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Influenza ImmunizationPhase 1NCT05426174

Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older

A Phase 1 study testing mRNA NA vaccine and High Dose Quadrivalent Influenza Vaccine in people with Influenza Immunization and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 6 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

This is a Phase I, first-in-human, randomized, modified double-blind, active-controlled, dose-escalation study to assess the safety and immunogenicity of up to 3 dose levels of mRNA NA vaccines, administered as a single IM injection in healthy adults aged 18 years and older. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza Immunization, Healthy Volunteers
What is being tested?
mRNA NA vaccine and High Dose Quadrivalent Influenza Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
233 participants
Where
6 sitesUnited States
Study dates
9 Jun 2022to 3 Jan 2024
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

  • Aged 18 years or older 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 before administration of study intervention.
  • Informed consent form has been signed and dated.

Who cannot join

  • 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; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
  • Moderate or severe acute illness/infection (according to investigator judgement) or febrile illness (temperature ≥100.4°F) on the day of study intervention administration.
  • Have known or recently active (12 months) neoplastic disease or a history of any hematologic malignancy.
  • Have any diagnosis, current or past, of autoimmune disease.
  • Body mass index of 40 kg/m2 or higher.
Show all 9Show fewer
  • Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
  • Have taken high-dose inhaled corticosteroid (≥500 μg of fluticasone) within 6 months prior to study vaccination.
  • Self-reported or documented seropositivity for HIV, hepatitis B virus, or hepatitis C virus.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Synexus Clinical Research_Site 8400003

    Cincinnati, Ohio, 45236

  • AES - DRS - Optimal Research_Site 8400007

    Huntsville, Alabama, 35802

  • AES - DRS - Optimal Research_Site 8400002

    Melbourne, Florida, 32934-8172

  • AES - DRS - Optimal Research_Site 8400001

    Peoria, Illinois, 61614-4885

  • Central Phoenix Medical Clinic, LLC_Site: 8400010

    Phoenix, Arizona, 85020

  • Optimal Research San Diego, LLC_Site: 8400009

    San Diego, California, 92108

Other trials in United States

About this study

Official title: Phase I, Randomized, Modified Double-blind, Parallel-group, Active-controlled, Multi-arm, Dose-escalation Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older

This is a Phase I, first-in-human, randomized, modified double-blind, active-controlled, dose-escalation study to assess the safety and immunogenicity of up to 3 dose levels of mRNA NA vaccines, administered as a single IM injection in healthy adults aged 18 years and older. Two age groups, 18 to 64 years and ≥65 years, will be included in this study.

Read the detailed description

This study will include a screening visit, 6 study visits occurring on Days 1, 3, 9, 29, 91, and 181, and a safety follow-up telephone call on Day 366.

Being tested
mRNA NA vaccine, High Dose Quadrivalent Influenza Vaccine
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA NA vaccineBiological

    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

  • High Dose Quadrivalent Influenza VaccineBiological

    Also called Fluzone HD

    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Study groups in NCT05426174
Study groupRoleWhat they receive
Group 1 mRNA NA: Low dose LevelExperimentalParticipants will receive a low dose of mRNA vaccine
Receives: Biological: mRNA NA vaccine
Group 2 mRNA NA: Medium dose levelExperimentalParticipants will receive a medium dose of mRNA vaccine
Receives: Biological: mRNA NA vaccine
Group 3 mRNA NA: High dose levelExperimentalParticipants will receive a high dose of mRNA vaccine
Receives: Biological: mRNA NA vaccine
Group 4: QIV-HDActive comparatorParticipants will receive QIV-HD (high dose quadrivalent influenza) vaccine
Receives: Biological: High Dose Quadrivalent Influenza Vaccine

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 reaction

    Measured: From Day 1 to Day 8

  3. Number of participants with unsolicited adverse events

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

    Measured: From Day 1 to Day 29

  4. Number of participants with serious adverse events

    Serious adverse events are collected throughout the study

    Measured: From Day 1 to Day 366

  5. Number of participants with adverse events of special interest

    Adverse events of special interest are collected throughout the study

    Measured: From Day 1 to Day 366

  6. Number of patients with clinically significant changes in clinical laboratory tests

    Laboratory tests include hematology: complete blood count (CBC) with differential, platelet count, coagulation panel (prothrombin time and PTT) and serum chemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total and fractionated bilirubin, C-reactive protein, serum creatinine, and blood urea nitrogen

    Measured: From Day 1 to Day 8

Secondary outcomes (4)

  1. Neuraminidase inhibition (NAI) Antibodies at Day 1 and 29

    Antibody are expressed as GMTs at baseline and post-baseline

    Measured: Day 1 and 29

  2. Individual Neuraminidase inhibition (NAI) titer

    Antibody titers are expressed as GMTs at baseline and post-baseline

    Measured: Day 1 and Day 29

  3. 2-fold and 4-fold rise in NAI antibody titers

    Expressed as percentage post-baseline

    Measured: From Day 1 to Day 29

  4. Percentage of participants with detectable antibody titers greater than or equal to (≥) 10 [1/dil]

    Expressed as percentage at baseline and post-baseline

    Measured: Day 1 and Day 29

Timeline

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

  1. First posted21 Jun 2022
  2. Study start9 Jun 2022
  3. Primary completion3 Jan 2024
  4. Study completion3 Jan 2024

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05426174
Sponsor's protocol ID
FBP00012
Other IDs
U1111-1266-5326
Status last verified
Sep 2025
First submitted
8 Jun 2022
Last updated
15 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mRNA NA vaccine and High Dose Quadrivalent Influenza Vaccine in people with Influenza Immunization and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 6 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 6 inclusion and 9 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 15 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 6 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 6 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 NCT05426174.

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 15 Sep 2025.

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