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

Phase 1

Completed

• Conditions: Influenza; Influenza Immunization

• 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

Study Timeline

• Study Start: 2022-04-11
• Primary Completion: 2023-02-17
• Study Completion: 2023-02-17
• Status Verified: 2023-10
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 388

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

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

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