Morbid ObesityPhase 3FLUONCT05409612
Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients
A Phase 3 study testing Supemtek® and Vaxigriptetra® in people with Morbid Obesity and Severe Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 identified possible effects of obesity on disease progression; these effects include extensive viral replication in the deep… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Morbid Obesity, Severe Obesity
- What is being tested?
- Supemtek® and Vaxigriptetra®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteFrance
- Study dates
- 7 Nov 2022to 3 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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 .
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Randomized, Open, Phase III, Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients
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 identified possible effects of obesity on disease progression; these effects include extensive viral replication in the deep lung, progression to viral pneumonia, and prolonged and increased viral shedding. These points may be linked to obesity which causes a chronic state of meta-inflammation with systemic implications for immunity: obese patients exhibit delayed and blunted innate and adaptive immune responses to influenza virus infection, and they experience poor recovery from the disease leading to an increased susceptibility to secondary bacterial infections and poor healing of the lung epithelium. Furthermore, in obese people, influenza virus may exploit the lack of antiviral pressure, generate a more virulent population and increase disease severity Due to the growing prevalence of obesity worldwide (500 million subjects in 2017), it is important to be able to offer vaccines that provide the highest protection for this at-risk population. The quadrivalent recombinant high-dose influenza vaccine has been shown to have greater immunogenicity and efficacy than standard influenza vaccine in non-obese adults older than 50 years. However, this vaccine has never been evaluated in obese subjects.
Investigators thus planned this trial to assess whether the use of the new quadrivalent recombinant high-dose influenza vaccine (RIV4) will induce a better immunological answer than current quadrivalent standard vaccine (SD) in patients with severe obesity, with an acceptable safety profile, thus leading to a better protection against influenza in this population at high risk of influenza complications.
Read the 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 healthy adults and moderate efficacy of standard influenza vaccines among these subjects.
Data from the population > 50 years show that a recombinant high dose quadrivalent vaccination strategy improve immunological and clinical efficacy against influenza with comparable rates of local and general solicited reactions.
Investigators hypothesize that the use of the new quadrivalent recombinant high-dose influenza vaccine (RIV4) will induce a better immunological answer than current quadrivalent standard vaccine (SD) in patients with severe obesity, with an acceptable safety profile, thus leading to a better protection against influenza in this population at high risk of influenza complications.
The primary objective is to assess if the immune response of the new quadrivalent recombinant high-dose influenza vaccine (RIV4) is superior to the current quadrivalent standard dose influenza vaccine (SD) in adult patients with severe obesity in terms of geometric mean titers (GMTs) for each strain at 1 month. The primary endpoint: Ratio (RIV4/SD) of GMTs of each of the 4 strains at 1-month post-vaccination. The ratio of GMTs will be computed by taking the antilog of the difference between means of log-transformed titers.
It is a Randomized, open, multicenter, trial in France, evaluating the immunological response and safety of two influenza vaccine strategies using a standard quadrivalent vaccine (Vaxigriptetra®) and the new high-dose recombinant quadrivalent vaccine (Supemtek®). The single administration of influenza vaccine will be performed at D0: Vaxigriptetra® or Supemtek® according to randomization allocation. Three follow-up visits will be performed at M1 and M6 during consultations in the clinical units where participants are usually followed. This multicenter research will involve the participation of the 10 centers in France (metropolitan France and French overseas departments and territories). Each hospital involves a single participating department. All investigational sites belong to the FORCE (national network of clinical research specializing in the study of obesity and associated metabolic diseases) or to the I-REIVAC (Innovative Clinical Research Network In Vaccinology). The duration of recruitment will be 5 months. The duration of participation for each participant will be 6 months, the total duration of the study will be 11 months. For this study, 206 patients will be recruited.
- Conditions
- Morbid Obesity, Severe Obesity
- Being tested
- Supemtek®, Vaxigriptetra®
- Keywords
- Obesity, influenza vaccine, immunological response, RIV4
- Medical subject headings
- Obesity, Morbid, Obesity, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supemtek®Biological
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).
Solution 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.
Vaxigriptetra®Biological
Quadrivalent inactivated influenza vaccine containing 15 µg of hemagglutinin (HA) for each of the 4 strains included. 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 group | Role | What they receive |
|---|---|---|
| Supemtek® arm | Active comparator | Patients recieving 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).
Solution 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. Receives: Biological: Supemtek® |
| Vaxigriptetra® arm | Active comparator | Patients receiving a quadrivalent inactivated influenza vaccine containing 15 µg of hemagglutinin (HA) for each of the 4 strains included. 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. Receives: Biological: Vaxigriptetra® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio (RIV4/SD) of geometric mean titers (GMTs) of each of the 4 strains at 1-month post-vaccination.obesity in terms of geometric mean titers (GMTs) for each strain at 1 month.
The ratio of GMTs will be computed by taking the antilog of the difference between means of log-transformed titers.
Measured: 1 month
Secondary outcomes (18)
seroconversion rate for each of the 4 strains at 1 month after vaccination
defined as pre-vaccination hemagglutination inhibition (HI) titer of <1:10 and post-vaccination titer ≥1:40 or pre-vaccination HI titer of ≥ 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.
Measured: 1 month
seroconversion rate for each of the 4 strains at 6 month after vaccination
(defined as pre-vaccination hemagglutination inhibition (HI) titer of <1:10 and post-vaccination titer ≥1:40 or pre-vaccination HI titer of ≥ 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).
Measured: 6 month
seroconversion factor (or geometric mean fold increase) for each of the 4 strains at 1 month after vaccination.
defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the day 0 reciprocal HI titer
Measured: 1 month
seroconversion factor (or geometric mean fold increase) for each of the 4 strains at 6 month after vaccination.
defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the day 0 reciprocal HI titer
Measured: 6 month
seroprotection rate defined as the post-vaccination HI titer ≥1:40 for each of the 4 strains at 1 month after vaccination.
seroprotection rate defined as the post-vaccination HI titer ≥1:40 for each of the 4 strains at 1 month after vaccination.
Measured: 1 month
seroprotection rate defined as the post-vaccination HI titer ≥1:40 for each of the 4 strains at 6 month after vaccination.
seroprotection rate defined as the post-vaccination HI titer ≥1:40 for each of the 4 strains at 6 month after vaccination.
Measured: 6 month
geometric means titers at 6 months after vaccination for each of the 4 strains.
geometric means titers at 6 months after vaccination for each of the 4 strains.
Measured: 6 month
Seroconversion rate of geometric mean titers (GMTs) of each of the 4 strains at 1 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
The ratio of GMTs will be computed by taking the antilog of the difference between means of log-transformed titers
Measured: 1 month
Seroconversion rate of geometric mean titers (GMTs) of each of the 4 strains at 6 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
The ratio of GMTs will be computed by taking the antilog of the difference between means of log-transformed titers
Measured: 6 month
seroconversion factor of geometric mean titers (GMTs) of each of the 4 strains at 1 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
The ratio of GMTs will be computed by taking the antilog of the difference between means of log-transformed titers
Measured: 1 month
seroconversion factor of geometric mean titers (GMTs) of each of the 4 strains at 6 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
The ratio of GMTs will be computed by taking the antilog of the difference between means of log-transformed titers
Measured: 6 month
seroprotection rate of geometric mean titers (GMTs) of each of the 4 strains at 1 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
The ratio of GMTs will be computed by taking the antilog of the difference between means of log-transformed titers
Measured: 1 month
seroprotection rate of geometric mean titers (GMTs) of each of the 4 strains at 6 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
The ratio of GMTs will be computed by taking the antilog of the difference between means of log-transformed titers
Measured: 6 month
ratio (RIV4/SD) of geometric mean titers (GMTs) of each of the 4 strains at 1 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
The ratio of GMTs will be computed by taking the antilog of the difference between means of log-transformed titers
Measured: 1 month
ratio (RIV4/SD) of geometric mean titers (GMTs) of each of the 4 strains at 6 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
The ratio of GMTs will be computed by taking the antilog of the difference between means of log-transformed titers
Measured: 6 month
Number and intensity of solicited reactogenicity events, clinical events within 7 days of vaccination and all other unsolicited adverse event during the study.
reactogenicity events : local (pain, tenderness, induration, redness, swelling) and general (tiredness, chills, joint pain, muscle pain, headache, nausea, fever)
Measured: 1 and 6 months
Identification of the influenza vaccine response determinants in terms of seroconversion for at least two strains after vaccination
considering age, sex, smoking, BMI, chronic conditions (e.g. diabetes mellitus), co-treatments, standard / recombinant vaccine
Measured: 1 and 6 months
Proven influenza cases during the study period.
A proven influenza infection will be defined as a positive influenza RT-PCR performed on a naso-pharyngeal swab at the time of the visit.
Measured: 1 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start7 Nov 2022
- Primary completion20 Apr 2023
- Study completion3 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company, Hospices Civils de Lyon
- Responsible party
- Sponsor
- Investigators
- Odile LAUNAY, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409612
- Sponsor's protocol ID
- APHP200039
- Other IDs
- 2021-002691-39
- Acronym
- FLUO
- Status last verified
- Jan 2024
- First submitted
- 20 May 2022
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Publications
Loubet P, Czernichow S, Giboin C, Sultan A, Guimard T, Disse E, Tavolacci MP, Ben Ghezala I, Ledoux S, Janssen C, Mosbah H, Lefebvre M, De Luca A, Nguyen LBL, Taillard V, Couster J, Duale C, Carette C, Rives-Lange C, Zemouri S, Desaint C, Tubach F, Launay O. Recombinant vs Standard Influenza Vaccine in Adults With Severe Obesity: A Randomized Clinical Trial. Clin Infect Dis. 2026 Sep 2;83(2):312-320. doi: 10.1093/cid/ciag200.
PubMed 41858049
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open, Phase III, Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients
- ClinicalTrials.gov ID
- NCT05409612
- Acronym / sponsor ID
- FLUO / APHP200039
- Conditions
- Morbid Obesity, Severe Obesity
- Keywords
- Obesity, influenza vaccine, immunological response, RIV4
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company, Hospices Civils de Lyon
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 identified possible effects of obesity on disease progression; these effects include extensive viral replication in the deep lung, progression to viral pneumonia, and prolonged and increased viral shedding. These points may be linked to obesity which causes a chronic state of meta-inflammation with systemic implications for immunity: obese patients exhibit delayed and blunted innate and adaptive immune responses to influenza virus infection, and they experience poor recovery from the disease leading to an increased susceptibility to secondary bacterial infections and poor healing of the lung epithelium. Furthermore, in obese people, influenza virus may exploit the lack of antiviral pressure, generate a more virulent population and increase disease severity Due to the growing prevalence of obesity worldwide (500 million subjects in 2017), it is important to be able to offer vaccines that provide the highest protection for this at-risk population. The quadrivalent recombinant high-dose influenza vaccine has been shown to have greater immunogenicity and efficacy than standard influenza vaccine in non-obese adults older than 50 years. However, this vaccine has never been evaluated in obese subjects.
Investigators thus planned this trial to assess whether the use of the new quadrivalent recombinant high-dose influenza vaccine (RIV4) will induce a better immunological answer than current quadrivalent standard vaccine (SD) in patients with severe obesity, with an acceptable safety profile, thus leading to a better protection against influenza in this population at high risk of influenza complications.
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 healthy adults and moderate efficacy of standard influenza vaccines among these subjects.
Data from the population > 50 years show that a recombinant high dose quadrivalent vaccination strategy improve immunological and clinical efficacy against influenza with comparable rates of local and general solicited reactions.
Investigators hypothesize that the use of the new quadrivalent recombinant high-dose influenza vaccine (RIV4) will induce a better immunological answer than current quadrivalent standard vaccine (SD) in patients with severe obesity, with an acceptable safety profile, thus leading to a better protection against influenza in this population at high risk of influenza complications.
The primary objective is to assess if the immune response of the new quadrivalent recombinant high-dose influenza vaccine (RIV4) is superior to the current quadrivalent standard dose influenza vaccine (SD) in adult patients with severe obesity in terms of geometric mean titers (GMTs) for each strain at 1 month. The primary endpoint: Ratio (RIV4/SD) of GMTs of each of the 4 strains at 1-month post-vaccination. The ratio of GMTs will be computed by taking the antilog of the difference between means of log-transformed titers.
It is a Randomized, open, multicenter, trial in France, evaluating the immunological response and safety of two influenza vaccine strategies using a standard quadrivalent vaccine (Vaxigriptetra®) and the new high-dose recombinant quadrivalent vaccine (Supemtek®). The single administration of influenza vaccine will be performed at D0: Vaxigriptetra® or Supemtek® according to randomization allocation. Three follow-up visits will be performed at M1 and M6 during consultations in the clinical units where participants are usually followed. This multicenter research will involve the participation of the 10 centers in France (metropolitan France and French overseas departments and territories). Each hospital involves a single participating department. All investigational sites belong to the FORCE (national network of clinical research specializing in the study of obesity and associated metabolic diseases) or to the I-REIVAC (Innovative Clinical Research Network In Vaccinology). The duration of recruitment will be 5 months. The duration of participation for each participant will be 6 months, the total duration of the study will be 11 months. For this study, 206 patients will be recruited.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supemtek® arm | Active comparator | Biological: Supemtek®Patients recieving 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). Solution 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. |
| Vaxigriptetra® arm | Active comparator | Biological: Vaxigriptetra®Patients receiving a quadrivalent inactivated influenza vaccine containing 15 µg of hemagglutinin (HA) for each of the 4 strains included. 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supemtek®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). Solution 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. | Biological | Supemtek® arm |
| Vaxigriptetra®Quadrivalent inactivated influenza vaccine containing 15 µg of hemagglutinin (HA) for each of the 4 strains included. 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. | Biological | Vaxigriptetra® arm |
Primary outcome
Ratio (RIV4/SD) of geometric mean titers (GMTs) of each of the 4 strains at 1-month post-vaccination.obesity in terms of geometric mean titers (GMTs) for each strain at 1 month.
Time frame: 1 month
The ratio of GMTs will be computed by taking the antilog of the difference between means of log-transformed titers.
18 secondary outcomes
seroconversion rate for each of the 4 strains at 1 month after vaccination
Time frame: 1 month
seroconversion rate for each of the 4 strains at 6 month after vaccination
Time frame: 6 month
seroconversion factor (or geometric mean fold increase) for each of the 4 strains at 1 month after vaccination.
Time frame: 1 month
seroconversion factor (or geometric mean fold increase) for each of the 4 strains at 6 month after vaccination.
Time frame: 6 month
seroprotection rate defined as the post-vaccination HI titer ≥1:40 for each of the 4 strains at 1 month after vaccination.
Time frame: 1 month
seroprotection rate defined as the post-vaccination HI titer ≥1:40 for each of the 4 strains at 6 month after vaccination.
Time frame: 6 month
geometric means titers at 6 months after vaccination for each of the 4 strains.
Time frame: 6 month
Seroconversion rate of geometric mean titers (GMTs) of each of the 4 strains at 1 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
Time frame: 1 month
Seroconversion rate of geometric mean titers (GMTs) of each of the 4 strains at 6 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
Time frame: 6 month
seroconversion factor of geometric mean titers (GMTs) of each of the 4 strains at 1 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
Time frame: 1 month
seroconversion factor of geometric mean titers (GMTs) of each of the 4 strains at 6 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
Time frame: 6 month
seroprotection rate of geometric mean titers (GMTs) of each of the 4 strains at 1 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
Time frame: 1 month
seroprotection rate of geometric mean titers (GMTs) of each of the 4 strains at 6 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
Time frame: 6 month
ratio (RIV4/SD) of geometric mean titers (GMTs) of each of the 4 strains at 1 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
Time frame: 1 month
ratio (RIV4/SD) of geometric mean titers (GMTs) of each of the 4 strains at 6 month after vaccination according to class of age (< or ≥ 50 years old) and BMI class ([35-40[ or ≥ 40 kg/m2).
Time frame: 6 month
Number and intensity of solicited reactogenicity events, clinical events within 7 days of vaccination and all other unsolicited adverse event during the study.
Time frame: 1 and 6 months
Identification of the influenza vaccine response determinants in terms of seroconversion for at least two strains after vaccination
Time frame: 1 and 6 months
Proven influenza cases during the study period.
Time frame: 1 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Derived from this study: PubMed 41858049Loubet P, Czernichow S, Giboin C, Sultan A, Guimard T, Disse E, Tavolacci MP, Ben Ghezala I, Ledoux S, Janssen C, Mosbah H, Lefebvre M, De Luca A, Nguyen LBL, Taillard V, Couster J, Duale C, Carette C, Rives-Lange C, Zemouri S, Desaint C, Tubach F, Launay O. Recombinant vs Standard Influenza Vaccine in Adults With Severe Obesity: A Randomized Clinical Trial. Clin Infect Dis. 2026 Sep 2;83(2):312-320. doi: 10.1093/cid/ciag200.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odile LAUNAY, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Supemtek® and Vaxigriptetra® in people with Morbid Obesity and Severe Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio (RIV4/SD) of geometric mean titers (GMTs) of each of the 4 strains at 1-month post-vaccination.obesity in terms of geometric mean titers (GMTs) for each strain at 1 month. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05409612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.