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

NCT06118151

CompletedPhase 1

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Influenza, Influenza Immunization

Interventions: Influenza Hemagglutinin mRNA vaccine, Quadrivalent Recombinant Influenza Vaccine

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Locations (20)

Rolling Hills Estates, California, United States
San Diego, California, United States
Coral Gables, Florida, United States
Hollywood, Florida, United States
Savannah, Georgia, United States
Peoria, Illinois, United States
El Dorado, Kansas, United States
Newton, Kansas, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Metairie, Louisiana, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Vestal, New York, United States
North Charleston, South Carolina, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
San Antonio, Texas, United States