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

Completed · Phase 1

Conditions studied: Influenza, Influenza Immunization

In brief

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

Key facts

Study ID

NCT06118151

Run by

Sanofi Pasteur, a Sanofi Company

People needed

388

Starts

2022-04-11

Expected to finish

2023-02-17

Last updated by the study team

2023-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Having given written informed consent prior to undertaking any study-related procedure. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
• Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Peninsula Research Associates Site Number : 8400013 — Rolling Hills Estates, California, United States
• Optimal Research Site Number : 8400026 — San Diego, California, United States
• AMR Coral Gables/Miami, Formerly Clinical Research of South Florida, an AMR company (Clinic) Site Number : 8400004 — Coral Gables, Florida, United States
• Research Centers of America Site Number : 8400003 — Hollywood, Florida, United States
• Meridian Clinical Research, LLC Site Number : 8400016 — Savannah, Georgia, United States
• AES Peoria Site Number : 8400017 — Peoria, Illinois, United States
• AMR El Dorado Site Number : 8400009 — El Dorado, Kansas, United States
• AMR - Newton Site Number : 8400005 — Newton, Kansas, United States
• AMR Wichita West Site Number : 8400030 — Wichita, Kansas, United States
• AMR Lexington Site Number : 8400014 — Lexington, Kentucky, United States
• Benchmark Research Site Number : 8400010 — Metairie, Louisiana, United States
• Quality Clinical Research Site Number : 8400018 — Omaha, Nebraska, United States
• Velocity Clinical Research, Omaha Site Number : 8400007 — Omaha, Nebraska, United States
• Velocity Clinical Research Vestal Site Number : 8400033 — Vestal, New York, United States
• Coastal Carolina Research Center - N Charleston Site Number : 8400008 — North Charleston, South Carolina, United States
• AMR Knoxville Site Number : 8400027 — Knoxville, Tennessee, United States
• Elligo Health Research, Inc. Site Number : 8400035 — Austin, Texas, United States
• Benchmark Research - Austin Site Number : 8400006 — Austin, Texas, United States
• AES Austin Site Number : 8400021 — Austin, Texas, United States
• Clinical Trials of Texas, Inc. Site Number : 8400012 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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