INFLUENZA VIRUS B/MICHIGAN/01/2021, INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED, INFLUENZA A VIRUS, A/CROATIA/10136RV/2023 (H3N2) LIKE STRAIN X-425A, INACTIVATED for Influenza | Obesity | Type 2 diabetes

Inclusion criteria

• {"criterion_text":"- 1)\tThe subject is able to give their written consent to participate in the trial."}
• {"criterion_text":"- 2)\tFor female subjects of fertile age, adequate contraception should be used (Groups 1, 2 and 3)."}
• {"criterion_text":"- 3)\tObesity as defined by BMI ≥30kg/m2 (Group 1 and Group 4)"}
• {"criterion_text":"- 4)\tAged 18-50 years at inclusion"}
• {"criterion_text":"- 5)\tA diagnosis of diabetes mellitus type 2, or no diagnosis of diabetes mellitus (Groups 2 and 3)"}
• {"criterion_text":"- 6) For group 2 and group 5 non-obese as defined by BMI 18.5-29.9kg/m2 and for group 3 normal body weight as defined by BMI 18.5-24.9kg/m2"}
• {"criterion_text":"- 7) Pregnant after week 12 (Groups 4 and 5)"}

Exclusion criteria

• {"criterion_text":"- Documented receipt of influenza vaccine in the current season September-April."}
• {"criterion_text":"- Confirmed influenza infection during the current season September-April."}
• {"criterion_text":"- Pregnancy prior to week 12."}
• {"criterion_text":"- Unable to give informed consent due to either language barrier or condition affecting the ability of the potential participant to understand, retain or communicate their consent as judged by the study investigator."}
• {"criterion_text":"- Allergy to Vaxigrip."}
• {"criterion_text":"- Confirmed anaphylaxis after exposure to egg or after previous influenza vaccination."}
• {"criterion_text":"- Disease, condition or concomitant medication known to cause immunosuppression."}
• {"criterion_text":"- Current or previous malignancy within the past 5 years (with the exception of CIN I or II cervical pre-cancerous lesions, or skin cancers in situ)."}
• {"criterion_text":"- Receipt of Immunoglobulin within the preceding 6 months."}
• {"criterion_text":"- Receipt of blood transfusion within the preceding 6 months."}
• {"criterion_text":"- Receipt of another vaccine less than 14 days prior to study vaccination in the case of inactivated vaccines or 30 days in the case of live vaccines."}
• {"criterion_text":"- Participation in another clinical trial during the study period."}
• {"criterion_text":"- Planned move during the study period that would prohibit participating in the study for its full duration."}
• {"criterion_text":"- Participation of any study personnel or their immediate dependents, family or household members as well as any family relations to the sponsor or the PI."}
• {"criterion_text":"- Any other pre-existing disease or medical condition judged by the trial investigator as being a contra-indication for study participation."}
• {"criterion_text":"- Antibiotic use in the previous 12 weeks."}

Primary endpoints

• {"endpoint_text":"- Hemaglutinnin Inhibition Assay GMTs at day 0 (pre-vaccination) and at 14 days post-vaccination with Vaxigrip.","definition_or_measurement_approach":"Measured by Hemagglutination Inhibition Assay (HAI); geometric mean titres (GMTs) assessed at day 0 and day 14 post-vaccination."}
• {"endpoint_text":"- The proportion of participants achieving a protective hemagluttinin inhibition assay titre ≥40 at 14 days post-vaccination.","definition_or_measurement_approach":"Proportion of participants with HAI titre ≥40 at 14 days post-vaccination as measured by HAI."}
• {"endpoint_text":"- The proportion of participants achieving a four-fold rise in hemagluttinin inhibition assay titre at 14 days post-vaccination.","definition_or_measurement_approach":"Proportion of participants with a ≥4-fold rise in HAI titre from baseline (day 0) to day 14 post-vaccination."}

Secondary endpoints

• {"endpoint_text":"- Incidence of solicited local (injection site) and systemic AEs in the 7-days post-vaccination.","definition_or_measurement_approach":"Solicited local and systemic adverse events collected/reported during the 7 days following vaccination; incidence rates calculated."}
• {"endpoint_text":"- Incidence of SAEs, unsolicited AEs and fatal AEs during the period of the study.","definition_or_measurement_approach":"Serious adverse events, unsolicited adverse events and fatal events recorded for the duration of the study; incidence determined over study period."}

Methods

• Recruitment through the annual influenza vaccination program in the Stockholm region (study uses licensed Vaxigrip as part of the regional vaccination program)

Sweden

Earliest CTIS Part Ii Submission Date

11-12-2025

Latest Decision Or Authorization Date

23-12-2025

Processing Time Days

12

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Region Stockholm – SLSO

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden