InfluenzaPhase 1/2NCT06744205
A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older
A Phase 1/2 study testing Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1, TIV mRNA-neuraminidase (NA) and TIV mRNA-HA Vaccine 2 in people with Influenza and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 24 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose levels of trivalent (TIV) mRNA hemagglutinin (HA) in combination with TIV… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Healthy Volunteers
- What is being tested?
- Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1, TIV mRNA-neuraminidase (NA) and TIV mRNA-HA Vaccine 2
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,162 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 6 Jan 2025to 22 May 2026
- Phase
- Phase 1/2
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant aged 50 years on the day of inclusion
- A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.
- OR
- Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.
- A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours prior to administration of study intervention.
Who cannot join
- Participants are not eligible for the study if any of the following criteria are met:
- 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 study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA vaccine
- Previous history of myocarditis, pericarditis, and/or myopericarditis
- Known history of previous episodes of Guillain-Barré syndrome, neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis
- Participants with an electrocardiogram that is consistent with possible myocarditis or pericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
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- Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator's judgment
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination based on Investigator's judgment
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
- Moderate or severe acute illness / infection (according to investigator's judgement) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
- Participant who had acute infectious symptoms or a positive SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to the first visit (V01)
- Receipt of any vaccine in the 4 weeks preceding study intervention administration or planned receipt of any vaccine in the 4 weeks following study intervention administration
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine
- Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration or planned receipt of any mRNA vaccine in the 2 months after study vaccination
- Participation at the time of study enrollment (or in the 4 weeks preceding study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States21 sites
Accel Research Sites Network - Birmingham- Site Number : 8400008
Birmingham, Alabama, 35216
Boston Clinical Trials- Site Number : 8400009
Boston, Massachusetts, 02131
Charlottesville Medical Research- Site Number : 8400004
Charlottesville, Virginia, 22911
AMR Miami- Site Number : 8400021
Coral Gables, Florida, 33134
Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400001
Decatur, Georgia, 30030-2627
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400003
DeLand, Florida, 32720
Quest Research Institute- Site Number : 8400010
Farmington Hills, Michigan, 48334
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400013
Fort Myers, Florida, 33912
Alliance for Multispeciality Research - Kansas City- Site Number : 8400019
Kansas City, Missouri, 64114
Alliance for Multispeciality Research - Knoxville- Site Number : 8400017
Knoxville, Tennessee, 37920
AMR Las Vegas - Site Number : 8400016
Las Vegas, Nevada, 89119
Alliance for Multispeciality Research - Lexington- Site Number : 8400018
Lexington, Kentucky, 40509
Accel Research Sites - Maitland- Site Number : 8400007
Maitland, Florida, 32751
ActivMed Practices & Research- Site Number : 8400005
Methuen, Massachusetts, 03110
AMR Mobile- Site Number : 8400022
Mobile, Alabama, 36608
Alliance for Multispeciality Research - Newton- Site Number : 8400020
Newton, Kansas, 67114
Coastal Carolina Research Center - North Charleston- Site Number : 8400002
North Charleston, South Carolina, 29405
AMR - Chicago- Site Number : 8400012
Oak Brook, Illinois, 60532
Innovation Medical Research Center - Palmetto Bay- Site Number : 8400011
Palmetto Bay, Florida, 33157
Alliance for Multispeciality Research - Clinical Research Consortium- Site Number : 8400015
Tempe, Arizona, 85281
Alliance for Multispeciality Research - Wichita East- Site Number : 8400014
Wichita, Kansas, 67207
Australia3 sites
Investigational Site Number : 0360003
Bayswater, Victoria, 3153
Investigational Site Number : 0360001
Botany, New South Wales, 2019
Investigational Site Number : 0360002
Melbourne, Victoria, 3124
About this study
Official title: A Phase I/II, Randomized, Modified Double-blind Study to Investigate the Safety and Immunogenicity of Different Doses of Hexavalent Influenza mRNA HA + mRNA NA Vaccine in Adult Participants 50 Years of Age and Older
The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose levels of trivalent (TIV) mRNA hemagglutinin (HA) in combination with TIV mRNA-neuraminidase (NA) compared to an active control ((Fluzone standard-dose quadrivalent influenza vaccine (QIV-SD) or Fluzone high-dose quadrivalent influenza vaccine (QIV-HD) in adults 50 years of age and older.
Read the detailed description
Study details include the following:
- Study Duration: approximately 12 months for each participant
- Treatment: 1 injection of hexavalent vaccine, trivalent vaccine, or active control
- Visit frequency: Day (D) 01, D03, D09, D29, and D181; D366 (telephone call)
- Dose escalation with sequential enrollment of sentinel cohorts followed by parallel enrollment of the main cohort
- Conditions
- Influenza, Healthy Volunteers
- Being tested
- Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1, TIV mRNA-neuraminidase (NA), TIV mRNA-HA Vaccine 2, Quadrivalent Influenza Standard Dose Vaccine, Quadrivalent Influenza Vaccine High Dose
- Keywords
- influenza, flu, vaccine, hexavalent
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1Biological
- Pharmaceutical form: solution for injection in a vial
- Route of administration: Intramuscular injection
TIV mRNA-neuraminidase (NA)Biological
- Pharmaceutical form: solution for injection in a vial
- Route of administration: Intramuscular injection
TIV mRNA-HA Vaccine 2Biological
- Pharmaceutical form: solution for injection in a vial
- Route of administration: Intramuscular injection
Quadrivalent Influenza Standard Dose VaccineBiological
Also called Fluzone Qudrivalent®
- Pharmaceutical form: Liquid suspension for injection in pre-filled syringe
- Route of administration: Intramuscular injection
Quadrivalent Influenza Vaccine High DoseBiological
Also called Fluzone High-Dose Quadrivalent®
- Pharmaceutical form: Liquid suspension for injection in pre-filled syringe
- Route of administration: Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Hexavalent (Combination 1) | Experimental | Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 1) Receives: Biological: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1; Biological: TIV mRNA-neuraminidase (NA) |
| Group 2 - Hexavalent (Combination 2) | Experimental | Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 2) Receives: Biological: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1; Biological: TIV mRNA-neuraminidase (NA) |
| Group 3 - Hexavalent (Combination 3) | Experimental | Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 3) Receives: Biological: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1; Biological: TIV mRNA-neuraminidase (NA) |
| Group 4 - Hexavalent (Combination 4) | Experimental | Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 4) Receives: Biological: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1; Biological: TIV mRNA-neuraminidase (NA) |
| Group 5 - Hexavalent (Combination 5) | Experimental | Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 5) Receives: Biological: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1; Biological: TIV mRNA-neuraminidase (NA) |
| Group 6 - Hexavalent (Combination 6) | Experimental | Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 6) Receives: Biological: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1; Biological: TIV mRNA-neuraminidase (NA) |
| Group 7 - TIV mRNA-HA Vaccine 1 | Experimental | Participants will receive a single dose of TIV mRNA-HA Vaccine 1 Receives: Biological: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1 |
| Group 8 - TIV mRNA-NA | Experimental | Participants will receive a single dose of TIV mRNA-NA Receives: Biological: TIV mRNA-neuraminidase (NA) |
| Group 9 - TIV mRNA-HA Vaccine 2 | Experimental | Participants will receive single dose of TIV mRNA-HA Vaccine 2 Receives: Biological: TIV mRNA-HA Vaccine 2 |
| Group 10 - QIV-SD | Active comparator | Participants will receive single dose of QIV-SD vaccine (for participants 50 to 64 years of age only) Receives: Biological: Quadrivalent Influenza Standard Dose Vaccine |
| Group 11 - QIV-HD | Active comparator | Participants will receive single dose of QIV-HD vaccine Receives: Biological: Quadrivalent Influenza Vaccine High Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with immediate unsolicited systemic adverse events (AEs)
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Measured: Within 30 minutes after injection
Number of participants with solicited injection site reactions
Solicited injection site reactions pre-listed in the participant diary and in the case report form CRF
Measured: Up to 7 days after injection
Number of participants with solicited systemic reactions
Solicited systemic reactions pre-listed in the participant diary and in the CRF
Measured: Up to 7 days after injection
Number of participants with unsolicited AEs
AEs that do not fulfill the conditions of solicited reactions
Measured: Up to 28 days after injection
Number of participants with medically attended adverse events (MAAEs)
MAAEs reported up to 180 days after injection
Measured: Up to 180 days after injection
Number of participants with serious adverse events (SAEs)
Throughout the study
Measured: SAEs throughout the study (Up to approximately 12 months)
Number of participants with adverse events of special interest (AESIs)
Throughout the study
Measured: AESIs throughout the study (Up to approximately 12 months)
Number of participants with out-of-range biological test results
Out-of-range biological test results (including shift from baseline values)
Measured: Up to 8 days after injection
Hemagglutinin inhibition (HAI) titers
HAI titers at D01 and D29
Measured: At Day 1 and Day 29
Individual HAI antibody (Ab) titer ratio D29/D01
Individual HAI Ab titer ratio D29/D01
Measured: At Day 1 and Day 29
Seroconversion (HAI Ab titer)
Number of participants with HAI Ab titer < 10 [1/dil] at Day 1 and post-injection titer ≥ 40 [1/dil] at Day 29, or titer ≥ 10 [1/dil] at Day 1 and a ≥ 4-fold increase in titer [1/dil] at Day 29
Measured: At Day 1 and Day 29
HAI Ab titer ≥ 40 (1/dil)
HAI Ab titer ≥ 40 (1/dil) at D29
Measured: At Day 29
Neuraminidase inhibition (NAI) titers
NAI titers at D01 and D29
Measured: At Day 1 and Day 29
Individual NAI Ab titer ratio D29/D01
Individual NAI Ab titer ratio D29/D01
Measured: At Day 1 and Day 29
Seroconversion (NAI Ab titer)
Number of participants with NAI Ab titer < 10 [1/dil] at D01 and post-injection titer ≥ 40 [1/dil] at D29, or titer ≥ 10 [1/dil] at D01 and a ≥ 4-fold increase in titer [1/dil] at D29)
Measured: At Day 1 and Day 29
NAI Ab titer ≥ 40 (1/dil)
NAI Ab titer ≥ 40 (1/dil) at D29
Measured: At Day 29
2-fold and 4-fold rise in NAI titers
2-fold and 4-fold rise in NAI titers from D01 to D29
Measured: Day 1 to Day 29
Secondary outcomes (3)
Neutralizing antibodies titers
Neutralizing antibodies titers at D01 and D29
Measured: At Day 1 and Day 29
Individual neutralizing antibodies titer ratio
Individual neutralizing antibodies titer ratio D29/D01
Measured: At Day 1 and Day 29
2-fold and 4-fold increase in neutralizing titers
2-fold and 4-fold increase in neutralizing titers D01 through D29
Measured: Day 1 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start6 Jan 2025
- Primary completion22 May 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dose escalation with sequential enrollment of sentinel cohorts followed by parallel enrollment of the main cohort.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,162 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744205
- Sponsor's protocol ID
- FBP00021
- Other IDs
- U1111-1303-3537
- Status last verified
- Jun 2026
- First submitted
- 16 Dec 2024
- Last updated
- 9 Jun 2026
- 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomized, Modified Double-blind Study to Investigate the Safety and Immunogenicity of Different Doses of Hexavalent Influenza mRNA HA + mRNA NA Vaccine in Adult Participants 50 Years of Age and Older
- ClinicalTrials.gov ID
- NCT06744205
- Acronym / sponsor ID
- FBP00021
- Conditions
- Influenza, Healthy Volunteers
- Keywords
- influenza, flu, vaccine, hexavalent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,162 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 20 Dec 2024 (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 purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose levels of trivalent (TIV) mRNA hemagglutinin (HA) in combination with TIV mRNA-neuraminidase (NA) compared to an active control ((Fluzone standard-dose quadrivalent influenza vaccine (QIV-SD) or Fluzone high-dose quadrivalent influenza vaccine (QIV-HD) in adults 50 years of age and older.
Detailed description
Study details include the following:
- Study Duration: approximately 12 months for each participant
- Treatment: 1 injection of hexavalent vaccine, trivalent vaccine, or active control
- Visit frequency: Day (D) 01, D03, D09, D29, and D181; D366 (telephone call)
- Dose escalation with sequential enrollment of sentinel cohorts followed by parallel enrollment of the main cohort
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
- Model description
- Dose escalation with sequential enrollment of sentinel cohorts followed by parallel enrollment of the main cohort.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Hexavalent (Combination 1) | Experimental | Biological: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1, Biological: TIV mRNA-neuraminidase (NA)Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 1) |
| Group 2 - Hexavalent (Combination 2) | Experimental | Biological: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1, Biological: TIV mRNA-neuraminidase (NA)Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 2) |
| Group 3 - Hexavalent (Combination 3) | Experimental | Biological: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1, Biological: TIV mRNA-neuraminidase (NA)Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 3) |
| Group 4 - Hexavalent (Combination 4) | Experimental | Biological: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1, Biological: TIV mRNA-neuraminidase (NA)Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 4) |
| Group 5 - Hexavalent (Combination 5) | Experimental | Biological: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1, Biological: TIV mRNA-neuraminidase (NA)Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 5) |
| Group 6 - Hexavalent (Combination 6) | Experimental | Biological: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1, Biological: TIV mRNA-neuraminidase (NA)Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 6) |
| Group 7 - TIV mRNA-HA Vaccine 1 | Experimental | Biological: Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1Participants will receive a single dose of TIV mRNA-HA Vaccine 1 |
| Group 8 - TIV mRNA-NA | Experimental | Biological: TIV mRNA-neuraminidase (NA)Participants will receive a single dose of TIV mRNA-NA |
| Group 9 - TIV mRNA-HA Vaccine 2 | Experimental | Biological: TIV mRNA-HA Vaccine 2Participants will receive single dose of TIV mRNA-HA Vaccine 2 |
| Group 10 - QIV-SD | Active comparator | Biological: Quadrivalent Influenza Standard Dose VaccineParticipants will receive single dose of QIV-SD vaccine (for participants 50 to 64 years of age only) |
| Group 11 - QIV-HD | Active comparator | Biological: Quadrivalent Influenza Vaccine High DoseParticipants will receive single dose of QIV-HD vaccine |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant aged 50 years on the day of inclusion
- A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- OR
- Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.
- A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours prior to administration of study intervention.
Key exclusion criteria (18 listed)
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA vaccine
- Previous history of myocarditis, pericarditis, and/or myopericarditis
- Known history of previous episodes of Guillain-Barré syndrome, neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis
- Participants with an electrocardiogram that is consistent with possible myocarditis or pericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
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 |
|---|---|---|
| Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection | Biological | Group 1 - Hexavalent (Combination 1), Group 2 - Hexavalent (Combination 2), Group 3 - Hexavalent (Combination 3), Group 4 - Hexavalent (Combination 4), Group 5 - Hexavalent (Combination 5), Group 6 - Hexavalent (Combination 6), Group 7 - TIV mRNA-HA Vaccine 1 |
| TIV mRNA-neuraminidase (NA)* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection | Biological | Group 1 - Hexavalent (Combination 1), Group 2 - Hexavalent (Combination 2), Group 3 - Hexavalent (Combination 3), Group 4 - Hexavalent (Combination 4), Group 5 - Hexavalent (Combination 5), Group 6 - Hexavalent (Combination 6), Group 8 - TIV mRNA-NA |
| TIV mRNA-HA Vaccine 2* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection | Biological | Group 9 - TIV mRNA-HA Vaccine 2 |
| Quadrivalent Influenza Standard Dose VaccineAlso: Fluzone Qudrivalent®* Pharmaceutical form: Liquid suspension for injection in pre-filled syringe * Route of administration: Intramuscular injection | Biological | Group 10 - QIV-SD |
| Quadrivalent Influenza Vaccine High DoseAlso: Fluzone High-Dose Quadrivalent®* Pharmaceutical form: Liquid suspension for injection in pre-filled syringe * Route of administration: Intramuscular injection | Biological | Group 11 - QIV-HD |
Primary outcome
Number of participants with immediate unsolicited systemic adverse events (AEs)
Time frame: Within 30 minutes after injection
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Number of participants with solicited injection site reactions
Time frame: Up to 7 days after injection
Solicited injection site reactions pre-listed in the participant diary and in the case report form CRF
Number of participants with solicited systemic reactions
Time frame: Up to 7 days after injection
Solicited systemic reactions pre-listed in the participant diary and in the CRF
Number of participants with unsolicited AEs
Time frame: Up to 28 days after injection
AEs that do not fulfill the conditions of solicited reactions
Number of participants with medically attended adverse events (MAAEs)
Time frame: Up to 180 days after injection
MAAEs reported up to 180 days after injection
Number of participants with serious adverse events (SAEs)
Time frame: SAEs throughout the study (Up to approximately 12 months)
Throughout the study
Number of participants with adverse events of special interest (AESIs)
Time frame: AESIs throughout the study (Up to approximately 12 months)
Throughout the study
Number of participants with out-of-range biological test results
Time frame: Up to 8 days after injection
Out-of-range biological test results (including shift from baseline values)
Hemagglutinin inhibition (HAI) titers
Time frame: At Day 1 and Day 29
HAI titers at D01 and D29
Individual HAI antibody (Ab) titer ratio D29/D01
Time frame: At Day 1 and Day 29
Individual HAI Ab titer ratio D29/D01
Seroconversion (HAI Ab titer)
Time frame: At Day 1 and Day 29
Number of participants with HAI Ab titer < 10 [1/dil] at Day 1 and post-injection titer ≥ 40 [1/dil] at Day 29, or titer ≥ 10 [1/dil] at Day 1 and a ≥ 4-fold increase in titer [1/dil] at Day 29
HAI Ab titer ≥ 40 (1/dil)
Time frame: At Day 29
HAI Ab titer ≥ 40 (1/dil) at D29
Neuraminidase inhibition (NAI) titers
Time frame: At Day 1 and Day 29
NAI titers at D01 and D29
Individual NAI Ab titer ratio D29/D01
Time frame: At Day 1 and Day 29
Individual NAI Ab titer ratio D29/D01
Seroconversion (NAI Ab titer)
Time frame: At Day 1 and Day 29
Number of participants with NAI Ab titer < 10 [1/dil] at D01 and post-injection titer ≥ 40 [1/dil] at D29, or titer ≥ 10 [1/dil] at D01 and a ≥ 4-fold increase in titer [1/dil] at D29)
NAI Ab titer ≥ 40 (1/dil)
Time frame: At Day 29
NAI Ab titer ≥ 40 (1/dil) at D29
2-fold and 4-fold rise in NAI titers
Time frame: Day 1 to Day 29
2-fold and 4-fold rise in NAI titers from D01 to D29
3 secondary outcomes
Neutralizing antibodies titers
Time frame: At Day 1 and Day 29
Individual neutralizing antibodies titer ratio
Time frame: At Day 1 and Day 29
2-fold and 4-fold increase in neutralizing titers
Time frame: Day 1 to Day 29
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 9 Jun 2026.
- FBP00021 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
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1, TIV mRNA-neuraminidase (NA) and TIV mRNA-HA Vaccine 2 in people with Influenza and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 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 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Australia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 unsolicited systemic adverse events (AEs) (time frame: Within 30 minutes after injection). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.