Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years

September 5, 2025 updated by: Sanofi Pasteur, a Sanofi Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
366

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial Transparency email recommended (Toll free number for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • Poland
      • Bydgoszcz, Poland, 85-796
        • Investigational Site Number : 6160003
      • Tarnów, Poland, 33-100
        • Investigational Site Number : 6160006
      • Warsaw, Poland, 02-647
        • Investigational Site Number : 6160001
      • Wroclaw, Poland, 53-149
        • Investigational Site Number : 6160012
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-048
        • Investigational Site Number : 6160010
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-079
        • Investigational Site Number : 6160007
    • Silesian Voivodeship
      • Siemianowice Śląskie, Silesian Voivodeship, Poland, 41-103
        • Investigational Site Number : 6160005
  • Spain
      • Madrid, Spain, 28041
        • Investigational Site Number : 7240004
      • Madrid, Spain, 28660
        • Investigational Site Number : 7240018
      • Málaga, Spain, 29015
        • Investigational Site Number : 7240005
      • Móstoles, Spain, 28938
        • Investigational Site Number : 7240001
      • Seville, Spain, 41014
        • Investigational Site Number : 7240007
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28046
        • Investigational Site Number : 7240014
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Birmingham Pediatric Associates Site Number : 8400023
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • The Children's Clinic Of Jonesboro PA Site Number : 8400025
    • California
      • San Diego, California, United States, 92123-1881
        • California Research Foundation Site Number : 8400003
    • Iowa
      • Sioux City, Iowa, United States, 51106
        • Meridian Clinical Research- Sioux City Site Number : 8400007
    • Kansas
      • Newton, Kansas, United States, 67114
        • AMR - Newton Site Number : 8400021
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatrics / Adult Research Site Number : 8400010
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Velocity Clinical Research- New Orleans Site Number : 8400012
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Velocity Clinical Research Lincoln Site Number : 8400013
      • Omaha, Nebraska, United States, 68134
        • Velocity Clinical Research Omaha Site Number : 8400009
    • New York
      • Binghamton, New York, United States, 13905
        • Meridian Clinical Research Site Number : 8400006
      • Vestal, New York, United States, 13850
        • Velocity Clinical Research Vestal Site Number : 8400016
    • Ohio
      • Dayton, Ohio, United States, 45414
        • Ohio Pediatric Research Site Number : 8400020
    • South Carolina
      • Barnwell, South Carolina, United States, 29812
        • Rainbow Pediatrics Site Number : 8400014
      • Charleston, South Carolina, United States, 29414
        • Coastal Pediatric Research Charleston Site Number : 8400005
      • North Charleston, South Carolina, United States, 29405
        • Coastal Carolina Research Center Site Number : 8400022
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • JBR Clinical Research Site Number : 8400001
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research Site Number : 8400017
      • Syracuse, Utah, United States, 84075-9645
        • Alliance for Multispecialty Research Syracuse Site Number : 8400027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RIV4 cohort
RIV4 single injection at Day 1
Biological: Recombinant influenza vaccine (RIV4)
Pharmaceutical form: solution for injection Route of administration: intramuscular
Other Names:
  • Supemtek / Flublok Quadrivalent
Active Comparator: IIV4 cohort
IIV4, single injection at Day 1
Biological: Quadrivalent influenza vaccine (IIV4)
Pharmaceutical form: suspension for injection Route of administration: intramuscular
Other Names:
  • Fluarix Tetra / Fluarix® Quadrivalent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
GMTs of Influenza Vaccine Antibodies at Day 1
Time Frame: Pre-vaccination on 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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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
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.
From the first vaccination up to 6 months after the last vaccination, 209 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi Pasteur, a Sanofi Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Sciences & Operations, Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VAP00026 (Other Identifier: Sanofi Identifier)
  • U1111-1256-8841 (Registry Identifier: ICTRP)
  • 2022-000576-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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