NCT05426174

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Influenza Immunization
• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-09
• Primary completion: 2024-01-03
• Completion: 2024-01-03
• First posted: 2022-06-21
• Last updated: 2025-09-15

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study