Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects (FBP00004)

September 11, 2025 updated by: Sanofi Pasteur, a Sanofi Company

Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens Without or With Adjuvant in Healthy Adult Subjects

The primary objectives of the study are:

  • To describe the safety profile of the different formulations in all participants
  • To describe the hemagglutinin inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints.

The secondary objectives are:

  • To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations).
  • To describe SN antibody responses in each group against each of the H3 antigens.
  • To compare H3 HAI and SN antibody responses for the groups with quadrivalent recombinant influenza vaccine (RIV) formulations with H3 antigens to those of the quadrivalent RIV control group.
  • To compare the HAI and SN antibody responses for the groups with quadrivalent RIV formulation with adjuvant to the group without adjuvant.

Study Overview

Status

Status

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

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

Study duration per participant is approximately 1 year

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.
210

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 1

Contacts and Locations

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

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92108
        • Investigational Site Number 8400003
    • Florida
      • Melbourne, Florida, United States, 32934
        • Investigational Site Number 8400002
      • Orlando, Florida, United States, 32806
        • Investigational Site Number 8400004
    • Illinois
      • Peoria, Illinois, United States, 61614
        • Investigational Site Number 8400001
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Investigational Site Number 8400005

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria :

  • Older adults: Aged 50 years and older on the day of inclusion Young adults: Aged 18 to 30 years on the day of inclusion
  • Informed consent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures

Exclusion criteria:

  • Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 12 weeks postvaccination. To be considered of non-childbearing potential, a female must be premenarche, or postmenopausal for at least 1 year, or surgically sterile
  • Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following study vaccination
  • Previous vaccination against influenza during either of the previous 2 influenza seasons (2018-2019 and 2019-2020) with any licensed or investigational influenza vaccine
  • Receipt of immune globulins, blood, or blood-derived products in the past 3 months
  • Known or suspected congenital or acquired immunodeficiency; immunosuppressive therapy (such as anticancer 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) or receipt of hydroxychloroquine within the preceding 4 weeks
  • Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures
  • Have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy
  • History of influenza infection during either of the previous 2 influenza seasons (2018- 2019 or 2019-2020), confirmed by laboratory tests (including rapid tests) at that time
  • History of laboratory confirmed coronavirus disease 2019 (COVID-19), confirmed with a nucleic acid amplification test on a respiratory specimen, or known exposure to severe acute respiratory syndrome coronavirus (SARS-CoV-2) positive confirmed close contact (eg, family member, housemate, daycare provider, aged parent requiring care), in the 30 days preceding vaccination, at the discretion of the investigator
  • Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C
  • Known systemic 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
  • Have any diagnosis, current or past, of an autoimmune disease
  • Thrombocytopenia or bleeding disorder, contraindicating intramuscular vaccination based on investigator's judgment
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Any change in chronic prescription medication or change in medication dose or dosage in the 60 days prior to enrollment
  • Alcohol abuse or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • Any current or past diagnosis of chronic pulmonary disease including asthma (history of childhood asthma is allowed), cystic fibrosis and chronic pulmonary obstructive disease
  • Have taken a high-dose inhaled corticosteroid within 6 months prior to study vaccination
  • Body mass index of 40 or higher
  • Any current or past diagnosis of cardiac disease (eg, coronary artery disease, heart failure, or valvular heart disease [mild mitral valve prolapse allowed]). Participants with isolated primary (essential) hypertension are allowed
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (oral temperature ≥100.4 F [≥38.0 C]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
  • Identified as an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study
  • Personal or family history of Guillain-Barré syndrome
  • History of chronic kidney disease
  • Current or past diagnosis of thyroid disease (eg, thyroiditis [including Hashimoto's thyroiditis], hyperthyroidism, and hypothyroidism)

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: Quadruple

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: Group 1: Quadrivalent RIV with H3 strain 1, without adjuvant
1 injection of quadrivalent RIV containing H3 strain 1, without adjuvant, in participants ≥ 50 years old
Biological: Quadrivalent RIV with H3 strain 1
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Experimental: Group 2: Quadrivalent RIV with H3 strain 1, with adjuvant
1 injection of quadrivalent RIV containing H3 strain 1, with adjuvant, in participants ≥ 50 years old
Biological: Quadrivalent RIV with H3 strain 1 and adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Experimental: Group 3: Quadrivalent RIV with H3 strain 2, without adjuvant
1 injection of quadrivalent RIV containing H3 strain 2, without adjuvant, in participants ≥ 50 years old
Biological: Quadrivalent RIV with H3 strain 2
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Experimental: Group 4: Quadrivalent RIV with H3 strain 2, with adjuvant
1 injection of quadrivalent RIV containing H3 strain 2, with adjuvant, in participants ≥ 50 years old
Biological: Quadrivalent RIV with H3 strain 2 and adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Active Comparator: Group 5: Quadrivalent RIV Control, without adjuvant
1 injection of quadrivalent RIV containing 2018-19 Northern Hemisphere (NH) recommended H3 strain, without adjuvant, in participants ≥ 50 years old
Biological: Quadrivalent RIV with 2018-2019 NH H3 strain
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Active Comparator: Group 6: Quadrivalent RIV Control, with adjuvant
1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, with adjuvant, in participants ≥ 50 years old
Biological: Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Active Comparator: Group 7: Quadrivalent RIV Control, without adjuvant
1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, without adjuvant, in participants 18-30 years old
Biological: Quadrivalent RIV with 2018-2019 NH H3 strain
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

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
Number of participants with immediate adverse events
Time Frame: Within 30 minutes after vaccination
Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Within 30 minutes after vaccination
Number of participants with solicited injection site or systemic reactions
Time Frame: From Day 0 to Day 7
Solicited injection site reactions: injection site pain, erythema, swelling, induration and bruising; solicited systemic reactions: fever, headache, malaise, and myalgia
From Day 0 to Day 7
Number of participants with unsolicited adverse events
Time Frame: From Day 0 to Day 28
Unsolicited (spontaneously reported) adverse events not not fulfilling criteria for solicited reactions
From Day 0 to Day 28
Number of participants with serious adverse events
Time Frame: From Day 0 to Day 365
Serious adverse events are collected throughout the study
From Day 0 to Day 365
Number of participants with adverse events of special interest
Time Frame: From Day 0 to Day 365
Adverse events of special interest are collected throughout the study
From Day 0 to Day 365
Clinical safety laboratory test results
Time Frame: From Day 0 to Day 7
Laboratory tests include complete blood count (CBC), platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, serum creatinine, serum lipase, and serum amylase)
From Day 0 to Day 7
HAI and SN antibody titers against influenza antigens in the quadrivalent RIV control vaccine
Time Frame: From Day 0 to Day 365
Influenza antibody titers are measured by HAI and SN assays
From Day 0 to Day 365
Individual HAI and SN titers ratio against influenza antigens in the quadrivalent RIV control vaccine
Time Frame: From Day 0 to Day 90
Titers ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, and Day 90/Day 0
From Day 0 to Day 90
Number of participants with seroconversion to influenza antigens in the quadrivalent RIV control vaccine
Time Frame: From Day 0 to Day 28
Seroconversion is defined as HAI antibody titer < 10 [1/dil] at Day 0 and post-injection titer ≥ 40 [1/dil] at Day 28, or titer ≥ 10 [1/dil] at Day 0 and a ≥ 4-fold increase in titer [1/dil] at Day 28)
From Day 0 to Day 28
HAI Ab titer ≥ 40 [1/dil]
Time Frame: From Day 0 to Day 365
Influenza vaccine antibody titers are measured by HAI assay
From Day 0 to Day 365
2-fold and 4-fold increase in SN titers
Time Frame: From Day 0 to Day 28
Influenza vaccine antibody titers are measured by SN assay
From Day 0 to Day 28

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
HAI antibody titers against influenza H3 antigens not present in the vaccine formulations and the SN antibody titers against each of the H3 antigens
Time Frame: Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365
Influenza vaccine antibody titers are measured by HAI and SN assays
Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365
Individual HAI titer ratios against influenza H3 antigens not present in the vaccine formulations and individual SN titer ratio against each of the H3 antigens
Time Frame: From Day 0 to Day 90
Titer ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, Day 90/Day 0
From Day 0 to Day 90
Number of participants with seroconversion to influenza H3 antigens not present in the vaccine formulations
Time Frame: Day 0 and Day 28
Seroconversion is defined as HAI antibody titer < 10 [1/dil] at Day 0 and post-injection titer ≥ 40 [1/dil] at Day 28, or titer ≥ 10 [1/dil] at Day 0 and a ≥ 4-fold increase in titer [1/dil] at Day 28)
Day 0 and Day 28
2-fold and 4-fold rise in SN antibody titers against each of the H3 antigens
Time Frame: Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365
Influenza vaccine antibody titers a are measured by SN assay
Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365

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.
July 2, 2020

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.
September 20, 2021

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.
September 20, 2021

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).
June 25, 2020

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.
June 25, 2020

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.
June 30, 2020

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 17, 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 11, 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.
  • FBP00004
  • U1111-1239-0391 (Other Identifier: UTN)

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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