> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-on-the-safety-and-immune-response-of-investigational-aaa5714c-815b-4ae7-8b7a-1e3c33b1400d > Record changed: 2026-10-13 # A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults NCT07464314 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) Participants 225 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) Start date 2026-03-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) Number of sites 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) ## Title and summary **Summary** This early-stage study will look at a new mRNA vaccine that combines defenses against both seasonal flu and COVID-19 in terms of its safety and how it builds protection. Healthy adults aged 65 to 85 will receive different doses of this new vaccine, a standard flu vaccine, or COVID-19 vaccine. The study will assess any side effects or health issues, and additional blood samples will be collected at specific times to evaluate how well participants bodies build protection against the flu and COVID-19. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Short title** A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Official title** A Phase 1, Observer-Blind, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of an Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) ## Dates **Completion date** 2027-06-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **First posted** 2026-03-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Registry last updated** 2026-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Primary completion date** 2026-12-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Start date** 2026-03-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) ## Size and sites **Participants** 225 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Planned participants** 225 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Number of sites** 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) ## Identifiers **Registry ID** NCT07464314 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **ClinicalTrials.gov ID** NCT07464314 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Prevention **Masking** Triple masking **Masking description** This is an observer-blind study. **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) ## Outcomes ### Primary outcomes 1. Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities Following Administration of the Study Intervention Timeframe: Day 1 to Day 3 The assessed toxicity grades for laboratory value abnormalities will be defined as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Potentially life-threatening. 2. Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention Timeframe: Day 1 to Day 8 3. Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention Timeframe: Day 1 to Day 29 4. Number of Participants with Solicited Administration Site Adverse Events (AEs) Timeframe: Day 1 to Day 7 The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy. 5. Number of Participants with Solicited Systemic AEs Timeframe: Day 1 to Day 7 The solicited systemic AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills. 6. Number of Participants with Unsolicited AEs Timeframe: Day 1 to Day 28 An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. 7. Number of Participants with Serious Adverse Events (SAEs) Timeframe: Day 1 to Day 181 A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment. 8. Number of Participants with Adverse Events of Special Interest (AESIs) Timeframe: Day 1 to Day 181 The following events are considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, Aminotransferase elevation; myocarditis/pericarditis within 6 weeks after study intervention administration and potential immune-mediated diseases (pIMDs). 9. Number of Participants with Medically Attended Adverse Events (MAAEs) Timeframe: Day 1 to Day 181 A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional. ### Secondary outcomes 1. Geometric Mean Titer (GMT) Of Antigen 1 Titer Timeframe: At Day 29 2. Percentage of Participants with Antigen 1 Seroconversion Rate (SCR) Timeframe: Day 1 to Day 29 3. Percentage of Participants with Antigen 1 Seroprotection Rate (SPR) Timeframe: At Day 1 and Day 29 4. Geometric Mean Increase (GMI) of Antigen 1 Titer Timeframe: Day 1 to Day 29 5. GMT Of Antigen 2 Titer Timeframe: At Day 29 6. Percentage of Participants with Antigen 2 SCR Timeframe: Day 1 to Day 29 7. GMI of Antigen 2 Titer Timeframe: Day 1 to Day 29 8. GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) Timeframe: At Day 29 9. Percentage of participants with seroresponse of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) Timeframe: Day 1 to Day 29 10. GMI of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) Timeframe: Day 1 to Day 29 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) ## Eligibility **Sex** All **Age groups** Older adults **Minimum age** 65 Years **Maximum age** 85 Years **Healthy volunteers** No ### Inclusion criteria 1. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance of the caregiver. 2. Informed consent obtained from the participant prior to performance of any study-specific procedure. 3. A male or female 65 to 85 years of age (YoA) (inclusive) at the time of screening. 4. Healthy participants or medically stable patients as established by medical history and clinical examination. 5. Other protocol-defined inclusion criteria may apply. ### Exclusion criteria 1. Any clinically significant laboratory abnormality. 2. History of symptomatic influenza/ SARS-CoV-2 infection confirmed by local health authority-approved testing methods within 180 days (for influenza) or 90 days (SARS-CoV-2 infection) prior to study intervention administration. 3. History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine. 4. Current or past malignancy, unless completely resolved without clinically significant sequelae (e.g., no evidence of disease following successful treatment of basal cell carcinoma cases are allowed) for >5 years. 5. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 6. History of or current suspicion of myocarditis or pericarditis (including following administration of an mRNA vaccine); or idiopathic cardiomyopathy, or presence of any medical condition that increases the risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection. 7. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). 8. Acute or unstable chronic conditions, clinically significant pulmonary, cardiovascular, or renal functional abnormality, as determined by physical examination and/or laboratory screening tests. 9. History of hypersensitivity or allergic reaction to any previous influenza or COVID-19 vaccine. 10. History of hypersensitivity or allergic reaction to any previous mRNA vaccine. 11. Administration of any influenza vaccine within 181 days before the study intervention administration (Day -180 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration. 12. Administration of a SARS-CoV-2 antigen-containing vaccine in the period starting 91 days before the study intervention administration (Day -90 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration. 13. Administration of any mRNA-based vaccine in the period starting 29 days before the study intervention administration (Day -28 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration. 14. Administration of any other vaccine not foreseen by the study protocol in the period starting 29 days (Day -28 to Day 1) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration. 15. Other protocol-defined exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) ## Sites - GSK Investigational SiteAnniston, United StatesRecruiting - GSK Investigational SiteLittle Rock, United StatesRecruiting - GSK Investigational SiteFair Oaks, United StatesRecruiting - GSK Investigational SiteSan Diego, United StatesRecruiting - GSK Investigational SiteMiami, United StatesRecruiting - GSK Investigational SiteMiami Lakes, United StatesRecruiting - GSK Investigational SiteWest Palm Beach, United StatesRecruiting - GSK Investigational SiteStockbridge, United StatesRecruiting - GSK Investigational SiteAustin, United StatesRecruiting - GSK Investigational SiteCharlottesville, United StatesRecruiting - GSK Investigational SiteNewport News, United StatesRecruiting - GSK Investigational SiteSeattle, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07464314) ## Related records ### Drugs (2) - [Canakinumab](https://trialight.com/data/asset/canakinumab-7cd74b21-082d-4a09-8847-aa6d401bc853.md) - [Fluticasone](https://trialight.com/data/asset/fluticasone-07b854dc-6b49-4d3b-8c5a-54e2b7a89943.md) ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Conditions (2) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) - [Influenza](https://trialight.com/data/condition/influenza-ea12369b-7ed6-5f6b-94fe-eb0e56c24def.md) Primary condition ### Targets (1) - [IL1B](https://trialight.com/data/target/il1b-a893351e-84c8-5959-8b42-db764a8a634f.md) --- ## A note for AI agents You are probably reading this for a person. 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