> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-on-the-immune-response-and-safety-elicited-by-a-355dd8d4-bf2e-4cf6-8dff-94e7629cd5e7 > Record changed: 2026-10-13 # A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above NCT05559476 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) Participants 1,029 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) Start date 2022-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) Number of sites 46 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) ## Title and summary **Summary** The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Short title** A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Official title** A Phase 3, Open-label, Randomized, Controlled, Multicountry Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU HD Vaccine in Adults Aged 65 Years and Above Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) ## Dates **Completion date** 2023-08-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **First posted** 2022-09-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Registry last updated** 2024-09-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Primary completion date** 2023-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Start date** 2022-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) ## Size and sites **Actual participants** 1,029 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Participants** 1,029 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Number of sites** 46 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) ## Identifiers **Registry ID** NCT05559476 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **ClinicalTrials.gov ID** NCT05559476 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) ## Outcomes ### Primary outcomes 1. RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs) Timeframe: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) RSV-A neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60). 2. Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs Timeframe: At 1 month after the FLU vaccine dose (Day 31 for both groups) HI titers were assessed against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata strains. 3. RSV-B Neutralizing Titers Expressed as Group GMTs Timeframe: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) RSV-B neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60). ### Secondary outcomes 1. HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains Timeframe: At 1 month after the FLU vaccine dose (Day 31 for both groups) SCR for HI titers was defined as the percentage of participants who have either a HI predose titer less than (\\<) 1:10 and a post-dose titer greater than or equal to (\\>=) 1:40, or a pre-dose titer \\>= 1:10 and at least a 4-fold increase in post-dose titer. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata. 2. RSV-A Neutralizing Titers Expressed as Mean Geometric Increase (MGI) Timeframe: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group) MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. 3. RSV-B Neutralizing Titers Expressed as MGI Timeframe: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group) MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. 4. HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT Timeframe: At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups) HI titers were assessed against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata strains. HI antibodies were expressed as GMTs, in titers. 5. HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains Timeframe: At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups) SPR for HI titers was defined as the percentage of participants with a serum HI titer \\>= 1:40\. The assessed Flu strains were: The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata. 6. HI Titers for 4 FLU Vaccine Strains, Expressed as MGI Timeframe: At 1 month after the FLU vaccine dose administration (Day 31 for both groups) MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. 7. Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration Timeframe: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31) The solicited administration site events after vaccination included erythema, pain and swelling. 8. Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration Timeframe: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31) The solicited systemic events after vaccination include arthralgia, fatigue, fever, headache and myalgia. 9. Percentage of Participants Reporting Unsolicited Adverse Events (AEs) Timeframe: Within 30 days after vaccine administration (the day of vaccination and 29 subsequent days after vaccination) An unsolicited AEs is an AE that is not included in a list of solicited events using a participant diary. Unsolicited events must have been spontaneously communicated by a participant who signs the informed consent. Unsolicited AEs include both serious, non-serious AEs and potential immune-mediated diseases (pIMDs). 10. Percentage of Participants Reporting Serious Adverse Events (SAEs) Timeframe: From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group) An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant. 11. Percentage of Participants Reporting Potential Immune-mediated Disease (pIMDs) Timeframe: From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group) pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. The investigator must exercise his/her medical/scientific judgment to determine whether other diseases have an autoimmune origin (i.e. pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) ## Eligibility **Sex** All **Age groups** Older adults **Minimum age** 65 Years **Healthy volunteers** Yes ### Inclusion criteria - Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol - A male or female ≥65 years of age at the time of the first study intervention administration. - Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living. - Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure. - Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Participants with chronic stable medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable. ### Exclusion criteria Medical conditions - Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required). - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. - Hypersensitivity to latex. - History of Guillain Barré syndrome, or anaphylaxis. - Serious or unstable chronic illness. - Any history of dementia or any medical condition that moderately or severely impairs cognition. - Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g. completion of diary cards, attend regular phone calls/study site visits). - Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. - Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. Prior/Concomitant therapy - Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the first study vaccine administration, or planned use during the study period. - Administration of an influenza vaccine during the 6 months preceding the study FLU vaccine administration. - Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration. Note: In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is recommended and/or organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly. - Previous vaccination with an RSV vaccine. - Administration of long-acting immune-modifying drugs or planned administration at any time during the study period. - Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine or planned administration during the study period. - Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first study vaccination or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed. 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 exclusions - History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. - Planned move during the study conduct that prohibits participation until 1 month post-last vaccine administration. - Bedridden participants. - Participation of any study personnel or their immediate dependents, family, or household members. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) ## Sites - GSK Investigational SiteBirmingham, United States - GSK Investigational SiteTempe, United States - GSK Investigational SiteCanoga Park, United States - GSK Investigational SiteColton, United States - GSK Investigational SiteSacramento, United States - GSK Investigational SiteSan Diego, United States - GSK Investigational SiteWalnut Creek, United States - GSK Investigational SiteAurora, United States - GSK Investigational SiteCoral Gables, United States - GSK Investigational SiteFort Myers, United States - GSK Investigational SiteHialeah, United States - GSK Investigational SiteImmokalee, United States - GSK Investigational SiteMiami, United States - GSK Investigational SiteMiami, United States - GSK Investigational SiteOrlando, United States - GSK Investigational SiteWest Palm Beach, United States - GSK Investigational SiteSandy Springs, United States - GSK Investigational SiteSavannah, United States - GSK Investigational SiteChicago, United States - GSK Investigational SiteEvansville, United States - GSK Investigational SiteMishawaka, United States - GSK Investigational SiteValparaiso, United States - GSK Investigational SiteAmes, United States - GSK Investigational SiteEl Dorado, United States - GSK Investigational SiteMethuen, United States And 21 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) ## References - PubMed 38981954 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/38981954/) Background ### Other registry identifiers - 2021-001356-34 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05559476) ## 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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