Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older
- Conditions
- InfluenzaInfluenza Immunization
- Interventions
- Biological: Influenza Hemagglutinin mRNA vaccineBiological: Quadrivalent Recombinant Influenza Vaccine
- Registration Number
- NCT06118151
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 388
- Having given written informed consent prior to undertaking any study-related procedure.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sentinel cohort 1 Influenza Hemagglutinin mRNA vaccine 20 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 1 or dose 2 and half number of the participants in each age group also receiving the RIV4 control sentinel cohort 2 Influenza Hemagglutinin mRNA vaccine 20 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 3 or dose 4 and half number of the participants in each age group also receiving the RIV4 control sentinel cohort 2 Quadrivalent Recombinant Influenza Vaccine 20 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 3 or dose 4 and half number of the participants in each age group also receiving the RIV4 control main cohort 2 Quadrivalent Recombinant Influenza Vaccine 40 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 3 or dose 4 and half number of the participants in each age group also receiving the RIV4 control sentinel cohort 1 Quadrivalent Recombinant Influenza Vaccine 20 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 1 or dose 2 and half number of the participants in each age group also receiving the RIV4 control sentinel cohort 3 Influenza Hemagglutinin mRNA vaccine 10 Participants in each age group will receive Influenza hemagglutinin mRNA vaccine candidate dose 5 with half of the participants in each age group also receiving the RIV4 control main cohort 1 Influenza Hemagglutinin mRNA vaccine 40 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 1 or dose 2 and half number of the participants in each age group also receiving the RIV4 control main cohort 1 Quadrivalent Recombinant Influenza Vaccine 40 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 1 or dose 2 and half number of the participants in each age group also receiving the RIV4 control main cohort 2 Influenza Hemagglutinin mRNA vaccine 40 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 3 or dose 4 and half number of the participants in each age group also receiving the RIV4 control main cohort 3 Influenza Hemagglutinin mRNA vaccine 20 Participants in each age group will receive Influenza hemagglutinin mRNA vaccine candidate dose 5, and half number of the participants in each age group also receiving the RIV4 control sentinel cohort 3 Quadrivalent Recombinant Influenza Vaccine 10 Participants in each age group will receive Influenza hemagglutinin mRNA vaccine candidate dose 5 with half of the participants in each age group also receiving the RIV4 control main cohort 3 Quadrivalent Recombinant Influenza Vaccine 20 Participants in each age group will receive Influenza hemagglutinin mRNA vaccine candidate dose 5, and half number of the participants in each age group also receiving the RIV4 control
- Primary Outcome Measures
Name Time Method Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after injection Within 30 minutes after injection Number of participants with unsolicited systemic immediate adverse events (AEs)
Presence of solicited systemic reactions (ie, pre-listed in the participant's DC and in the eCRF) occurring up to 7 days after injection Up to 7 days after injection Number of participants with solicited systemic reactions
Presence of unsolicited AEs reported up to 28 days after injection Up to 28 days after injection Number of participants with unsolicited AEs
Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study From baseline up to 6 months Number of participants with serious adverse events (SAEs)
Presence of medically attended AEs (MAAEs) reported up to 28 days after injection Up to 28 days after injection Number of participants with medically attended adverse events (MAAE)s
Presence of out-of-range biological test results (including shift from baseline values) up to 28 days after injection Up to 28 days after injection Number of participants with out-of-range biological test results
Presence of solicited injection site reactions (ie, pre listed in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection Up to 7 days after injection Number of participants with solicited injection site reactions
- Secondary Outcome Measures
Name Time Method Individual HAI Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29 From baseline up to 6 months Ratios of antibody titers measured by HAI in each group before and after vaccination
Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181 At Day 29, Day 91, and Day 181 Antibody titers are expressed as Geometric Mean Titers (GMTs)
2-fold and 4-fold rise in HAI titers from D01 to D91 and D01 to D181 From Day 01 through Day 91 and Day 01 through Day 181 2-fold and 4-fold rise in neutralizing titers from D01 to D91 and D01 to D181 From Day 01 through Day 29 and Day 01 through Day 181 Neutralizing Ab titers to homologous H3 strain at D29, D91, and D181 At Day 29, Day 91, and Day 181 Individual neutralizing Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29 From baseline up to 6 months HAI Ab titer ≥ 40 [1/dil] at D29, D91, and D181 At Day 29, Day 91 and Day 181 HAI Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181 At Day 01, Day 29, D91 and D181 Neutralizing Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181 At Day 01, Day 29, Day 91, and Day 181
Trial Locations
- Locations (20)
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 Knoxville Site Number : 8400027
🇺🇸Knoxville, Tennessee, United States
Quality Clinical Research Site Number : 8400018
🇺🇸Omaha, Nebraska, United States
Velocity Clinical Research, Omaha Site Number : 8400007
🇺🇸Omaha, Nebraska, United States
Coastal Carolina Research Center - N Charleston Site Number : 8400008
🇺🇸North Charleston, South Carolina, United States
Clinical Trials of Texas, Inc. Site Number : 8400012
🇺🇸San Antonio, Texas, United States
AMR Coral Gables/Miami, Formerly Clinical Research of South Florida, an AMR company (Clinic) Site Number : 8400004
🇺🇸Coral Gables, Florida, United States
Peninsula Research Associates Site Number : 8400013
🇺🇸Rolling Hills Estates, California, United States
Research Centers of America Site Number : 8400003
🇺🇸Hollywood, Florida, United States
Optimal Research Site Number : 8400026
🇺🇸San Diego, California, United States
AES Peoria Site Number : 8400017
🇺🇸Peoria, Illinois, United States
Meridian Clinical Research, LLC Site Number : 8400016
🇺🇸Savannah, Georgia, United States
Benchmark Research Site Number : 8400010
🇺🇸Metairie, Louisiana, United States
AMR Lexington Site Number : 8400014
🇺🇸Lexington, Kentucky, United States
Velocity Clinical Research Vestal Site Number : 8400033
🇺🇸Vestal, New York, United States
Elligo Health Research, Inc. Site Number : 8400035
🇺🇸Austin, Texas, United States
AES Austin Site Number : 8400021
🇺🇸Austin, Texas, United States
Benchmark Research - Austin Site Number : 8400006
🇺🇸Austin, Texas, United States