NCT06118151

Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older

A Phase I, Parallel, Randomized, Active-controlled, Multi-center, Dose-escalation Study With Early Safety Data Reviews to Assess Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adults 18 Years of Age and Older

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 388 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different dose levels of messenger ribonucleic acid (mRNA) vaccine encoding influenza hemagglutinin compared to an active control quadrivalent recombinant influenza vaccine (RIV4) in adults 18 years of age and older. Study details include: Study Duration: approximately 6 months Treatment Duration: 1 injection of mRNA vaccine encoding influenza hemagglutinin encoding influenza hemagglutinin or control. Visit Frequency: Screening visit, Day 01, Day 02, Day 03, Day 09, Day 29, Day 91, Day 181

Detailed description

Approximately 6 months

Conditions

• Influenza
• Influenza Immunization

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Hemagglutinin mRNA vaccine	Pharmaceutical form:Solution for injection-Route of administration:IM injection
BIOLOGICAL	Quadrivalent Recombinant Influenza Vaccine	Pharmaceutical form:Solution for injection-Route of administration:IM injection

Timeline

• Start date: 2022-04-11
• Primary completion: 2023-02-17
• Completion: 2023-02-17
• First posted: 2023-11-07
• Last updated: 2023-11-07

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study