Clinical trial NCT06118151: Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Influenza Immunization
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after injection
timeFrame: Within 30 minutes after injection
measure: 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
timeFrame: Up to 7 days after injection
measure: Presence of solicited systemic reactions (ie, pre-listed in the participant's DC and in the eCRF) occurring up to 7 days after injection
timeFrame: Up to 7 days after injection
measure: Presence of unsolicited AEs reported up to 28 days after injection
timeFrame: Up to 28 days after injection
measure: Presence of medically attended AEs (MAAEs) reported up to 28 days after injection
timeFrame: Up to 28 days after injection
measure: Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study
timeFrame: From baseline up to 6 months
measure: Presence of out-of-range biological test results (including shift from baseline values) up to 28 days after injection
timeFrame: Up to 28 days after injection
Secondary outcomes:
measure: Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181
timeFrame: At Day 29, Day 91, and Day 181
measure: Individual HAI Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29
timeFrame: From baseline up to 6 months
measure: HAI Ab titer ≥ 40 [1/dil] at D29, D91, and D181
timeFrame: At Day 29, Day 91 and Day 181
measure: 2-fold and 4-fold rise in HAI titers from D01 to D91 and D01 to D181
timeFrame: From Day 01 through Day 91 and Day 01 through Day 181
measure: Neutralizing Ab titers to homologous H3 strain at D29, D91, and D181
timeFrame: At Day 29, Day 91, and Day 181
measure: Individual neutralizing Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29
timeFrame: From baseline up to 6 months
measure: 2-fold and 4-fold rise in neutralizing titers from D01 to D91 and D01 to D181
timeFrame: From Day 01 through Day 29 and Day 01 through Day 181
measure: HAI Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181
timeFrame: At Day 01, Day 29, D91 and D181
measure: Neutralizing Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181
timeFrame: At Day 01, Day 29, Day 91, and Day 181
Other outcomes:
Locations:
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates Site Number : 8400013
state: California
city: San Diego
country: United States
facility: Optimal Research Site Number : 8400026
state: California
city: Coral Gables
country: United States
facility: AMR Coral Gables/Miami, Formerly Clinical Research of South Florida, an AMR company (Clinic) Site Number : 8400004
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America Site Number : 8400003
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC Site Number : 8400016
state: Georgia
city: Peoria
country: United States
facility: AES Peoria Site Number : 8400017
state: Illinois
city: El Dorado
country: United States
facility: AMR El Dorado Site Number : 8400009
state: Kansas
city: Newton
country: United States
facility: AMR - Newton Site Number : 8400005
state: Kansas
city: Wichita
country: United States
facility: AMR Wichita West Site Number : 8400030
state: Kansas
city: Lexington
country: United States
facility: AMR Lexington Site Number : 8400014
state: Kentucky
city: Metairie
country: United States
facility: Benchmark Research Site Number : 8400010
state: Louisiana
city: Omaha
country: United States
facility: Quality Clinical Research Site Number : 8400018
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha Site Number : 8400007
state: Nebraska
city: Vestal
country: United States
facility: Velocity Clinical Research Vestal Site Number : 8400033
state: New York
city: North Charleston
country: United States
facility: Coastal Carolina Research Center - N Charleston Site Number : 8400008
state: South Carolina
city: Knoxville
country: United States
facility: AMR Knoxville Site Number : 8400027
state: Tennessee
city: Austin
country: United States
facility: Elligo Health Research, Inc. Site Number : 8400035
state: Texas
city: Austin
country: United States
facility: Benchmark Research - Austin Site Number : 8400006
state: Texas
city: Austin
country: United States
facility: AES Austin Site Number : 8400021
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc. Site Number : 8400012
state: Texas
Study officials:
References: