drugset / Trial / NCT06118151

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

NCT06118151

Phase 1 Completed 388 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupQuadruple-blindPrevention

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

Timeline

Start
2022-04-11
Primary completion
2023-02-17
Completion
2023-02-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Flublok Quadrivalent Vaccine Intramuscular
Subject Influenza Hemagglutinin mRNA vaccine Messenger RNA (mRNA) Intramuscular

Indications