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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Influenza Immunization
• Intervention / Treatment: Biological: mRNA NA vaccine; Biological: High Dose Quadrivalent Influenza Vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35802
      • AES - DRS - Optimal Research_Site 8400007
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Central Phoenix Medical Clinic, LLC_Site: 8400010
  • California
    • San Diego, California, United States, 92108
      • Optimal Research San Diego, LLC_Site: 8400009
  • Florida
    • Melbourne, Florida, United States, 32934-8172
      • AES - DRS - Optimal Research_Site 8400002
  • Illinois
    • Peoria, Illinois, United States, 61614-4885
      • AES - DRS - Optimal Research_Site 8400001
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Synexus Clinical Research_Site 8400003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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:

  1. 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
  2. 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 mRNA NA: Low dose Level; Participants will receive a low dose of mRNA vaccine	Biological: mRNA NA vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Experimental: Group 2 mRNA NA: Medium dose level; Participants will receive a medium dose of mRNA vaccine	Biological: mRNA NA vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Experimental: Group 3 mRNA NA: High dose level; Participants will receive a high dose of mRNA vaccine	Biological: mRNA NA vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Active Comparator: Group 4: QIV-HD; Participants will receive QIV-HD (high dose quadrivalent influenza) vaccine	Biological: High Dose Quadrivalent Influenza Vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; Other Names: Fluzone HD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with immediate adverse events	Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination	Within 30 minutes after vaccination
Number of participants with solicited injection site or systemic reaction		From Day 1 to Day 8
Number of participants with unsolicited adverse events	Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited reactions	From Day 1 to Day 29
Number of participants with serious adverse events	Serious adverse events are collected throughout the study	From Day 1 to Day 366
Number of participants with adverse events of special interest	Adverse events of special interest are collected throughout the study	From Day 1 to Day 366
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	From Day 1 to Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuraminidase inhibition (NAI) Antibodies at Day 1 and 29	Antibody are expressed as GMTs at baseline and post-baseline	Day 1 and 29
Individual Neuraminidase inhibition (NAI) titer	Antibody titers are expressed as GMTs at baseline and post-baseline	Day 1 and Day 29
2-fold and 4-fold rise in NAI antibody titers	Expressed as percentage post-baseline	From Day 1 to Day 29
Percentage of participants with detectable antibody titers greater than or equal to (≥) 10 [1/dil]	Expressed as percentage at baseline and post-baseline	Day 1 and Day 29

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

Helpful Links

• FBP00012 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Actual): January 3, 2024
• Study Completion (Actual): January 3, 2024

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; Influenza Vaccines
• Other Study ID Numbers: FBP00012; U1111-1266-5326 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No