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

NCT05426174 | Completed Phase 1 FDA Drug

• 2 other identifiers: FBP00012U1111-1266-5326
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 6

Brief 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. Two age groups, 18 to 64 years and ≥65 years, will be included in this study.

Conditions

Influenza Immunization; Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

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

  Day 1 and 29

• Individual Neuraminidase inhibition (NAI) titer

  Day 1 and Day 29

• 2-fold and 4-fold rise in NAI antibody titers

  From Day 1 to Day 29

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

  Day 1 and Day 29

Study Arms (4)

Group 1 mRNA NA: Low dose Level

EXPERIMENTAL

Participants will receive a low dose of mRNA vaccine

Biological: mRNA NA vaccine

Group 2 mRNA NA: Medium dose level

EXPERIMENTAL

Participants will receive a medium dose of mRNA vaccine

Biological: mRNA NA vaccine

Group 3 mRNA NA: High dose level

EXPERIMENTAL

Participants will receive a high dose of mRNA vaccine

Biological: mRNA NA vaccine

Group 4: QIV-HD

ACTIVE COMPARATOR

Participants will receive QIV-HD (high dose quadrivalent influenza) vaccine

Biological: High Dose Quadrivalent Influenza Vaccine

Interventions

mRNA NA vaccine BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Group 1 mRNA NA: Low dose Level; Group 2 mRNA NA: Medium dose level; Group 3 mRNA NA: High dose level

High Dose Quadrivalent Influenza Vaccine BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Also known as: Fluzone HD

Group 4: QIV-HD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (6)

AES - DRS - Optimal Research_Site 8400007

Huntsville, Alabama, 35802, United States

Location

Central Phoenix Medical Clinic, LLC_Site: 8400010

Phoenix, Arizona, 85020, United States

Location

Optimal Research San Diego, LLC_Site: 8400009

San Diego, California, 92108, United States

Location

AES - DRS - Optimal Research_Site 8400002

Melbourne, Florida, 32934-8172, United States

Location

AES - DRS - Optimal Research_Site 8400001

Peoria, Illinois, 61614-4885, United States

Location

Synexus Clinical Research_Site 8400003

Cincinnati, Ohio, 45236, United States

Location

Related Links

• FBP00012 Plain Language Results Summary

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will be blinded to participants, investigators/sub-investigators, outcomes assessors, laboratory personnel, and the sponsor study staff (with the exception noted for study staff involved in the ESDRs). Study staff involved in the ESDRs will be unblinded to group assignment of participants in the sentinel safety cohorts. After the ESDRs are performed for the sentinel safety cohorts, the SMT will continue monitoring the safety aspects of the study as part of blinded periodic safety reviews. Those preparing/administering the study interventions will be unblinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 21, 2022
• Study Start: June 9, 2022
• Primary Completion: January 3, 2024
• Study Completion: January 3, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (6)