INTERVENTIONAL RESEARCH PROTOCOL INVOLVING HUMAN PARTICIPANTS CONCERNING A MEDICINAL PRODUCT FOR HUMAN USE

Phase 1

• Conditions: Obese adult patients with BMI =35 kg/m2; MedDRA version: 20.0Level: HLTClassification code 10022005Term: Influenza viral infectionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-002691-39-FR
• Lead Sponsor: Assistance Publique-Hôpitaux de Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-13
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 206

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified