Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients (FLUO)

This is an interventional prevention trial for Morbid Obesity focused on measuring Obesity, influenza vaccine, immunological response, RIV4 Read More

Inclusion Criteria:

1. ≥18 and ≤75 years old
2. Body Mass Index (BMI) ≥35 kg/m2
3. No previous vaccination against influenza (in the preceding 6 months) with either the trial vaccine or another vaccine
4. Absence of health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment.
5. Signed informed consent
6. Participants covered by social security regimen .

Exclusion Criteria:

1. Known active infection with HIV and / or HBV (HBs antigen) and / or HCV (RNA positive viral load)
2. Immunodepression or diagnosis of having congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory, bowel disease, or other autoimmune condition
3. Known acute evolving neurological disorder or history of Guillain-Barré syndrome.
4. Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (tympanic temperature ≥38°C on the day of vaccination). A subject should not be included in the trial until the condition has resolved or the febrile event has subsided.
5. Proven Influenza infection in the 6 months preceding the study
6. Known systemic hypersensitivity to any of the vaccine components, including a documented allergy to egg proteins, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
7. Receipt of any vaccine in the 2 weeks (14 days) preceding the trial vaccination
8. History of bariatric surgery in the 2 years preceding the study.
9. Bariatric surgery planned during the study period.
10. Receipt of immune globulins, blood or blood-derived products in the 3 months preceding the study or planned during the study period.
11. Taking immunosuppressive treatment (including chemotherapy, oral corticosteroids with doses ≥10 mg/day of prednisone or equivalent during ≥15 days) or radiotherapy in the 6 months preceding the study or planned during the study.
12. Contraindication to intramuscular injection

13. Female subjects of childbearing potential may be enrolled in the study, only if the subject fulfill the 4 following criteria:

    • she has practiced adequate contraception (see chapter 5.8) for 30 days prior to vaccination,
    • she is not breastfeeding
    • she has a negative pregnancy test on the day of vaccination, and
    • she has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination.
14. Participation at the time of trial enrollment (or in the 4 weeks [28 days] preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
15. Anticipated inability to follow the protocol requirements (e.g. comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits). 16. Participants covered by AME.