Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)Verified February 2026 by GlaxoSmithKline
Sponsor
GlaxoSmithKline
Information Provided by (Responsible Party)
GlaxoSmithKline
Clinicaltrials.gov Identifier
NCT04732871
Other Study ID Numbers:
212496
First Submitted
January 26, 2021
First Posted
January 31, 2021
Results First Posted
October 24, 2023
Last Update Posted
March 19, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Respiratory Syncytial Virus Infections
Biological: RSVPreF3 OA investigational vaccineBiological: RSVPreF3 OA investigational vaccineBiological: RSVPreF3 OA investigational vaccine

Study Design

Study TypeInterventional
Actual Enrollment1720 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposePrevention
Official TitleA Phase 3, Randomized, Open-label, Multi-country Study to Evaluate the Immunogenicity, Safety, Reactogenicity and Persistence of a Single Dose of the RSVPreF3 OA Investigational Vaccine and Different Revaccination Schedules in Adults Aged 60 Years and Above
Study Start DateFebruary 14, 2021
Actual Primary Completion DateJune 5, 2022
Actual Study Completion Date8mos 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
RSV_annual Group
Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and are followed up until Month 60.
Biological: RSVPreF3 OA investigational vaccine
RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
RSV_Flexible revaccination Group
Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 24 months post-Dose 1 and at 48 months post-Dose 1, respectively and are followed up until Month 60.
Biological: RSVPreF3 OA investigational vaccine
RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
RSV_1dose Group
Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until Month 36. At Month 36, participants in this group will be re-randomized in 2 groups: RSV\_1dose\_M36 (which will receive 1 additional revaccination dose at Month 36 and will be followed up until Month 60) and RSV\_1dose\_Flexible (which will receive 1 additional revaccination dose at Month 60, and will be followed up until study end at Month 72).
Biological: RSVPreF3 OA investigational vaccine
RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Outcome Measures

Primary Outcome Measures
  1. Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1
    RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
  2. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31
    RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.
  3. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6
    RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.
  4. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12
    RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.
  5. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1
    RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
  6. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31
    RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
  7. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6
    RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
  8. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12
    RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
Secondary Outcome Measures
  1. Humoral Immune Response in Terms of RSVPreF3 Immunoglobulin G (IgG) Antibody Geometric Mean Concentrations (GMCs) at Day 1
    Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by enzyme-linked immunosorbent assay (ELISA). The corresponding antibody GMC was expressed in Elisa Laboratory Units/milliliter (ELU/mL).
  2. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Day 31
    Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
  3. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 6
    Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
  4. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 12
    Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
  5. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 18
    Month 18 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
  6. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 24
    Month 24 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
  7. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 30
    Month 30 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
  8. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 36
    Month 36 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
  9. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 13
    Month 13 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
  10. Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 25
    Month 25 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
  11. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 18
    Month 18 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
  12. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 24
    Month 24 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
  13. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 30
    Month 30 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
  14. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 36
    Month 36 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
  15. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 13
    Month 13 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
  16. Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 25
    Month 25 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
  17. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 18
    Month 18 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
  18. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 24
    Month 24 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
  19. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 30
    Month 30 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
  20. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 36
    Month 36 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
  21. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 13
    Month 13 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
  22. Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 25
    Month 25 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
  23. Cell-Mediated Immunity (CMI) Response in Terms of Frequency of RSVPreF3-specific Cluster of Differentiation CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1
    Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
  24. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1
    Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
  25. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31
    Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
  26. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31
    Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
  27. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6
    Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
  28. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6
    Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
  29. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12
    Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
  30. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12
    Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
  31. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 18
    Month 18 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
  32. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 18
    Month 18 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
  33. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 24
    Month 24 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
  34. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 24
    Month 24 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
  35. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 30
    Month 30 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
  36. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 30
    Month 30 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
  37. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 36
    Month 36 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
  38. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 36
    Month 36 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
  39. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13
    Month 13 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
  40. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13
    Month 13 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
  41. CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 25
    Month 25 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
  42. CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 25
    Month 25 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
  43. Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1
    The solicited administration-site events were erythema, pain and swelling at the injection site.
  44. Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Month 12
    Month 12 to Month 18 data will be disclosed during final posting. The solicited administration-site events were erythema, pain and swelling at the injection site.
  45. Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Month 24
    Month 24 data will be disclosed during final posting. The solicited administration-site events were erythema, pain and swelling at the injection site.
  46. Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1
    The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0 degree Celsius \[°C\]), headache and myalgia.
  47. Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Month 12
    Month 12 to Month 18 data will be disclosed during final posting. The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0°C), headache and myalgia.
  48. Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Month 24
    Month 24 data will be disclosed during final posting. The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0 degree Celsius (°C)), headache and myalgia.
  49. Number of Participants With Any Unsolicited Adverse Events (AEs) Following Vaccination at Day 1
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
  50. Number of Participants With Any Unsolicited AEs Following Vaccination at Month 12
    Month 12 to Month 18 data will be disclosed during final posting. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
  51. Number of Participants With Any Unsolicited AEs Following Vaccination at Month 24
    Month 24 data will be disclosed during final posting. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
  52. Number of Participants With Serious Adverse Events (SAE) Following Vaccination at Day 1
    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, or is a congenital anomaly/birth defect in the offspring of a study participant.
  53. Number of Participants With SAEs Following Vaccination at Month 12
    Month 12 to Month 18 data will be disclosed during final posting. 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, or is a congenital anomaly/birth defect in the offspring of a study participant.
  54. Number of Participants With SAEs Following Vaccination at Month 24
    Month 24 data will be disclosed during final posting. 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, or is a congenital anomaly/birth defect in the offspring of a study participant.
  55. Number of Participants Reporting Any Potential Immune-mediated Disease (pIMD) Following Vaccination at Day 1
    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.
  56. Number of Participants Reporting Any pIMD Following Vaccination at Month 12
    Month 12 to Month 18 data will be disclosed during final posting. 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.
  57. Number of Participants Reporting Any pIMD Following Vaccination at Month 24
    Month 24 data will be disclosed during final posting. 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.
  58. Number of Participants With a Fatal SAE, Related SAE and Related pIMDs
    A fatal SAE is any untoward medical occurrence that results in death. A related SAE is an SAE considered to be causally related to the study intervention. A related pIMD is a pIMD considered to be causally related to the study intervention. The study is ongoing at the time of the results posting. Results for Months 18 up to study end (Month 36) will be updated during final posting.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Inclusion Criteria
Male or female participants ≥60 YOA at first vaccination, who live in the community (CD participants) or in a Long-term care facility (LTCF participants).
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
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. Patients 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.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Hypersensitivity to latex.
Serious or unstable chronic illness.
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.
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.
Any history of dementia or any medical condition that moderately or severely impairs cognition. Prior/Concomitant therapy
Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or planned use during the study period.
Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated, split virion and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination.
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 vaccine 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. 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 period that will prohibit participation in the trial until the study end. This includes:
Planned move during the study period to another LTCF that will prohibit participation in the trial until study end.
Planned move from the community to a LTCF that will prohibit participation in the trial until study end.
Participation of any study personnel or their immediate dependants, family, or household members.

Contacts and Locations

Sponsors and CollaboratorsGlaxoSmithKline
Locations
GSK Investigational Site | Mobile Alabama, United States, 36608GSK Investigational Site | Phoenix Arizona, United States, 85020GSK Investigational Site | Riverside California, United States, 92503GSK Investigational Site | San Diego California, United States, 92103GSK Investigational Site | Coral Gables Florida, United States, 33134GSK Investigational Site | Fort Myers Florida, United States, 33912GSK Investigational Site | Sarasota Florida, United States, 34243GSK Investigational Site | The Villages Florida, United States, 32162GSK Investigational Site | Evansville Indiana, United States, 47714GSK Investigational Site | Wichita Kansas, United States, 67226GSK Investigational Site | Richfield Minnesota, United States, 55423GSK Investigational Site | Kansas City Missouri, United States, 64114GSK Investigational Site | Rochester New York, United States, 14609GSK Investigational Site | Mt. Pleasant South Carolina, United States, 29464GSK Investigational Site | Spartanburg South Carolina, United States, 29303GSK Investigational Site | San Antonio Texas, United States, 78229GSK Investigational Site | Norfolk Virginia, United States, 23502GSK Investigational Site | Wenatchee Washington, United States, 98801GSK Investigational Site | Espoo , Finland, 02230GSK Investigational Site | Helsinki , Finland, 00100GSK Investigational Site | Helsinki , Finland, 00930GSK Investigational Site | Jarvenpaa , Finland, 04400GSK Investigational Site | Kokkola , Finland, 67100GSK Investigational Site | Oulu , Finland, 90220GSK Investigational Site | Pori , Finland, 28100GSK Investigational Site | Seinäjoki , Finland, 60100GSK Investigational Site | Tampere , Finland, 33100GSK Investigational Site | Turku , Finland, 20520GSK Investigational Site | Essen , Germany, 45355GSK Investigational Site | Essen , Germany, 45359GSK Investigational Site | Goch , Germany, 47574GSK Investigational Site | Hamburg , Germany, 22143GSK Investigational Site | Mainz , Germany, 55116GSK Investigational Site | München , Germany, 80339GSK Investigational Site | Wallerfing , Germany, 94574GSK Investigational Site | Würzburg , Germany, 97074GSK Investigational Site | Fukuoka , Japan, 812-0025GSK Investigational Site | Kumamoto , Japan, 861-4157GSK Investigational Site | Changhua , Taiwan, 500GSK Investigational Site | Taichung , Taiwan, 40447GSK Investigational Site | Taichung , Taiwan, 407GSK Investigational Site | Taipei , Taiwan, 100GSK Investigational Site | Taipei , Taiwan, 104GSK Investigational Site | Taipei , Taiwan, 112GSK Investigational Site | Taoyuan , Taiwan, 333
Study Documents (Full Text)
Documents provided by GlaxoSmithKline: Study Protocol  March 31, 2022Documents provided by GlaxoSmithKline: Statistical Analysis Plan  March 26, 2023