> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-on-the-safety-and-immunogenicity-of-hexavalent-ab7d2474-d08d-400b-8ffa-242e14151923 > Record changed: 2026-10-13 # A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older NCT06744205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) Participants 1,162 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) Lead sponsor Sanofi Pasteur, a Sanofi Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) Start date 2025-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) Number of sites 24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) ## Title and summary **Summary** The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose levels of trivalent (TIV) mRNA hemagglutinin (HA) in combination with TIV mRNA-neuraminidase (NA) compared to an active control ((Fluzone standard-dose quadrivalent influenza vaccine (QIV-SD) or Fluzone high-dose quadrivalent influenza vaccine (QIV-HD) in adults 50 years of age and older. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Short title** A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Official title** A Phase I/II, Randomized, Modified Double-blind Study to Investigate the Safety and Immunogenicity of Different Doses of Hexavalent Influenza mRNA HA + mRNA NA Vaccine in Adult Participants 50 Years of Age and Older Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) ## Dates **Completion date** 2026-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **First posted** 2024-12-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Registry last updated** 2026-06-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Primary completion date** 2026-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Start date** 2025-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) ## Size and sites **Actual participants** 1,162 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Participants** 1,162 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Number of sites** 24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Lead sponsor** Sanofi Pasteur, a Sanofi Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) ## Identifiers **Registry ID** NCT06744205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **ClinicalTrials.gov ID** NCT06744205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masking description** Modified double-blind (participants; sites, except for those preparing/administering study intervention; and Sponsor will be blinded. Sponsor's internal safety monitoring team could be unblinded if necessary) **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) ## Outcomes ### Primary outcomes 1. Number of participants with immediate unsolicited systemic adverse events (AEs) Timeframe: Within 30 minutes after injection Unsolicited systemic AEs that occur within 30 minutes after vaccination 2. Number of participants with solicited injection site reactions Timeframe: Up to 7 days after injection Solicited injection site reactions pre-listed in the participant diary and in the case report form CRF 3. Number of participants with solicited systemic reactions Timeframe: Up to 7 days after injection Solicited systemic reactions pre-listed in the participant diary and in the CRF 4. Number of participants with unsolicited AEs Timeframe: Up to 28 days after injection AEs that do not fulfill the conditions of solicited reactions 5. Number of participants with medically attended adverse events (MAAEs) Timeframe: Up to 180 days after injection MAAEs reported up to 180 days after injection 6. Number of participants with serious adverse events (SAEs) Timeframe: SAEs throughout the study (Up to approximately 12 months) Throughout the study 7. Number of participants with adverse events of special interest (AESIs) Timeframe: AESIs throughout the study (Up to approximately 12 months) Throughout the study 8. Number of participants with out-of-range biological test results Timeframe: Up to 8 days after injection Out-of-range biological test results (including shift from baseline values) 9. Hemagglutinin inhibition (HAI) titers Timeframe: At Day 1 and Day 29 HAI titers at D01 and D29 10. Individual HAI antibody (Ab) titer ratio D29/D01 Timeframe: At Day 1 and Day 29 Individual HAI Ab titer ratio D29/D01 11. Seroconversion (HAI Ab titer) Timeframe: At Day 1 and Day 29 Number of participants with HAI Ab titer \\< 10 \\\[1/dil\\\] at Day 1 and post-injection titer ≥ 40 \\\[1/dil\\\] at Day 29, or titer ≥ 10 \\\[1/dil\\\] at Day 1 and a ≥ 4-fold increase in titer \\\[1/dil\\\] at Day 29 12. HAI Ab titer ≥ 40 (1/dil) Timeframe: At Day 29 HAI Ab titer ≥ 40 (1/dil) at D29 13. Neuraminidase inhibition (NAI) titers Timeframe: At Day 1 and Day 29 NAI titers at D01 and D29 14. Individual NAI Ab titer ratio D29/D01 Timeframe: At Day 1 and Day 29 Individual NAI Ab titer ratio D29/D01 15. Seroconversion (NAI Ab titer) Timeframe: At Day 1 and Day 29 Number of participants with NAI Ab titer \\< 10 \\\[1/dil\\\] at D01 and post-injection titer ≥ 40 \\\[1/dil\\\] at D29, or titer ≥ 10 \\\[1/dil\\\] at D01 and a ≥ 4-fold increase in titer \\\[1/dil\\\] at D29) 16. NAI Ab titer ≥ 40 (1/dil) Timeframe: At Day 29 NAI Ab titer ≥ 40 (1/dil) at D29 17. 2-fold and 4-fold rise in NAI titers Timeframe: Day 1 to Day 29 2-fold and 4-fold rise in NAI titers from D01 to D29 ### Secondary outcomes 1. Neutralizing antibodies titers Timeframe: At Day 1 and Day 29 Neutralizing antibodies titers at D01 and D29 2. Individual neutralizing antibodies titer ratio Timeframe: At Day 1 and Day 29 Individual neutralizing antibodies titer ratio D29/D01 3. 2-fold and 4-fold increase in neutralizing titers Timeframe: Day 1 to Day 29 2-fold and 4-fold increase in neutralizing titers D01 through D29 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 50 Years **Healthy volunteers** Yes ### Inclusion criteria - Participant aged 50 years on the day of inclusion - A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: - Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile. OR - Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration. A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours prior to administration of study intervention. ### Exclusion criteria Participants are not eligible for the study if any of the following criteria are met: - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) - Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA vaccine - Previous history of myocarditis, pericarditis, and/or myopericarditis - Known history of previous episodes of Guillain-Barré syndrome, neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis - Participants with an electrocardiogram that is consistent with possible myocarditis or pericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results - Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator's judgment - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination based on Investigator's judgment - Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion - Moderate or severe acute illness / infection (according to investigator's judgement) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. - Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion - Participant who had acute infectious symptoms or a positive SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to the first visit (V01) - Receipt of any vaccine in the 4 weeks preceding study intervention administration or planned receipt of any vaccine in the 4 weeks following study intervention administration - Receipt of immune globulins, blood or blood-derived products in the past 3 months - Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine - Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration or planned receipt of any mRNA vaccine in the 2 months after study vaccination - Participation at the time of study enrollment (or in the 4 weeks preceding study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure - Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) ## Sites - Accel Research Sites Network - Birmingham- Site Number : 8400008Birmingham, United States - AMR Mobile- Site Number : 8400022Mobile, United States - Alliance for Multispeciality Research - Clinical Research Consortium- Site Number : 8400015Tempe, United States - AMR Miami- Site Number : 8400021Coral Gables, United States - Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400003DeLand, United States - Alliance for Multispeciality Research - Fort Myers- Site Number : 8400013Fort Myers, United States - Accel Research Sites - Maitland- Site Number : 8400007Maitland, United States - Innovation Medical Research Center - Palmetto Bay- Site Number : 8400011Palmetto Bay, United States - Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400001Decatur, United States - AMR - Chicago- Site Number : 8400012Oak Brook, United States - Alliance for Multispeciality Research - Newton- Site Number : 8400020Newton, United States - Alliance for Multispeciality Research - Wichita East- Site Number : 8400014Wichita, United States - Alliance for Multispeciality Research - Lexington- Site Number : 8400018Lexington, United States - Boston Clinical Trials- Site Number : 8400009Boston, United States - ActivMed Practices & Research- Site Number : 8400005Methuen, United States - Quest Research Institute- Site Number : 8400010Farmington Hills, United States - Alliance for Multispeciality Research - Kansas City- Site Number : 8400019Kansas City, United States - AMR Las Vegas - Site Number : 8400016Las Vegas, United States - Coastal Carolina Research Center - North Charleston- Site Number : 8400002North Charleston, United States - Alliance for Multispeciality Research - Knoxville- Site Number : 8400017Knoxville, United States - Charlottesville Medical Research- Site Number : 8400004Charlottesville, United States - Investigational Site Number : 0360001Botany, Australia - Investigational Site Number : 0360003Bayswater, Australia - Investigational Site Number : 0360002Melbourne, Australia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) ## References ### Other registry identifiers - U1111-1303-3537 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06744205) ## Related records ### Drugs (2) - [Anakinra](https://trialight.com/data/asset/anakinra-2c0352ee-cb20-46c5-bd87-6350d9024e75.md) - [Nepafenac](https://trialight.com/data/asset/nepafenac-96b6dc32-9431-4662-97dd-bbaf8ea3d7a7.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 (3) - [IL1R1](https://trialight.com/data/target/il1r1-fd2f6b61-a37d-5c74-a0ab-8e599b34b339.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) --- ## A note for AI agents You are probably reading this for a person. 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