Status:
COMPLETED
Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Sanofi Pasteur, a Sanofi Company
Hospices Civils de Lyon
Conditions:
Morbid Obesity
Severe Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Obesity has been considered as a risk factor for mortality and development of complications during infection with the influenza virus. Several case studies of severe and fatal infections have identifi...
Detailed Description
Obese adults are at higher risk of complications and mortality due to influenza infections than healthy adults. The few studies available showed lower vaccine response in obese patients compared to he...
Eligibility Criteria
Inclusion
- ≥18 and ≤75 years old
- Body Mass Index (BMI) ≥35 kg/m2
- No previous vaccination against influenza (in the preceding 6 months) with either the trial vaccine or another vaccine
- 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 15 days prior to enrolment.
- Signed informed consent
- Participants covered by social security regimen .
Exclusion
- Known active infection with HIV and / or HBV (HBs antigen) and / or HCV (RNA positive viral load)
- 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
- Known acute evolving neurological disorder or history of Guillain-Barré syndrome.
- 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.
- Proven Influenza infection in the 6 months preceding the study
- 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.
- Receipt of any vaccine in the 2 weeks (14 days) preceding the trial vaccination
- History of bariatric surgery in the 2 years preceding the study.
- Bariatric surgery planned during the study period.
- Receipt of immune globulins, blood or blood-derived products in the 3 months preceding the study or planned during the study period.
- 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.
- Contraindication to intramuscular injection
- Female subjects of childbearing potential :
- without an adequate contraception (see chapter 5.8) for 30 days prior to vaccination within the context of the study,
- breastfeeding
- with a positive pregnancy test on the day of vaccination,
- did not agreed to continue adequate contraception during 2 months after completion of the vaccination.
- 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
- 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.
Key Trial Info
Start Date :
November 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2023
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT05409612
Start Date
November 7 2022
End Date
October 3 2023
Last Update
February 26 2024
Active Locations (1)
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1
Pitie-Salpêtrière hospital APHP
Paris, France, 75013