Influenza ImmunizationPhase 3NCT05513053

Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.

A Phase 3 study testing Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH in people with Influenza Immunization, run by Sanofi Pasteur, a Sanofi Company at 35 sites in 4 countries.

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 this study was to demonstrate the non-inferiority (NI) of the HAI immune response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile of RIV4 in all participants. Read more about this study

Who is it for?: Ages 9 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Influenza Immunization
What is being tested?: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,308 participants
Where: 35 sitesin 4 countries
Study dates: 27 Oct 2022to 27 Oct 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 9 to 49 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Aged 9 to 49 years on the day of inclusion
A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies: 1) was of non-childbearing potential. To be considered of non-childbearing potential, a female should have been pre-menarche, post-menopausal for at least 1 year, or surgically sterile OR 2) was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 4 weeks after the last study intervention administration
Assent form or informed consent form had been signed and dated by the participant (based on local regulations), and if applicable informed consent form had been signed and dated by the parent(s) or another legally acceptable representative

Who cannot join

Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
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
Thrombocytopenia
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the Investigator's judgment
Personal or family history of Guillain-Barre Syndrome (GBS)
Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder NOTE: The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

35 sites in 4 countries.

Country

City, postcode or hospital

35 sites in 4 countries

United States21 sites

Benchmark Research - Austin Site Number : 8400004
Austin, Texas, 78705
Kentucky Pediatics / Adult Research Site Number : 8400010
Bardstown, Kentucky, 40004
Rainbow Pediatrics Site Number : 8400014
Barnwell, South Carolina, 29812
Meridian Clinical Research Site Number : 8400006
Binghamton, New York, 13905
Alabama Clinical Therapeutics North Tower Site Number : 8400024
Birmingham, Alabama, 35205
Birmingham Pediatric Associates Site Number : 8400023
Birmingham, Alabama, 35205
Coastal Pediatric Research Charleston Site Number : 8400005
Charleston, South Carolina, 29414
Ohio Pediatric Research Site Number : 8400020
Dayton, Ohio, 45414
The Children's Clinic Of Jonesboro PA Site Number : 8400025
Jonesboro, Arkansas, 72401
Velocity Clinical Research Lincoln Site Number : 8400013
Lincoln, Nebraska, 68510
Velocity Clinical Research Site Number : 8400012
New Orleans, Louisiana, 70119
AMR - Newton Site Number : 8400021
Newton, Kansas, 67114
Meridian Clinical Research Norfolk Site Number : 8400011
Norfolk, Nebraska, 68701
Coastal Carolina Research Center - N Charleston Site Number : 8400022
North Charleston, South Carolina, 29405
Velocity Clinical Research, Omaha Site Number : 8400009
Omaha, Nebraska, 68134
Velocity Clinical Research Portsmouth Site Number : 8400015
Portsmouth, Virginia, 23703
JBR Clinical Research Site Number : 8400001
Salt Lake City, Utah, 84107
J. Lewis Research Site Number : 8400017
Salt Lake City, Utah, 84109
California Research Foundation Site Number : 8400003
San Diego, California, 92123-1881
Meridian Clinical Research- Sioux City Site Number : 8400007
Sioux City, Iowa, 51106
Velocity Clinical Research Vestal Site Number : 8400016
Vestal, New York, 13850

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Poland8 sites

Investigational Site Number : 6160010
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048
Investigational Site Number : 6160007
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079
Investigational Site Number : 6160003
Bydgoszcz, 85-796
Investigational Site Number : 6160004
PuÅ'awy, Lubusz Voivodeship, 24-100
Investigational Site Number : 6160005
Siemianowice Śląskie, Silesian Voivodeship, 41-103
Investigational Site Number : 6160006
Tarnów, 33-100
Investigational Site Number : 6160008
Warsaw, 02-637
Investigational Site Number : 6160012
Wroclaw, 53-149

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Spain5 sites

Investigational Site Number : 7240006
Centelles, Barcelona [Barcelona], 08540
Investigational Site Number : 7240018
Madrid, 28660
Investigational Site Number : 7240005
Málaga, 29015
Investigational Site Number : 7240001
Móstoles, 28938
Investigational Site Number : 7240007
Seville, 41014

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Czechia1 site

Investigational Site Number : 2030001
Jindřichův Hradec, 37701

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About this study

Official title: Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) in Children and Adolescents Aged 9 to 17 Years and Adults Aged 18 to 49 Years.

Read the detailed description

The participation duration was approximately 6 months for each participant.

Conditions: Influenza Immunization
Being tested: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
Medical subject headings: Influenza, Human

What participants receive

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

Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NHBiological
Also called Supemtek / Flublok Quadrivalent
Pharmaceutical form: Solution for injection Route of administration: intramuscular

Study groups in NCT05513053
Study group	Role	What they receive
Group 9 to 17 years old	Experimental	Participants of 9 to 17 years old who received RIV4 single intramuscular (IM) injection at D01 Receives: Biological: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
Group 18 to 49 years old	Experimental	Participants of 18 to 49 years old who received RIV4 single intramuscular (IM) injection at D01 Receives: Biological: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH

What is being measured

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

Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29
GMTs of anti-influenza antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.
Measured: Day 29
Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29
Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (<) 1:10 (1/dilution) at Day 1 and a post-vaccination titer greater than or equal to (>=) 1: 40 (1/dilution) at Day 29 or a pre-vaccination titer >= 1:10 at Day 1 and a >= 4-fold increase in post-vaccination titer.
Measured: Day 29

Secondary outcomes (8)

GMTs Against Influenza Vaccine Antibodies at Day 1
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.
Measured: Pre-vaccination on Day 1
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29
Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers >=10 and >=40 against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.
Measured: On Days 1 and 29
Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies
GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.
Measured: On Days 1 and 29
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical investigation participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs.
Measured: Within 30 minutes post-vaccination on Day 1
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRF and considered as related to the study intervention administered. An injection site reaction was an AR at and around the injection site and were commonly inflammatory reactions. Solicited systemic reactions were systemic AEs and those occurring during the specified collection period were always considered related to the intervention even if there was evidence of alternative etiology.
Measured: From Day 1 up to 7 days post-vaccination (up to Day 8)
Number of Participants With Unsolicited AEs
An AE was any untoward medical occurrence in a clinical investigation participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination.
Measured: From Day 1 up to 28 days post-vaccination (up to Day 29)
Number of Participants With Medically Attended Adverse Events (MAAEs)
An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or emergency department.
Measured: From Day 1 up to 28 days post-vaccination (up to Day 29)
Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.
Measured: From Day 1 up to 6 months post-vaccination, 181 days

Timeline

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

27 Oct 202227 Oct 2023

First posted23 Aug 2022
Study start27 Oct 2022
Primary completion27 Oct 2023
Study completion27 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Influenza ImmunizationStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,308 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05513053
Sponsor's protocol ID: VAP00027
Other IDs: U1111-1260-4678, VAP00027, 2022-000577-11
Status last verified: Sep 2025
First submitted: 22 Aug 2022
Last updated: 9 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

Folegatti PM, Pepin S, Tabar C, Fries K, Talanova O, See S, Essink B, Bertoch T, Drazan D, Natalini Martinez S, Konieczny M, Kaas-Leach K, De Bruijn I. Comparative assessment of immunogenicity and safety of recombinant influenza vaccine in children, adolescents, and adults: results from a phase 3, immunobridging, open-label, non-randomised study. Lancet Infect Dis. 2025 Oct;25(10):1097-1105. doi: 10.1016/S1473-3099(25)00153-7. Epub 2025 May 21.
PubMed 40412421

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?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) in Children and Adolescents Aged 9 to 17 Years and Adults Aged 18 to 49 Years.
ClinicalTrials.gov ID: NCT05513053
Acronym / sponsor ID: VAP00027
Conditions: Influenza Immunization
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,308 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 27 Oct 2022 (actual)
Primary completion: 27 Oct 2023 (actual)
Study completion: 27 Oct 2023 (actual)
First posted: 23 Aug 2022 (actual)
Results: Posted 30 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The participation duration was approximately 6 months for each participant.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 9 to 17 years old	Experimental	Biological: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NHParticipants of 9 to 17 years old who received RIV4 single intramuscular (IM) injection at D01
Group 18 to 49 years old	Experimental	Biological: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NHParticipants of 18 to 49 years old who received RIV4 single intramuscular (IM) injection at D01

Who may qualify

Ages: 9 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Aged 9 to 49 years on the day of inclusion
A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies: 1) was of non-childbearing potential. To be considered of non-childbearing potential, a female should have been pre-menarche, post-menopausal for at least 1 year, or surgically sterile OR 2) was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 4 weeks after the last study intervention administration
Assent form or informed consent form had been signed and dated by the participant (based on local regulations), and if applicable informed consent form had been signed and dated by the parent(s) or another legally acceptable representative

Key exclusion criteria (6 listed)

Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
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
Thrombocytopenia
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the Investigator's judgment
Personal or family history of Guillain-Barre Syndrome (GBS)

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
Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NHAlso: Supemtek / Flublok QuadrivalentPharmaceutical form: Solution for injection Route of administration: intramuscular	Biological	Group 18 to 49 years old, Group 9 to 17 years old

Primary outcome

Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29
Time frame: Day 29
GMTs of anti-influenza antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.
Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29
Time frame: Day 29
Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (<) 1:10 (1/dilution) at Day 1 and a post-vaccination titer greater than or equal to (>=) 1: 40 (1/dilution) at Day 29 or a pre-vaccination titer >= 1:10 at Day 1 and a >= 4-fold increase in post-vaccination titer.

8 secondary outcomes

GMTs Against Influenza Vaccine Antibodies at Day 1
Time frame: Pre-vaccination on Day 1
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29
Time frame: On Days 1 and 29
Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies
Time frame: On Days 1 and 29
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Time frame: Within 30 minutes post-vaccination on Day 1
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Time frame: From Day 1 up to 7 days post-vaccination (up to Day 8)
Number of Participants With Unsolicited AEs
Time frame: From Day 1 up to 28 days post-vaccination (up to Day 29)
Number of Participants With Medically Attended Adverse Events (MAAEs)
Time frame: From Day 1 up to 28 days post-vaccination (up to Day 29)
Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)
Time frame: From Day 1 up to 6 months post-vaccination, 181 days

Results and safety

Results posted to the registry on 30 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Participants Aged 9 to 17 Years	648	629
Cohort 2: Participants Aged 18 to 49 Years	660	635

Primary outcome: Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29

Time frame: Day 29. Geometric mean (95% Confidence Interval). Unit: titer

Measure	Cohort 1: Participants Aged 9 to 17 Years n = 609	Cohort 2: Participants Aged 18 to 49 Years n = 606
A/H1N1	1946 (1795 to 2109)	982 (881 to 1094)
A/H3N2	1975 (1771 to 2202)	604 (531 to 687)
B/Victoria	405 (362 to 452)	258 (233 to 285)
B/Yamagata	1941 (1779 to 2118)	1593 (1477 to 1717)

Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: GMT Ratio: 1.98 (95% CI 1.73 to 2.27)
Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: GMT Ratio: 3.27 (95% CI 2.76 to 3.87)
Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: GMT Ratio: 1.57 (95% CI 1.35 to 1.82)

Population analysed: Analysis was performed on the Per-protocol analysis set (PPAS)-subset of full analysis set (FAS) which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample.

Primary outcome: Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29

Time frame: Day 29. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort 1: Participants Aged 9 to 17 Years n = 609	Cohort 2: Participants Aged 18 to 49 Years n = 606
A/H1N1	78.3 (74.8 to 81.5)	76.4 (72.8 to 79.7)
A/H3N2	86.5 (83.6 to 89.1)	87.1 (84.2 to 89.7)
B/Victoria	76.8 (73.3 to 80.1)	73.6 (69.8 to 77.0)
B/Yamagata	77.2 (73.6 to 80.5)	62.9 (58.9 to 66.7)

Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: Percent Difference: 1.92 (95% CI -2.78 to 6.62)
Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: Percent Difference: -0.59 (95% CI -4.41 to 3.23)
Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: Percent Difference: 3.29 (95% CI -1.57 to 8.14)

Population analysed: Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Only participants with data collected for each category at Day 29 are reported.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 up to 6 months post-vaccination, 181 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Participants Aged 9 to 17 Years	3 of 641 (0.5%)	263 of 641 (41%)	0 of 641
Cohort 2: Participants Aged 18 to 49 Years	7 of 658 (1.1%)	336 of 658 (51.1%)	0 of 658

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40412421Folegatti PM, Pepin S, Tabar C, Fries K, Talanova O, See S, Essink B, Bertoch T, Drazan D, Natalini Martinez S, Konieczny M, Kaas-Leach K, De Bruijn I. Comparative assessment of immunogenicity and safety of recombinant influenza vaccine in children, adolescents, and adults: results from a phase 3, immunobridging, open-label, non-randomised study. Lancet Infect Dis. 2025 Oct;25(10):1097-1105. doi: 10.1016/S1473-3099(25)00153-7. Epub 2025 May 21.
VAP00027 Plain Language Results SummaryLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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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.

Clinical Sciences & Operations study director

Sanofi Pasteur, a Sanofi Company

35 sites in 4 countries: 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 3 inclusion and 6 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 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Poland, Spain, Czechia. 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?

Yes. Results are posted in the registry (first posted 30 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 (time frame: Day 29). The study lists 2 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 NCT05513053, 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 9 Sep 2025.