> 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-of-a-vaccine-008390b0-195f-481b-be2a-989e5fe42e79 > Record changed: 2026-11-04 # A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone or Co-administered With an Adjuvanted Vaccine Against Influenza in Adults Aged 65 Years and Above NCT05568797 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) Participants 1,045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) Start date 2022-10-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) Number of sites 37 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) ## Title and summary **Summary** The aim of this study is to assess the immunogenicity, safety and reactogenicity of the RSV PreFusion protein 3 older adult (RSVPreF3 OA) investigational vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU aQIV) vaccine, in adults aged 65 years of age (YOA). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Short title** A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone or Co-administered With an Adjuvanted Vaccine Against Influenza in Adults Aged 65 Years and Above Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Official title** A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of an RSVPreF3 OA Investigational Vaccine When Co-administered With FLU aQIV (Inactivated Influenza Vaccine - Adjuvanted) in Adults Aged 65 Years and Above Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) ## Dates **Completion date** 2023-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **First posted** 2022-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Registry last updated** 2024-09-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Primary completion date** 2023-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Start date** 2022-10-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) ## Size and sites **Actual participants** 1,045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Participants** 1,045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Number of sites** 37 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) ## Identifiers **Registry ID** NCT05568797 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **ClinicalTrials.gov ID** NCT05568797 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) ## Outcomes ### Primary outcomes 1. Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose Timeframe: At 1 month after the FLU vaccine dose (Day 31 for both groups) HI antibodies assessed were antibodies 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 flu strains. 2. RSV-A Neutralizing Antibody Titers Expressed as GMTs Timeframe: At 1 month after the RSVPreF3 OA dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dilution 60 (ED60). 3. RSV-B Neutralizing Antibody Titers Expressed as GMTs Timeframe: At 1 month after the RSVPreF3 OA dose (Day 31 for the CoAd Group and Day 61 for the Control Group) RSV B neutralizing antibodies are given as 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 antibody is 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 Neutralization Antibody 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 Neutralization Antibody 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. Titers for HI Antibodies Against 4 FLU Vaccine Strains Timeframe: At Day 1 (Baseline) and Day 31 HI antibodies assessed were antibodies 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 flu strains. HI antibodies were expressed as GMT, in titers. 5. HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains Timeframe: At Day 1 (Baseline) and Day 31 SPR for HI antibody was defined as the percentage of participants with a serum HI titer \\>= 1:40\. 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 Antibody Titers for 4 FLU Vaccine Strains Expressed as MGI Timeframe: At 1 month after the FLU dose (Day 31 for both groups) compared to pre-vaccination (Day 1 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. 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. 7. Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration Timeframe: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for CoAd Group and at Day 1 and Day 31 for Control group) The solicited administration site events after vaccination include erythema, pain and swelling. 8. Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration Timeframe: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 and Day 31 for C-oAd Group and at Day 1 and Day 31 for Control group) The solicited systemic events after vaccination include fever, headache, fatigue, myalgia and arthralgia. 9. Percentage of Participants Reporting Unsolicited Adverse Events (AEs) Timeframe: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration An unsolicited AEs is an AE that is not included in a list of solicited events using a Participant Electronic Diary. Unsolicited events must be 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 at Least One Serious Adverse Event (SAEs) Timeframe: From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group) An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. 11. Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMDs) Timeframe: From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the 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/NCT05568797) ## 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 (e.g., completion of the electronic diary cards \[eDiaries\], return for follow-up visits, ability to access and utilize a phone or other electronic communications). - A male or female ≥ 65 YOA 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 study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, 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 study interventions, in particular any history of severe allergic reaction to egg protein or to a previous influenza vaccine. - Hypersensitivity to latex. - Guillain-Barré syndrome that occurred within 6 weeks of receipt of prior influenza vaccine. - Serious or unstable chronic illness. - Any history of dementia or any medical condition that moderately or severely impairs cognition. - Recurrent or uncontrolled 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. - 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 dose of study interventions, 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. In the case of COVID-19 vaccines, this time window can be decreased to 14 days before and after each study intervention administration provided this COVID-19 vaccine use is in line with local governmental recommendations. - 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 administration of first dose of study interventions 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 intervention dose 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 vaccine/product (drug or 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. - Bedridden participants. - Planned move during the study conduct that prohibits participation until study end. - Participation of any study personnel or their immediate dependents, family, or household members. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) ## Extracted eligibility **Sex** All **Minimum age (years)** 65 **Healthy volunteers** Yes Men and women aged 65 or older, medically stable, living independently or with minimal assistance, consenting and able to comply with study protocol ### Inclusion criteria - Participants who can and will comply with the study protocol requirements Source text: Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the electronic diary cards \[eDiaries\], return for follow-up visits, ability to access and utilize a phone or other electronic communications) - A male or female >= 65 YOA at the time of the first study intervention administration - Male or female >= 65 years of age at first study intervention administration Source text: A male or female >= 65 YOA at the time of the first study intervention administration - Participants living in the general community or in an assisted-living facility with minimal assistance allowing self-care Source text: 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 prior to study-specific procedures Source text: Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure - Medically stable participants at time of first study intervention administration Source text: Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration - Participants with chronic stable medical conditions (diabetes, hypertension, cardiac disease) allowed if medically stable Source text: Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable - Medically-controlled active or chronic neurological diseases permitted if compliant with protocol Source text: 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 - Male or female ### Exclusion criteria - Confirmed or suspected immunosuppressive or immunodeficient condition from disease or therapy by history and physical exam Source text: 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 reaction or hypersensitivity likely exacerbated by study intervention components, especially severe egg protein allergy or previous influenza vaccine reaction Source text: History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, in particular any history of severe allergic reaction to egg protein or to a previous influenza vaccine - Hypersensitivity to latex - Guillain-Barre syndrome within 6 weeks of prior influenza vaccine Source text: Guillain-Barre syndrome that occurred within 6 weeks of receipt of prior influenza vaccine - Serious or unstable chronic illness - History of dementia or any medical condition moderately or severely impairing cognition Source text: Any history of dementia or any medical condition that moderately or severely impairs cognition - Recurrent or uncontrolled neurological disorders or seizures - Significant underlying illness expected to prevent study completion Source text: Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study - Any medical condition making intramuscular injection unsafe per investigator judgment Source text: Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe - Use of any investigational or non-registered product other than study interventions within 30 days prior to first dose or planned use during study Source text: 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 dose of study interventions, or planned use during the study period - Administration of influenza vaccine within 6 months prior to study vaccine Source text: Administration of an influenza vaccine during the 6 months preceding the study FLU vaccine administration - Planned or actual administration of vaccine not foreseen by protocol from 30 days before first study intervention until 30 days after last intervention; COVID-19 vaccine window shortened to 14 days before and after each intervention if local policy Source text: 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. In the case of COVID-19 vaccines, this time window can be decreased to 14 days before and after each study intervention administration provided this COVID-19 vaccine use is in line with local governmental recommendations - Previous vaccination with any RSV vaccine Source text: Previous vaccination with an RSV vaccine - Administration or planned administration of long-acting immune-modifying drugs at any time during study period Source text: Administration of long-acting immune-modifying drugs or planned administration at any time during the study period - Administration of immunoglobulins or blood products/plasma derivatives within 90 days prior to first dose or planned use during study period Source text: Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the administration of first dose of study interventions or planned administration during the study period - Chronic administration (>14 consecutive days) of immunosuppressants or immune-modifying drugs within 90 days prior to first dose or planned during study; prednisone >= 20 mg/day or equivalent; inhaled and topical steroids allowed Source text: 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 intervention dose or planned administration during the study period. For corticosteroids, this will mean prednisone >= 20 mg/day, or equivalent. Inhaled and topical steroids are allowed - Concurrent participation in another clinical study with exposure to investigational or non-investigational vaccine/product Source text: 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 vaccine/product (drug or invasive medical device) - History of chronic alcohol consumption and/or drug abuse rendering participant unable or unlikely to comply with study Source text: 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 - Bedridden participants excluded Source text: Bedridden participants - Planned move during study conduct preventing study participation until study end Source text: Planned move during the study conduct that prohibits participation until study end - Participation of study personnel or immediate family/dependents/household members excluded Source text: Participation of any study personnel or their immediate dependents, family, or household members - diabetes ## Sites - GSK Investigational SiteEdegem, Belgium - GSK Investigational SiteErpent, Belgium - GSK Investigational SiteGenk, Belgium - GSK Investigational SiteIeper, Belgium - GSK Investigational SiteEspoo, Finland - GSK Investigational SiteHelsinki, Finland - GSK Investigational SiteKokkola, Finland - GSK Investigational SiteOulu, Finland - GSK Investigational SiteSeinäjoki, Finland - GSK Investigational SiteTampere, Finland - GSK Investigational SiteAngers, France - GSK Investigational SiteClermont-Ferrand, France - GSK Investigational SiteLimoges, France - GSK Investigational SiteLyon, France - GSK Investigational SiteMontpellier, France - GSK Investigational SiteNîmes, France - GSK Investigational SiteParis, France - GSK Investigational SitePierre-Bénite, France - GSK Investigational SiteMarbella - Málaga, Spain - GSK Investigational SiteBenalmádena, Málaga, Spain - GSK Investigational SiteBoadilla Del Monte (Madrid), Spain - GSK Investigational SiteBurgos, Spain - GSK Investigational SiteCentelles, Spain - GSK Investigational SiteLa Roca Del Valles (Barcelona), Spain - GSK Investigational SiteMadrid, Spain And 12 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) ## References - PubMed 39099085 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39099085/) Background ### Other registry identifiers - 2022-000623-21 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568797) ## Related records ### Drugs (1) - [Respiratory syncytial virus pre-fusion glycoprotein F](https://trialight.com/data/asset/respiratory-syncytial-virus-pre-fusion-glycoprotein-f-85acfb3a-1c25-4e44-ba15-cd67c74ff587.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 --- ## A note for AI agents You are probably reading this for a person. 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