> 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-to-an-mrna-based-8726ad11-2ee1-4444-859f-7b8b9d9f1b2a > Record changed: 2026-10-13 # A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 Years NCT06573281 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) Participants 213 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) Start date 2024-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) Number of sites 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) ## Title and summary **Summary** The purpose of this study is to assess the reactogenicity, safety and immune response of various formulations of the RSV mRNA investigational vaccine administered in healthy participants 18-45 years of age. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Short title** A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 Years Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Official title** A Phase 1, First-Time-in-Human (FTiH), Observer-blind, Randomized, Controlled Study to Evaluate the Safety, Reactogenicity and Immune Response of Various Doses of an mRNA-based Respiratory Syncytial Virus (RSV) Investigational Vaccine in Healthy Participants 18-45 Years of Age Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) ## Dates **Completion date** 2026-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **First posted** 2024-08-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Registry last updated** 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Primary completion date** 2026-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Start date** 2024-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) ## Size and sites **Actual participants** 213 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Participants** 213 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Number of sites** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) ## Identifiers **Registry ID** NCT06573281 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **ClinicalTrials.gov ID** NCT06573281 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Prevention **Masking** Quadruple masking **Masking description** Data will be collected in an observer-blind manner **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) ## Outcomes ### Primary outcomes 1. Number of participants reporting solicited administration site events within 7 days post-Dose 1 Timeframe: From Day 1 to Day 7 2. Number of participants reporting solicited administration site events within 7 days post-Dose 2 Timeframe: From Day 30 to Day 36 3. Number of participants reporting solicited systemic events within 7 days post-Dose 1 Timeframe: From Day 1 to Day 7 4. Number of participants reporting solicited systemic events within 7 days post-Dose 2 Timeframe: From Day 30 to Day 36 5. Number of participants reporting unsolicited adverse events (AEs) within 29 days post-Dose 1 Timeframe: From Day 1 to Day 29 6. Number of participants reporting unsolicited AEs within 29 days post-Dose 2 Timeframe: From Day 30 to Day 58 7. Number of participants reporting serious adverse events (SAEs) Timeframe: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2) 8. Number of participants reporting medically attended adverse events (MAAEs) Timeframe: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2) 9. Number of participants reporting adverse event of special interest (AESI) Timeframe: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2) 10. Number of participants reporting fatal SAEs Timeframe: From Day 1 (Dose 1) up to Month 13 (study end) 11. Number of participants reporting related SAEs Timeframe: From Day 1 (Dose 1) up to Month 13 (study end) 12. Number of participants reporting related AESIs Timeframe: From Day 1 (Dose 1) up to Month 13 (study end) 13. Number of participants with clinically significant hematological and biochemical abnormalities at pre-Dose 1 Timeframe: At Day 1 14. Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1 Timeframe: At Day 8 15. Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1 Timeframe: At Day 30 16. Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 2 Timeframe: At Day 37 ### Secondary outcomes 1. RSV- A neutralizing titers expressed as Geometric mean titers (GMTs) Timeframe: At Day 1 (pre-Dose 1), Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) 2. RSV- B neutralizing titers expressed as GMTs Timeframe: At Day 1 (pre-Dose 1), Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) 3. Geometric mean fold increase in serum neutralizing titers against RSV-A from baseline Timeframe: Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1) 4. Geometric mean fold increase in serum neutralizing titers against RSV-B from baseline Timeframe: Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1) 5. Number of participants with seroresponse in terms of neutralizing titer against RSV-A Timeframe: Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1) Seroresponse is defined as at least a 4-fold increase compared to pre-dosing titer. 6. Number of participants with seroresponse in terms of neutralizing titer against RSV-B Timeframe: Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1) Seroresponse is defined as at least a 4-fold increase compared to pre-dosing titer. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 45 Years **Healthy volunteers** Yes ### Inclusion criteria - Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits). - Written informed consent obtained from the participant prior to performance of any study-specific procedure. - Healthy participants as established by medical history, clinical examination and laboratory assessment at screening. - Male or female between and including 18 and 45 years of age at the time of enrollment into the study. - Body mass index more than or equal to (>=) 18 kg/m^2 and less than (<) 40 kg/m^2. - Female participants of non-childbearing potential may be enrolled in the study. - Female participants of childbearing potential may be enrolled in the study if the participant: - has practiced adequate contraception for 1 month prior to study intervention administration period, and - has a negative pregnancy test (on urine sample) on the day of study intervention administration, and - has agreed to continue adequate contraception during the entire treatment period and for at least 1 month after completion of the study intervention administration series. ### Exclusion criteria Medical conditions - History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions. - Hypersensitivity to latex. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). - Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality. - Recurrent history or uncontrolled neurological disorders or seizures. - Documented HIV, HBV, or HCV-positive participant. - Lymphoproliferative disorder or malignancy within 5 years before the first dose of study intervention administration. - History of or current suspicion of myocarditis or pericarditis. Prior/Concomitant therapy - Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) other than the study intervention during the period beginning 30 days before the first dose of study intervention administration (Day -29 to Day 1), or their planned use during the study period. - Has previously received an investigational or approved vaccine or antibody for prevention of RSV infection. - Planned administration/administration of a vaccine in the period starting 30 days before the first dose and ending 30 days after the last dose of study intervention administration, except for inactivated vaccines for influenza if they are received at least 14 days before the first dose or 14 days after the last study intervention administration. - Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. Prior/Concurrent clinical study experience • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device). Other exclusion criteria - Pregnant or lactating female participant. - Female participant planning to become pregnant or planning to discontinue contraceptive precautions within 1 month following the last study intervention administration. - Alcoholism or substance use disorder within the past 24 months. - Any study personnel or their immediate dependents, family, or household members. - Participants with extensive body markings or conditions in the deltoid region that may preclude accurate assessment of local reactogenicity. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) ## Sites - GSK Investigational SiteRolling Hills Estates, United States - GSK Investigational SiteAtlanta, United States - GSK Investigational SiteLenexa, United States - GSK Investigational SiteOmaha, United States - GSK Investigational SiteRochester, United States - GSK Investigational SiteCamberwell, Australia - GSK Investigational SiteMadrid, Spain - GSK Investigational SiteMadrid, Spain - GSK Investigational SiteMadrid, Spain Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) ## References ### Other registry identifiers - 2024-512846-41 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06573281) ## Related records ### Drugs (1) - [Canakinumab](https://trialight.com/data/asset/canakinumab-7cd74b21-082d-4a09-8847-aa6d401bc853.md) ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Conditions (1) - [Respiratory syncytial virus infectious disease](https://trialight.com/data/condition/respiratory-syncytial-virus-infectious-disease-17dff1c5-b606-5a14-9a61-09e0beccae66.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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