Obese adult patients with BMI =35 kg/m2 MedDRA version: 20.0 Level: HLT Classification code 10022005 Term: Influenza viral infections System Organ Class: 100000004862
Conditions
Interventions
Trade Name: VaxigripTetra
Product Name: VaxigripTetra
Product Code: VaxigripTetra
Pharmaceutical Form: Solution for injection in pre-filled injector
Trade Name: Supemtek
Product Name: Supemtek
Produc
Sponsors
Assistance Publique-Hôpitaux de Paris
Eligibility
Sex/Gender
All
Inclusion criteria
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 (except AME). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 206 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 206
Exclusion criteria
Exclusion criteria: 1. Known active infection with HIV and / or HBV (HBs antigen) and / or HCV (ARN positive viral load) 2. Known autoimmune or inflammatory disease or any other cause of severe immune deficiency 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 (temperature =38°C on the day of vaccination). A prospective 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, 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 4 weeks (28 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, 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 3 following criteria: - she has practiced adequate contraception (see chapter 5.8) for 30 days prior to vaccination, - 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 series. 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). Flublok® Quadrivalent is a quadrivalent recombinant high-dose influenza vaccine containing 45 µg of hemagglutinin (HA) for each of the 4 strains included (2 strains A and 2 strains B). Suspension for injection is sterile liquid supplied in 0.5mL single dose pre-filled syringe. Vaccine is injected intra-muscularly in the non-dominant arm at Day 0.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immunological efficacy of a quadrivalent recombinant high-dose influenza vaccine versus a quadrivalent standard dose inactivated influenza vaccine in adult patients with severe obesity in terms of seroconversion at 1 month. ;Secondary Objective: - To assess the immunological efficacy of a quadrivalent recombinant high dose influenza vaccine versus a standard dose inactivated influenza vaccine in terms of: seroconversion rate, seroconversion factor, seroprotection rate and geometric means of HI titers for each vaccine antigens, separately. - To assess the immunological efficacy of a quadrivalent recombinant high-dose influenza vaccine in particular subgroups of patients: according to class of age (1:10 and a 4-fold post-vaccination rise in antibody titer. Pre-vaccination titers are measured at inclusion and post-vaccination titers 1 month after vaccination. ;Timepoint(s) of evaluation of this end point: one month . | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To assess the immunological efficacy of a quadrivalent recombinant high dose influenza vaccine versus a standard dose inactivated influenza vaccine in terms of: seroconversion rate, seroconversion factor, seroprotection rate and geometric means of HI titers for each vaccine antigens, separately. 2. To assess the immunological efficacy of a quadrivalent recombinant high-dose influenza vaccine in particular subgroups of patients: according to class of age (1:10 and a 4-fold post-vaccination rise in antibody titer. Pre-vaccination titers are measured at inclusion and post-vaccination titers at 1 and 6 months after vaccination). 1. b) seroconversion factor (or geometric mean fold increase) defined as the geometric mean of the within-subject ratios of the postvaccination reciprocal HI titer to the day 0 reciprocal HI titer) for each of the 4 antigens at 1 and 6 months after vaccination. 1. c) seroprotection rate defined as the post-vaccination HI titer =1:40 for each of the 4 antigens at 1 and 6 months after vaccination. 1. d) geometric means of HI titers at 1 and 6 months after vaccination for each of the 4 antigens. 2. Seroconversion rate, seroconversion factor, seroprotection rate and geometric means of HI titers for each of the 4 antigens at 1 and 6 months after vaccination according to class of age (< or = 45 years old) and BMI class ([35-40[ or = 40 kg/m2). 3. Number and intensity of solicited reactogenicity events: local (pain, tenderness, redness, swelling) and general (fatigue, chills, joint pain, muscle pain, headache, nausea, fever), clinical events within 7 days of vaccination and all other unsolicited adverse event during the study. 4. Identification of the influenza vaccine response determinants in terms of seroconversion rate after vaccination (considering age, sex, smoking, BMI, diabetes mellitus, standard / recombinant vaccine). 5. Proven influenza cases during the study period. A proven influenza infection will be de | — |
Countries
France
Contacts
Public ContactPôle promotion
Assistance publique-Hôpitaux de Paris
Outcome results
None listed