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InfluenzaPhase 1FBP00001NCT04144179

Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens in Healthy Adult Subjects 18 to 30 Years of Age

A Phase 1 study testing Quadrivalent RIV with H3 strain 1, Quadrivalent RIV with H3 strain 2 and Quadrivalent RIV with H3 strain 3 in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 3 sites in United States.

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 primary objectives of the study are: To describe the safety profile of the different quadrivalent recombinant influenza vaccine (RIV) formulations. To describe the hemagglutination inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (HA) (H1, H3, B/Victoria, and B/Yamagata)… Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Quadrivalent RIV with H3 strain 1, Quadrivalent RIV with H3 strain 2 and Quadrivalent RIV with H3 strain 3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
3 sitesUnited States
Study dates
6 Nov 2019to 24 Feb 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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 study procedures

Who cannot join

  • 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 after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal 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 in the previous influenza season (2018-2019) with any licensed or investigational influenza vaccine
  • Previous vaccination against influenza in the 2019-2020 season with any licensed influenza vaccine
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
Show all 24Show fewer
  • 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)
  • Have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy
  • History of influenza infection during the 2018-2019 or 2019-2020 influenza season, confirmed by laboratory tests (including rapid tests)
  • 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
  • Thrombocytopenia or bleeding disorder, contraindicating intramuscular vaccination based on Investigator's judgement
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • 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 or predispose to complications associated with influenza infection
  • Have any diagnosis, current or past, of chronic pulmonary diseases including asthma, cystic fibrosis and chronic pulmonary obstructive disease
  • Have taken high-dose inhaled corticosteroids within 6 months prior to study vaccination
  • Body Mass Index of 40 or higher
  • History of cardiac disease such as congenital heart disease, heart failure, coronary artery disease (except isolated hypertension)
  • Health care personnel in inpatient and outpatient care settings, medical emergency-response workers, employees of nursing home and long-term care facilities who have contact with patients or residents and students in these professions who will have contact with patients
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (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
  • 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

3 sites in 1 country.

United States3 sites

  • Research Centers of America Site Number : 8400002

    Hollywood, Florida, 33024

  • Coastal Carolina Research Center Site Number : 8400003

    North Charleston, South Carolina, 29405

  • Rochester Clinical Research, Inc. Site Number : 8400001

    Rochester, New York, 14609

Other trials in United States

About this study

The primary objectives of the study are:

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

The secondary objectives of the study 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 HAI and SN antibody responses in each group against each of the H3 antigens.
  • To compare the HAI and SN antibody responses for the groups with different H3 antigens to the control group.
Read the detailed description

Study duration per participant is approximately 90 days.

Conditions
Influenza
Being tested
Quadrivalent RIV with H3 strain 1, Quadrivalent RIV with H3 strain 2, Quadrivalent RIV with H3 strain 3, Quadrivalent RIV with H3 strain 4, Quadrivalent RIV with 2018-2019 NH H3 strain
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 RIV with H3 strain 1Biological

    Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular

  • Quadrivalent RIV with H3 strain 2Biological

    Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular

  • Quadrivalent RIV with H3 strain 3Biological

    Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular

  • Quadrivalent RIV with H3 strain 4Biological

    Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular

  • Quadrivalent RIV with 2018-2019 NH H3 strainBiological

    Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular

Study groups in NCT04144179
Study groupRoleWhat they receive
Quadrivalent RIV with H3 strain 1Experimental1 injection of Quadrivalent RIV containing H3 strain 1
Receives: Biological: Quadrivalent RIV with H3 strain 1
Quadrivalent RIV with H3 strain 2Experimental1 injection of Quadrivalent RIV containing H3 strain 2
Receives: Biological: Quadrivalent RIV with H3 strain 2
Quadrivalent RIV with H3 strain 3Experimental1 injection of Quadrivalent RIV containing H3 strain 3
Receives: Biological: Quadrivalent RIV with H3 strain 3
Quadrivalent RIV with H3 strain 4Experimental1 injection of Quadrivalent RIV containing H3 strain 4
Receives: Biological: Quadrivalent RIV with H3 strain 4
Quadrivalent RIV ControlActive comparator1 injection of Quadrivalent RIV containing 2018-19 NH recommended H3 strain
Receives: Biological: Quadrivalent RIV with 2018-2019 NH H3 strain

What is being measured

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

  1. Number of participants with immediate adverse events

    Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination

    Measured: Within 30 minutes after vaccination

  2. Number of participants with solicited injection site or systemic reactions

    Solicited injection site reactions: injection site pain, erythema, swelling, induration and bruising; solicited systemic reactions: fever, headache, malaise, and myalgia

    Measured: From Day 0 to Day 7

  3. Number of participants with unsolicited adverse events

    Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited reactions

    Measured: From Day 0 to Day 28

  4. Number of participants with serious adverse events

    Serious adverse events are collected throughout the study

    Measured: From Day 0 to Day 90

  5. Number of participants with adverse events of special interest

    Adverse events of special interest are collected throughout the study

    Measured: From Day 0 to Day 90

  6. HAI antibody titers against HA influenza antigens in quadrivalent RIV control group

    Influenza vaccine antigens are measured by HAI assay

    Measured: From Day 0 to Day 90

  7. Individual ratio of HAI titers against HA influenza antigens in quadrivalent RIV control group

    Titers ratio are calculated for Day 8/Day 0 and Day 28/Day 0, Day 56/Day 28 and Day 90/Day 28

    Measured: From Day 0 to Day 90

  8. Number of participants with seroconversion to HA influenza antigens in quadrivalent RIV control group

    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

    Measured: Day 28

  9. Number of participants with HAI antibody titer ≥ 40 [1/dil] against HA influenza antigens in quadrivalent RIV control group

    Influenza vaccine antigens are measured by HAI assay

    Measured: From Day 0 to Day 90

Secondary outcomes (6)

  1. 2-fold and 4-fold increase in SN antibody titers against HA influenza antigens in quadrivalent RIV control group

    Measured: From Day 0 to Day 90

  2. HAI and SN antibody titers against influenza H3 antigens

    Measured: From Day 0 to Day 90

  3. Individual ratio of HAI and SN titers against influenza H3 antigens

    Titers ratio are calculated for Day 8/Day 0 and Day 28/Day 0, Day 56/Day 28 and Day 90/Day 28

    Measured: From Day 0 to Day 90

  4. Number of participants with seroconversion to influenza H3 antigens

    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

    Measured: Day 28

  5. Number of participants with HAI antibody titer ≥ 40 [1/dil] against influenza H3 antigens

    Measured: From Day 0 to Day 90

  6. 2-fold and 4-fold increase in SN antibody titers against influenza H3 antigens

    Measured: From Day 0 to Day 90

Timeline

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

  1. First posted30 Oct 2019
  2. Study start6 Nov 2019
  3. Primary completion24 Feb 2020
  4. Study completion24 Feb 2020

Resources

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04144179
Sponsor's protocol ID
FBP00001
Other IDs
U1111-1223-4988, FBP00001
Acronym
FBP00001
Status last verified
Jul 2025
First submitted
28 Oct 2019
Last updated
29 Jul 2025
Results posted
No
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Quadrivalent RIV with H3 strain 1, Quadrivalent RIV with H3 strain 2 and Quadrivalent RIV with H3 strain 3 in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 3 sites in United States.

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 24 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 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with immediate adverse events (time frame: Within 30 minutes after vaccination). The study lists 9 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 NCT04144179.

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 29 Jul 2025.

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