Influenza ImmunisationPhase 1FBP00004NCT04451954
Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects
A Phase 1 study testing Quadrivalent RIV with H3 strain 1, Quadrivalent RIV with H3 strain 1 and adjuvant and Quadrivalent RIV with H3 strain 2 in people with Influenza Immunisation and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 5 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Immunisation, Healthy Volunteers
- What is being tested?
- Quadrivalent RIV with H3 strain 1, Quadrivalent RIV with H3 strain 1 and adjuvant and Quadrivalent RIV with H3 strain 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Jul 2020to 20 Sep 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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 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
Show all 28Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Investigational Site Number 8400002
Melbourne, Florida, 32934
Investigational Site Number 8400004
Orlando, Florida, 32806
Investigational Site Number 8400001
Peoria, Illinois, 61614
Investigational Site Number 8400005
Rockville, Maryland, 20850
Investigational Site Number 8400003
San Diego, California, 92108
About this study
Official title: 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.
Read more
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.
Read the detailed description
Study duration per participant is approximately 1 year
- Conditions
- Influenza Immunisation, Healthy Volunteers
- Being tested
- Quadrivalent RIV with H3 strain 1, Quadrivalent RIV with H3 strain 1 and adjuvant, Quadrivalent RIV with H3 strain 2, Quadrivalent RIV with H3 strain 2 and adjuvant, 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: Suspension for injection Route of administration: Intramuscular
Quadrivalent RIV with H3 strain 1 and adjuvantBiological
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Quadrivalent RIV with H3 strain 2Biological
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Quadrivalent RIV with H3 strain 2 and adjuvantBiological
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Quadrivalent RIV with 2018-2019 NH H3 strainBiological
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvantBiological
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Quadrivalent RIV with H3 strain 1, without adjuvant | Experimental | 1 injection of quadrivalent RIV containing H3 strain 1, without adjuvant, in participants ≥ 50 years old Receives: Biological: Quadrivalent RIV with H3 strain 1 |
| Group 2: Quadrivalent RIV with H3 strain 1, with adjuvant | Experimental | 1 injection of quadrivalent RIV containing H3 strain 1, with adjuvant, in participants ≥ 50 years old Receives: Biological: Quadrivalent RIV with H3 strain 1 and adjuvant |
| Group 3: Quadrivalent RIV with H3 strain 2, without adjuvant | Experimental | 1 injection of quadrivalent RIV containing H3 strain 2, without adjuvant, in participants ≥ 50 years old Receives: Biological: Quadrivalent RIV with H3 strain 2 |
| Group 4: Quadrivalent RIV with H3 strain 2, with adjuvant | Experimental | 1 injection of quadrivalent RIV containing H3 strain 2, with adjuvant, in participants ≥ 50 years old Receives: Biological: Quadrivalent RIV with H3 strain 2 and adjuvant |
| Group 5: Quadrivalent RIV Control, without adjuvant | Active comparator | 1 injection of quadrivalent RIV containing 2018-19 Northern Hemisphere (NH) recommended H3 strain, without adjuvant, in participants ≥ 50 years old Receives: Biological: Quadrivalent RIV with 2018-2019 NH H3 strain |
| Group 6: Quadrivalent RIV Control, with adjuvant | Active comparator | 1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, with adjuvant, in participants ≥ 50 years old Receives: Biological: Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant |
| Group 7: Quadrivalent RIV Control, without adjuvant | Active comparator | 1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, without adjuvant, in participants 18-30 years old 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.
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
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
Number of participants with unsolicited adverse events
Unsolicited (spontaneously reported) adverse events not not fulfilling criteria for solicited reactions
Measured: From Day 0 to Day 28
Number of participants with serious adverse events
Serious adverse events are collected throughout the study
Measured: From Day 0 to Day 365
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 365
Clinical safety laboratory test results
Laboratory tests include complete blood count (CBC), platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, serum creatinine, serum lipase, and serum amylase)
Measured: From Day 0 to Day 7
HAI and SN antibody titers against influenza antigens in the quadrivalent RIV control vaccine
Influenza antibody titers are measured by HAI and SN assays
Measured: From Day 0 to Day 365
Individual HAI and SN titers ratio against influenza antigens in the quadrivalent RIV control vaccine
Titers ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, and Day 90/Day 0
Measured: From Day 0 to Day 90
Number of participants with seroconversion to influenza antigens in the quadrivalent RIV control vaccine
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: From Day 0 to Day 28
HAI Ab titer ≥ 40 [1/dil]
Influenza vaccine antibody titers are measured by HAI assay
Measured: From Day 0 to Day 365
2-fold and 4-fold increase in SN titers
Influenza vaccine antibody titers are measured by SN assay
Measured: From Day 0 to Day 28
Secondary outcomes (4)
HAI antibody titers against influenza H3 antigens not present in the vaccine formulations and the SN antibody titers against each of the H3 antigens
Influenza vaccine antibody titers are measured by HAI and SN assays
Measured: 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
Titer ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, Day 90/Day 0
Measured: From Day 0 to Day 90
Number of participants with seroconversion to influenza H3 antigens not present in the vaccine formulations
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 0 and Day 28
2-fold and 4-fold rise in SN antibody titers against each of the H3 antigens
Influenza vaccine antibody titers a are measured by SN assay
Measured: Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start2 Jul 2020
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza ImmunisationStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 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
- NCT04451954
- Sponsor's protocol ID
- FBP00004
- Other IDs
- U1111-1239-0391
- Acronym
- FBP00004
- Status last verified
- Sep 2025
- First submitted
- 25 Jun 2020
- Last updated
- 17 Sep 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens Without or With Adjuvant in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04451954
- Acronym / sponsor ID
- FBP00004 / FBP00004
- Conditions
- Influenza Immunisation, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study duration per participant is approximately 1 year
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1: Quadrivalent RIV with H3 strain 1, without adjuvant | Experimental | Biological: Quadrivalent RIV with H3 strain 11 injection of quadrivalent RIV containing H3 strain 1, without adjuvant, in participants ≥ 50 years old |
| Group 2: Quadrivalent RIV with H3 strain 1, with adjuvant | Experimental | Biological: Quadrivalent RIV with H3 strain 1 and adjuvant1 injection of quadrivalent RIV containing H3 strain 1, with adjuvant, in participants ≥ 50 years old |
| Group 3: Quadrivalent RIV with H3 strain 2, without adjuvant | Experimental | Biological: Quadrivalent RIV with H3 strain 21 injection of quadrivalent RIV containing H3 strain 2, without adjuvant, in participants ≥ 50 years old |
| Group 4: Quadrivalent RIV with H3 strain 2, with adjuvant | Experimental | Biological: Quadrivalent RIV with H3 strain 2 and adjuvant1 injection of quadrivalent RIV containing H3 strain 2, with adjuvant, in participants ≥ 50 years old |
| Group 5: Quadrivalent RIV Control, without adjuvant | Active comparator | Biological: Quadrivalent RIV with 2018-2019 NH H3 strain1 injection of quadrivalent RIV containing 2018-19 Northern Hemisphere (NH) recommended H3 strain, without adjuvant, in participants ≥ 50 years old |
| Group 6: Quadrivalent RIV Control, with adjuvant | Active comparator | Biological: Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, with adjuvant, in participants ≥ 50 years old |
| Group 7: Quadrivalent RIV Control, without adjuvant | Active comparator | Biological: Quadrivalent RIV with 2018-2019 NH H3 strain1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, without adjuvant, in participants 18-30 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (28 listed)
- 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
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 RIV with H3 strain 1Pharmaceutical form: Suspension for injection Route of administration: Intramuscular | Biological | Group 1: Quadrivalent RIV with H3 strain 1, without adjuvant |
| Quadrivalent RIV with H3 strain 1 and adjuvantPharmaceutical form: Suspension for injection Route of administration: Intramuscular | Biological | Group 2: Quadrivalent RIV with H3 strain 1, with adjuvant |
| Quadrivalent RIV with H3 strain 2Pharmaceutical form: Suspension for injection Route of administration: Intramuscular | Biological | Group 3: Quadrivalent RIV with H3 strain 2, without adjuvant |
| Quadrivalent RIV with H3 strain 2 and adjuvantPharmaceutical form: Suspension for injection Route of administration: Intramuscular | Biological | Group 4: Quadrivalent RIV with H3 strain 2, with adjuvant |
| Quadrivalent RIV with 2018-2019 NH H3 strainPharmaceutical form: Suspension for injection Route of administration: Intramuscular | Biological | Group 5: Quadrivalent RIV Control, without adjuvant, Group 7: Quadrivalent RIV Control, without adjuvant |
| Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvantPharmaceutical form: Suspension for injection Route of administration: Intramuscular | Biological | Group 6: Quadrivalent RIV Control, with adjuvant |
Primary outcome
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
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
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
Number of participants with serious adverse events
Time frame: From Day 0 to Day 365
Serious adverse events are collected throughout the study
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
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)
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
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
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)
HAI Ab titer ≥ 40 [1/dil]
Time frame: From Day 0 to Day 365
Influenza vaccine antibody titers are measured by HAI assay
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
4 secondary outcomes
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
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
Number of participants with seroconversion to influenza H3 antigens not present in the vaccine formulations
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- FBP00004 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
5 sites in 1 country: see every site and its status.
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 1 and adjuvant and Quadrivalent RIV with H3 strain 2 in people with Influenza Immunisation and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 5 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 28 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 17 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 5 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 11 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 17 Sep 2025.