs over 7 days post-vaccination, For both local injection site symptoms/signs and systemic symptoms/signs measure: Safety-Unsolicited AEs over 21 days post-vaccination and medically attended adverse events (MAAEs). 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 measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMT measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMFR measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as SCR measure: Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMTR measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMT measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMFR measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as SCR measure: Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMTR measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMT measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMFR measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as SCR measure: SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMTR sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False