Influenza ImmunizationPhase 3NCT05513391
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
A Phase 3 study testing Recombinant influenza vaccine (RIV4) and Quadrivalent influenza vaccine (IIV4) in people with Influenza Immunization, run by Sanofi Pasteur, a Sanofi Company at 31 sites in 3 countries.
Trial summary
The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity… Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Immunization
- What is being tested?
- Recombinant influenza vaccine (RIV4) and Quadrivalent influenza vaccine (IIV4)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 31 sitesin 3 countries
- Study dates
- 10 Nov 2022to 3 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 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 3 to 8 years on the day of inclusion
- Assent form has been signed and dated by the participant (according to local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations
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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Trial locations and contacts
31 sites in 3 countries.
31 sites in 3 countries
United States18 sites
Kentucky Pediatrics / 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
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- New Orleans Site Number : 8400012
New Orleans, Louisiana, 70119
AMR - Newton Site Number : 8400021
Newton, Kansas, 67114
Coastal Carolina Research Center Site Number : 8400022
North Charleston, South Carolina, 29405
Velocity Clinical Research Omaha Site Number : 8400009
Omaha, Nebraska, 68134
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
Alliance for Multispecialty Research Syracuse Site Number : 8400027
Syracuse, Utah, 84075-9645
Velocity Clinical Research Vestal Site Number : 8400016
Vestal, New York, 13850
Poland7 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 : 6160005
Siemianowice Śląskie, Silesian Voivodeship, 41-103
Investigational Site Number : 6160006
Tarnów, 33-100
Investigational Site Number : 6160001
Warsaw, 02-647
Investigational Site Number : 6160012
Wroclaw, 53-149
Spain6 sites
Investigational Site Number : 7240014
Madrid, Madrid, Comunidad de, 28046
Investigational Site Number : 7240004
Madrid, 28041
Investigational Site Number : 7240018
Madrid, 28660
Investigational Site Number : 7240005
Málaga, 29015
Investigational Site Number : 7240001
Móstoles, 28938
Investigational Site Number : 7240007
Seville, 41014
About this study
Official title: Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine Compared With Egg-Based Standard-Dose Quadrivalent Influenza Vaccine in Children 3 to 8 Years of Age.
The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of RIV4 compared to IIV4 in participants aged 3 to 8 years.
Read the detailed description
Participants were enrolled on the day of their first vaccination and received 1 or 2 doses 28 days apart of either RIV4 or IIV4; depending on if they were previously vaccinated against influenza or previously unvaccinated against influenza, respectively; and were followed for 6 months after the last vaccination.
- Conditions
- Influenza Immunization
- Being tested
- Recombinant influenza vaccine (RIV4), Quadrivalent influenza vaccine (IIV4)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant influenza vaccine (RIV4)Biological
Also called Supemtek / Flublok Quadrivalent
Pharmaceutical form: solution for injection Route of administration: intramuscular
Quadrivalent influenza vaccine (IIV4)Biological
Also called Fluarix Tetra / Fluarix® Quadrivalent
Pharmaceutical form: suspension for injection Route of administration: intramuscular
| Study group | Role | What they receive |
|---|---|---|
| RIV4 cohort | Experimental | RIV4 single injection at Day 1 Receives: Biological: Recombinant influenza vaccine (RIV4) |
| IIV4 cohort | Active comparator | IIV4, single injection at Day 1 Receives: Biological: Quadrivalent influenza vaccine (IIV4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination
GMTs of influenza vaccine antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
Measured: Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]
Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination
Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain. SC was defined as either a pre-vaccination HAI titer less than (<) 10 (1/dilution) and a post-vaccination titer greater than or equal to (≥) 40 (1/dilution) or a pre-vaccination titer ≥ 10 (1/dilution) and a ≥ 4-fold increase in post-vaccination titer.
Measured: Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]
Secondary outcomes (8)
GMTs of Influenza Vaccine Antibodies at Day 1
GMTs of influenza vaccine antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
Measured: Pre-vaccination on Day 1
Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination
Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
Measured: Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated)
Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies
GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs of influenza vaccine antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
Measured: Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated)
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study 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, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination.
Measured: Within 30 minutes post-vaccination on Day 1 (all participants) and Day 29 (participants previously unvaccinated)
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Solicited injection site reactions were reactions at and around the injection/administration site of the investigational medicinal product (IMP) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF and considered as being related to the IMP administered at that site. Solicited systemic reactions were systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF, and those occurring during the specified collection period were always considered related to the IMP even if there was evidence of alternative etiology.
Measured: Day 1 to Day 8 (all participants); Day 29 to Day 36 (participants previously unvaccinated)
Number of Participants With Unsolicited AEs
An AE was any untoward medical occurrence in a clinical study 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, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Measured: Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated)
Number of Participants With Medically Attended Adverse Events (MAAEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department.
Measured: Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated)
Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)
An SAE was defined as any adverse event 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 other medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate.
Measured: From the first vaccination up to 6 months after the last vaccination, 209 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start10 Nov 2022
- Primary completion3 Oct 2023
- Study completion3 Oct 2023
Why it stopped: Sponsor decision to prematurely stop the study. This decision was made without any safety concerns.
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513391
- Sponsor's protocol ID
- VAP00026
- Other IDs
- U1111-1256-8841, VAP00026, 2022-000576-19
- 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
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 Compared With Egg-Based Standard-Dose Quadrivalent Influenza Vaccine in Children 3 to 8 Years of Age.
- ClinicalTrials.gov ID
- NCT05513391
- Acronym / sponsor ID
- VAP00026
- Conditions
- Influenza Immunization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to prematurely stop the study. This decision was made without any safety concerns.
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Posted 24 Jul 2024
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 this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of RIV4 compared to IIV4 in participants aged 3 to 8 years.
Detailed description
Participants were enrolled on the day of their first vaccination and received 1 or 2 doses 28 days apart of either RIV4 or IIV4; depending on if they were previously vaccinated against influenza or previously unvaccinated against influenza, respectively; and were followed for 6 months after the last vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIV4 cohort | Experimental | Biological: Recombinant influenza vaccine (RIV4)RIV4 single injection at Day 1 |
| IIV4 cohort | Active comparator | Biological: Quadrivalent influenza vaccine (IIV4)IIV4, single injection at Day 1 |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged 3 to 8 years on the day of inclusion
- Assent form has been signed and dated by the participant (according to local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations
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 |
|---|---|---|
| Recombinant influenza vaccine (RIV4)Also: Supemtek / Flublok QuadrivalentPharmaceutical form: solution for injection Route of administration: intramuscular | Biological | RIV4 cohort |
| Quadrivalent influenza vaccine (IIV4)Also: Fluarix Tetra / Fluarix® QuadrivalentPharmaceutical form: suspension for injection Route of administration: intramuscular | Biological | IIV4 cohort |
Primary outcome
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination
Time frame: Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]
GMTs of influenza vaccine antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination
Time frame: Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]
Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain. SC was defined as either a pre-vaccination HAI titer less than (<) 10 (1/dilution) and a post-vaccination titer greater than or equal to (≥) 40 (1/dilution) or a pre-vaccination titer ≥ 10 (1/dilution) and a ≥ 4-fold increase in post-vaccination titer.
8 secondary outcomes
GMTs of Influenza Vaccine Antibodies at Day 1
Time frame: Pre-vaccination on Day 1
Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination
Time frame: Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated)
Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies
Time frame: Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated)
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Time frame: Within 30 minutes post-vaccination on Day 1 (all participants) and Day 29 (participants previously unvaccinated)
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Time frame: Day 1 to Day 8 (all participants); Day 29 to Day 36 (participants previously unvaccinated)
Number of Participants With Unsolicited AEs
Time frame: Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated)
Number of Participants With Medically Attended Adverse Events (MAAEs)
Time frame: Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated)
Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)
Time frame: From the first vaccination up to 6 months after the last vaccination, 209 days
Results and safety
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.
- VAP00026 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
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant influenza vaccine (RIV4) and Quadrivalent influenza vaccine (IIV4) in people with Influenza Immunization, run by Sanofi Pasteur, a Sanofi Company at 31 sites in 3 countries.
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 2 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: stopped early, 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 31 sites in United States, Poland, Spain. 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 24 Jul 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) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination (time frame: Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]). 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?
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.