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NCT06118151 Clinical Trial

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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06118151
Other study ID # VAV00018
Secondary ID U1111-1271-2001
Status Completed
Phase Phase 1
First received
Last updated
Start date April 11, 2022
Est. completion date February 17, 2023

Study information
Verified date October 2023
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Description:

Approximately 6 months

Recruitment information / eligibility
Status Completed
Enrollment 388
Est. completion date February 17, 2023
Est. primary completion date February 17, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Influenza Hemagglutinin mRNA vaccine
Pharmaceutical form:Solution for injection-Route of administration:IM injection
• Quadrivalent Recombinant Influenza Vaccine
Pharmaceutical form:Solution for injection-Route of administration:IM injection

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

Sponsors (1)
Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after injection Number of participants with unsolicited systemic immediate adverse events (AEs) Within 30 minutes after injection
Primary 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 Number of participants with solicited injection site reactions Up to 7 days after injection
Primary Presence of solicited systemic reactions (ie, pre-listed in the participant's DC and in the eCRF) occurring up to 7 days after injection Number of participants with solicited systemic reactions Up to 7 days after injection
Primary Presence of unsolicited AEs reported up to 28 days after injection Number of participants with unsolicited AEs Up to 28 days after injection
Primary Presence of medically attended AEs (MAAEs) reported up to 28 days after injection Number of participants with medically attended adverse events (MAAE)s Up to 28 days after injection
Primary Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study Number of participants with serious adverse events (SAEs) From baseline up to 6 months
Primary Presence of out-of-range biological test results (including shift from baseline values) up to 28 days after injection Number of participants with out-of-range biological test results Up to 28 days after injection
Secondary Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181 Antibody titers are expressed as Geometric Mean Titers (GMTs) At Day 29, Day 91, and Day 181
Secondary Individual HAI Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29 Ratios of antibody titers measured by HAI in each group before and after vaccination From baseline up to 6 months
Secondary HAI Ab titer = 40 [1/dil] at D29, D91, and D181 At Day 29, Day 91 and Day 181
Secondary 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
Secondary Neutralizing Ab titers to homologous H3 strain at D29, D91, and D181 At Day 29, Day 91, and Day 181
Secondary Individual neutralizing Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29 From baseline up to 6 months
Secondary 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
Secondary HAI Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181 At Day 01, Day 29, D91 and D181
Secondary Neutralizing Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181 At Day 01, Day 29, Day 91, and Day 181
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