INFLUENZA VIRUS B/AUSTRIA/1359417/2021 - LIKE STRAIN; INFLUENZA VIRUS A/VICTORIA/4897/2022 (H1N1)PDM09 - LIKE STRAIN; INFLUENZA VIRUS A/THAILAND/8/2022 (H3N2)-LIKE STRAIN for Influenza

Inclusion criteria

• {"criterion_text":"-Age ≥ 20-40 years"}
• {"criterion_text":"-Participants who have not received any influenza as per medical history and documented in DDV (electronic vaccine registry)"}

Exclusion criteria

• {"criterion_text":"-Laboratory-confirmed influenza infection during the past year documented by a positive PCR test in the Danish Microbiological database"}
• {"criterion_text":"-Total IgG levels < 6.1 g/L obtaining at screening visit"}
• {"criterion_text":"-Influenza specific IgA in upper quartile in mucosa. Upper quartile will be defined “real time” in the screening population"}
• {"criterion_text":"-Active smoker"}
• {"criterion_text":"-BMI >35"}
• {"criterion_text":"-Charlson (score > 0)"}
• {"criterion_text":"-Women of childbearing potential not using safe contraception, or who are pregnant, or breast-feeding"}
• {"criterion_text":"-Any allergies to components of or contraindication for Vaxigriptetra® or Flumist®"}
• {"criterion_text":"-Participants who have experienced severe adverse reactions to previous influenza vaccinations or components of the vaccines, including allergy to egg"}
• {"criterion_text":"-Use of immunosuppressive drugs within the past 6 months or who are currently using them"}
• {"criterion_text":"-Known immunodeficiency disorders [any diagnosis that would qualify to an ICD-10 diagnosis in the categories DD80-DD89 (except DD86)"}
• {"criterion_text":"-HIV, HBV, HCV laboatory confirm active infection at screening visit"}
• {"criterion_text":"-Have an acute illness, including an oral temperature ≥ 38°C, within 3 days prior to vaccination"}
• {"criterion_text":"-Have received any vaccines, including live-attenuated vaccines within 4 weeks before inclusion, or plan receipt of such vaccines within 30 days following the inclusion"}
• {"criterion_text":"-Any known malignant neoplasm within 5 years (except basal carcinoma of the skin)"}
• {"criterion_text":"-Severe mental illness or linguistic issues which significantly impedes cooperation"}
• {"criterion_text":"-Inability to provide written informed consent"}
• {"criterion_text":"-Previous medical history, evidence of an intercurrent illness or any condition that, in the opinion of the investigator, would interfere with evaluation of the study vaccine products or interpretation of subject safety or that may compromise the safety of the subject in the study."}

Primary endpoints

• {"endpoint_text":"-Cellular: Antigen activated CD4+ T-lymphocytes measured at –14, day +7 day +28 [+/-5 days]and day +90 [+/-5 days] after vaccination.","definition_or_measurement_approach":"Measurement of antigen-activated CD4+ T-lymphocytes at timepoints –14, day +7, day +28 (±5 days) and day +90 (±5 days) after vaccination."}
• {"endpoint_text":"-Humoral: Number of participants with ≥-4-fold rise in mucosal antibody titer against each vaccine virus haemagglutinin antigens vaccine-specific antibody (IgG and IgA) titers in respiratory secretions measured using antibody titer measured at –14, day +7 day +28 [+/-5 days]and day +90 [+/-5 days] after vaccination","definition_or_measurement_approach":"Number of participants with ≥4-fold rise in mucosal vaccine-specific IgG and IgA antibody titers in respiratory secretions measured at –14, day +7, day +28 (±5 days) and day +90 (±5 days) after vaccination."}

Secondary endpoints

• {"endpoint_text":"-Cellular: Quantification and characterization of leukocyte cell subsets, incl T- and B-cell subsets and activation patterns, using highly standardized flowcytometry in combination with single cell RNAsequencing (scRNAseq) analysis coupled with single cell surface marker profiling (CITEseq or similar platform) for in-depth characterization of immune cell subsets measured at –14, day +7 day +28 [+/-5 days]and day +90 [+/-5 days] after vaccination","definition_or_measurement_approach":"Quantification and characterization of leukocyte subsets (T-, B-cells, activation) using standardized flow cytometry combined with single cell RNA sequencing and single-cell surface marker profiling (e.g., CITE-seq) at –14, day +7, day +28 (±5 days) and day +90 (±5 days)."}
• {"endpoint_text":"-Humoral: Number of participants with ≥-4-fold rise in serum antibody titers against each vaccine virus haemagglutinin antigens vaccine-specific antibody (IgG) titers in serum measured using antibody titer measured measured at –14, day +7 day +28 [+/-5 days]and day +90 [+/-5 days] after vaccination.","definition_or_measurement_approach":"Number of participants with ≥4-fold rise in serum vaccine-specific IgG antibody titers measured at –14, day +7, day +28 (±5 days) and day +90 (±5 days) after vaccination."}

Denmark

Earliest CTIS Part Ii Submission Date

12-01-2024

Latest Decision Or Authorization Date

27-11-2025

Processing Time Days

685

Number Of Sites

1

Number Of Participants

55

Primary sponsor

Full Name

Gentofte Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}