Vaccine ReactionPhase 4INFLUOMICSNCT05154383

Effect of High-Dose Quadrivalent Influenza Vaccine (Efluelda®) Versus Standard-Dose (QIV-SD), in Subjects 65 Years of Age and Older on Innate Immunity, Including Gene Expression

A Phase 4 study testing Experimental arm : High-Dose Quadrivalent Influenza Vaccine (Efluelda) and Active Comparator: Standard-Dose Quadrivalent Influenza Vaccine in people with Vaccine Reaction, run by Centre Hospitalier Annecy Genevois at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate innate and adaptive immunity following QIV-HD vaccination compared to QIV-SD vaccination in people 65 years of age and older. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Vaccine Reaction
What is being tested?: Experimental arm : High-Dose Quadrivalent Influenza Vaccine (Efluelda) and Active Comparator: Standard-Dose Quadrivalent Influenza Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesFrance
Study dates: 15 Nov 2021to 21 Jul 2022
Phase: Phase 4
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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Aged 65 years or older, the day of inclusion;
Have signed and dated Informed Consent Form;
Able and willing to attend all scheduled visits, and to comply with study procedures;
Covered by French health insurance.
Non-Inclusion Criteria :
Any vaccine injection (including COVID-19 vaccine) in the 4 weeks preceding study inclusion;

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Plan to receive any vaccine (including COVID-19 vaccine) in the 4 weeks following study inclusion;
Already vaccinated against influenza for 2021-2022 season;
Hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances;
HIV infection;
Active Hepatitis B, or active Hepatitis C;
Previous Guillain Barré syndrome;
Ongoing immunosuppressive treatment or active immunodeficiency;
Receipt of immune globulins, blood or blood-derived products in the past 3 months;
Thrombocytopenia or bleeding disorder, receipt of anticoagulants contraindicating IM vaccination based on investigator's judgment;
Influenza-like illness symptoms, including COVID-19, within 4 weeks before study inclusion;
Personnes referred to in articles L1121-6 and L1121-8 of Public Health Code (persons deprived of liberty by judicial or administrative decision and persons subject to a legal protection measure: guardianship or curatorship).

Who cannot join

Any subject presenting with influenza-like illness symptoms, including COVID-19 between inclusion (visit 1) and randomization (visit 2);
Subject unable to attempt visit at Day 0 (visit 2) and Day 1 (visit 3);
Blood sample at Day 0 (visit 2) impossible to obtain;
Receipt of vaccine injection or equivalent between inclusion (visit 1) and randomization (visit 2), other than those allowed and planned in the study. This includes non-study dose of 2021-2022 influenza vaccine, blood-derived immune globulins, blood, or blood-derived products.
Any unexpected event relevant to the physician in charge, after discussion with the coordinating investigator and the sponsor

Trial locations and contacts

2 sites in 1 country.

France2 sites

Centre Hospitalier Annecy Genevois
Annecy, 74370
Centre Hospitalier Métropole Savoie
Chambéry

Other trials in France

About this study

The purpose of the study is to evaluate innate and adaptive immunity following QIV-HD vaccination compared to QIV-SD vaccination in people 65 years of age and older.

Read the detailed description

The hypothesis is that higher dose of antigen can increase the intensity and the quality of innate immunity, as the adaptive humoral and cellular responses.

In this study, the objectif is to evaluate innate and adaptive immunity following QIV-HD vaccination compared to QIV-SD vaccination in people 65 years of age and older.

Modifications of early blood molecular (transcriptome) and cellular (blood phenotyping) signatures within the first 24 hours following vaccination will be investigated. The association between early gene signature and late influenza-specific humoral immune responses weeks/months after vaccination will be also assessed.

This study is a hase IV, randomized, open-label, active-controlled, multi-center study comparing the immune response induced by QIV-HD vaccine (intervention) and QIV-SD vaccine (control).

Conditions: Vaccine Reaction
Being tested: Experimental arm : High-Dose Quadrivalent Influenza Vaccine (Efluelda), Active Comparator: Standard-Dose Quadrivalent Influenza Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental arm : High-Dose Quadrivalent Influenza Vaccine (Efluelda)Biological
Patient will received one dose of High Dose Quadrivalent Influenza Vaccine according to marketing authorization.
Active Comparator: Standard-Dose Quadrivalent Influenza VaccineBiological
Patient will received one dose of Standard Dose Quadrivalent Influenza Vaccine according to marketing authorization.

Study groups in NCT05154383
Study group	Role	What they receive
High-Dose Quadrivalent Influenza Vaccine	Experimental	One injection of the high-dose Efluelda vaccine will be given to the patient Receives: Biological: Experimental arm : High-Dose Quadrivalent Influenza Vaccine (Efluelda)
Standard-Dose Quadrivalent Influenza Vaccine	Active comparator	One injection of the standard-dose Influvactetra vaccine will be given to the patient Receives: Biological: Active Comparator: Standard-Dose Quadrivalent Influenza Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of Transcriptomic profiles
Transcriptomic profiles of blood cells (microarrays) will be performed to measure early systemic innate immune response
Measured: Change from Baseline Transcriptomic profiles at day after vaccine injection (Day 1)
Change of Innate cellular phenotyping
Innate cellular phenotyping will be performed using 36 surface markers deciphering lineage cells monocytes, neutrophils, NK, antigen-presenting cells.
Measured: Change from Baseline Innate cellular phenotyping at day after vaccine injection (Day 1)
Change of Gene signature
Study of the transcriptional profile of the blood cells by microarrays
Measured: Change from Baseline Gene signature at day after vaccine injection (Day 1)
Humoral immune responses
HAI titers, Individual HAI titers ratio, Subjects with titers ≥ 40, Seroconversion
Measured: Day 0, Day 21, Day 90 and Day 210 time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 202121 Jul 2022

First posted13 Dec 2021
Study start15 Nov 2021
Primary completion21 Jul 2022
Study completion21 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Vaccine ReactionStudies of the same condition, open and under way.
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 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05154383
Sponsor's protocol ID: 21-05
Acronym: INFLUOMICS
Status last verified: Nov 2021
First submitted: 3 Nov 2021
Last updated: 8 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vaccine Reaction trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of High-Dose Quadrivalent Influenza Vaccine (Efluelda®) Versus Standard-Dose (QIV-SD), in Subjects 65 Years of Age and Older on Innate Immunity, Including Gene Expression
ClinicalTrials.gov ID: NCT05154383
Acronym / sponsor ID: INFLUOMICS / 21-05
Conditions: Vaccine Reaction
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Centre Hospitalier Annecy GenevoisUniversity, hospital or other
Collaborators: Sanofi Pasteur, a Sanofi Company, Euraxi Pharma, Hospices Civils de Lyon, Institut National de la Santé Et de la Recherche Médicale, France, Eurofins Optimed
Study start: 15 Nov 2021 (actual)
Primary completion: 21 Jul 2022 (actual)
Study completion: 21 Jul 2022 (actual)
First posted: 13 Dec 2021 (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.

The purpose of the study is to evaluate innate and adaptive immunity following QIV-HD vaccination compared to QIV-SD vaccination in people 65 years of age and older.

Detailed description

The hypothesis is that higher dose of antigen can increase the intensity and the quality of innate immunity, as the adaptive humoral and cellular responses.

In this study, the objectif is to evaluate innate and adaptive immunity following QIV-HD vaccination compared to QIV-SD vaccination in people 65 years of age and older.

This study is a hase IV, randomized, open-label, active-controlled, multi-center study comparing the immune response induced by QIV-HD vaccine (intervention) and QIV-SD vaccine (control).

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
High-Dose Quadrivalent Influenza Vaccine	Experimental	Biological: Experimental arm : High-Dose Quadrivalent Influenza Vaccine (Efluelda)One injection of the high-dose Efluelda vaccine will be given to the patient
Standard-Dose Quadrivalent Influenza Vaccine	Active comparator	Biological: Active Comparator: Standard-Dose Quadrivalent Influenza VaccineOne injection of the standard-dose Influvactetra vaccine will be given to the patient

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (17 listed)

Aged 65 years or older, the day of inclusion;
Have signed and dated Informed Consent Form;
Able and willing to attend all scheduled visits, and to comply with study procedures;
Covered by French health insurance.
Any vaccine injection (including COVID-19 vaccine) in the 4 weeks preceding study inclusion;

Key exclusion criteria (5 listed)

Any subject presenting with influenza-like illness symptoms, including COVID-19 between inclusion (visit 1) and randomization (visit 2);
Subject unable to attempt visit at Day 0 (visit 2) and Day 1 (visit 3);
Blood sample at Day 0 (visit 2) impossible to obtain;
Receipt of vaccine injection or equivalent between inclusion (visit 1) and randomization (visit 2), other than those allowed and planned in the study. This includes non-study dose of 2021-2022 influenza vaccine, blood-derived immune globulins, blood, or blood-derived products.
Any unexpected event relevant to the physician in charge, after discussion with the coordinating investigator and the sponsor

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
Experimental arm : High-Dose Quadrivalent Influenza Vaccine (Efluelda)Patient will received one dose of High Dose Quadrivalent Influenza Vaccine according to marketing authorization.	Biological	High-Dose Quadrivalent Influenza Vaccine
Active Comparator: Standard-Dose Quadrivalent Influenza VaccinePatient will received one dose of Standard Dose Quadrivalent Influenza Vaccine according to marketing authorization.	Biological	Standard-Dose Quadrivalent Influenza Vaccine

Primary outcome

Change of Transcriptomic profiles
Time frame: Change from Baseline Transcriptomic profiles at day after vaccine injection (Day 1)
Transcriptomic profiles of blood cells (microarrays) will be performed to measure early systemic innate immune response
Change of Innate cellular phenotyping
Time frame: Change from Baseline Innate cellular phenotyping at day after vaccine injection (Day 1)
Innate cellular phenotyping will be performed using 36 surface markers deciphering lineage cells monocytes, neutrophils, NK, antigen-presenting cells.
Change of Gene signature
Time frame: Change from Baseline Gene signature at day after vaccine injection (Day 1)
Study of the transcriptional profile of the blood cells by microarrays
Humoral immune responses
Time frame: Day 0, Day 21, Day 90 and Day 210 time
HAI titers, Individual HAI titers ratio, Subjects with titers ≥ 40, Seroconversion

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 8 Aug 2022.
Individual participant dataSharing planned: No

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RecruitingPhase 1
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Not yet recruitingPhase 4
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RecruitingObservational study
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Vaccine Reaction, Zoster

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.

Cecile JANSSEN principal investigator

CH Annecy Genevois

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 17 inclusion and 5 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 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Change of Transcriptomic profiles (time frame: Change from Baseline Transcriptomic profiles at day after vaccine injection (Day 1)). The study lists 4 primary outcomes in all. 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 NCT05154383.

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 8 Aug 2022.