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

NCT05426174 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2025-09-15

No results posted yet for this study

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

Interventions

BIOLOGICAL

mRNA NA vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

High Dose Quadrivalent Influenza Vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-09
Primary Completion
2024-01-03
Completion
2024-01-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05426174 on ClinicalTrials.gov