> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-immunogenicity-of-a-monovalent-mrna-vaccine-d0d2187e-dc39-415e-b135-4adafc157dbd > Record changed: 2026-10-13 # Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older NCT06118151 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) Participants 388 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) Lead sponsor Sanofi Pasteur, a Sanofi Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) Start date 2022-04-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) Number of sites 20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Short title** Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) ## Dates **Completion date** 2023-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **First posted** 2023-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Registry last updated** 2023-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Primary completion date** 2023-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Start date** 2022-04-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) ## Size and sites **Actual participants** 388 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Participants** 388 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Number of sites** 20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Lead sponsor** Sanofi Pasteur, a Sanofi Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) ## Identifiers **Registry ID** NCT06118151 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **ClinicalTrials.gov ID** NCT06118151 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masking description** Open label (Sponsor) Blinded (Sites, except for those preparing/administering study intervention) **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) ## Outcomes ### Primary outcomes 1. Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after injection Timeframe: Within 30 minutes after injection Number of participants with unsolicited systemic immediate adverse events (AEs) 2. 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 Number of participants with solicited injection site reactions 3. 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 Number of participants with solicited systemic reactions 4. Presence of unsolicited AEs reported up to 28 days after injection Timeframe: Up to 28 days after injection Number of participants with unsolicited AEs 5. Presence of medically attended AEs (MAAEs) reported up to 28 days after injection Timeframe: Up to 28 days after injection Number of participants with medically attended adverse events (MAAE)s 6. Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study Timeframe: From baseline up to 6 months Number of participants with serious adverse events (SAEs) 7. 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 Number of participants with out-of-range biological test results ### Secondary outcomes 1. Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181 Timeframe: At Day 29, Day 91, and Day 181 Antibody titers are expressed as Geometric Mean Titers (GMTs) 2. Individual HAI Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29 Timeframe: From baseline up to 6 months Ratios of antibody titers measured by HAI in each group before and after vaccination 3. HAI Ab titer ≥ 40 \[1/dil\] at D29, D91, and D181 Timeframe: At Day 29, Day 91 and Day 181 4. 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 5. Neutralizing Ab titers to homologous H3 strain at D29, D91, and D181 Timeframe: At Day 29, Day 91, and Day 181 6. Individual neutralizing Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29 Timeframe: From baseline up to 6 months 7. 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 8. HAI Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181 Timeframe: At Day 01, Day 29, D91 and D181 9. 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) ## Sites - Peninsula Research Associates Site Number : 8400013Rolling Hills Estates, United States - Optimal Research Site Number : 8400026San Diego, United States - AMR Coral Gables/Miami, Formerly Clinical Research of South Florida, an AMR company (Clinic) Site Number : 8400004Coral Gables, United States - Research Centers of America Site Number : 8400003Hollywood, United States - Meridian Clinical Research, LLC Site Number : 8400016Savannah, United States - AES Peoria Site Number : 8400017Peoria, United States - AMR El Dorado Site Number : 8400009El Dorado, United States - AMR - Newton Site Number : 8400005Newton, United States - AMR Wichita West Site Number : 8400030Wichita, United States - AMR Lexington Site Number : 8400014Lexington, United States - Benchmark Research Site Number : 8400010Metairie, United States - Quality Clinical Research Site Number : 8400018Omaha, United States - Velocity Clinical Research, Omaha Site Number : 8400007Omaha, United States - Velocity Clinical Research Vestal Site Number : 8400033Vestal, United States - Coastal Carolina Research Center - N Charleston Site Number : 8400008North Charleston, United States - AMR Knoxville Site Number : 8400027Knoxville, United States - Elligo Health Research, Inc. Site Number : 8400035Austin, United States - Benchmark Research - Austin Site Number : 8400006Austin, United States - AES Austin Site Number : 8400021Austin, United States - Clinical Trials of Texas, Inc. Site Number : 8400012San Antonio, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) ## References ### Other registry identifiers - U1111-1271-2001 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06118151) ## Related records ### Drugs (2) - [Interferon alfa-2A](https://trialight.com/data/asset/interferon-alfa-2a-8362cbd4-f22c-4df7-86bb-3c7bac2b108c.md) - [VIS-410](https://trialight.com/data/asset/vis-410-5c3293df-9e06-4818-874d-01fe0c148e8f.md) ### Lead sponsors (1) - [Sanofi Pasteur, a Sanofi Company](https://trialight.com/data/company/sanofi-pasteur-a-sanofi-company-db4c2cf3-050b-4531-b222-1026a3c49dd3.md) ### Conditions (1) - [Influenza](https://trialight.com/data/condition/influenza-ea12369b-7ed6-5f6b-94fe-eb0e56c24def.md) Primary condition ### Targets (2) - [IFNAR1](https://trialight.com/data/target/ifnar1-b87a0a08-6346-52f4-927e-c5d552c5babd.md) - [IFNAR2](https://trialight.com/data/target/ifnar2-810ce9c4-ab9c-5d25-aff1-f53086c07427.md) --- ## A note for AI agents You are probably reading this for a person. 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