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

A 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

The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 3 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Biological: RSVPreF3 OA investigational vaccine

• Study Type: Interventional
• Enrollment (Actual): 1720
• Phase: Phase 3

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland, 02230
    • GSK Investigational Site
  • Helsinki, Finland, 00100
    • GSK Investigational Site
  • Helsinki, Finland, 00930
    • GSK Investigational Site
  • Jarvenpaa, Finland, 04400
    • GSK Investigational Site
  • Kokkola, Finland, 67100
    • GSK Investigational Site
  • Oulu, Finland, 90220
    • GSK Investigational Site
  • Pori, Finland, 28100
    • GSK Investigational Site
  • Seinajoki, Finland, 60100
    • GSK Investigational Site
  • Tampere, Finland, 33100
    • GSK Investigational Site
  • Turku, Finland, 20520
    • GSK Investigational Site
• Germany
  • Hamburg, Germany, 22143
    • GSK Investigational Site
  • Bayern
    • Muenchen, Bayern, Germany, 80339
      • GSK Investigational Site
    • Wallerfing, Bayern, Germany, 94574
      • GSK Investigational Site
    • Wuerzburg, Bayern, Germany, 97074
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45355
      • GSK Investigational Site
    • Essen, Nordrhein-Westfalen, Germany, 45359
      • GSK Investigational Site
    • Goch, Nordrhein-Westfalen, Germany, 47574
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55116
      • GSK Investigational Site
• Japan
  • Fukuoka, Japan, 812-0025
    • GSK Investigational Site
  • Kumamoto, Japan, 861-4157
    • GSK Investigational Site
  • Tokyo, Japan, 160-0017
    • GSK Investigational Site
• Taiwan
  • Changhua, Taiwan, 500
    • GSK Investigational Site
  • Taichung, Taiwan, 40447
    • GSK Investigational Site
  • Taichung, Taiwan, 407
    • GSK Investigational Site
  • Taipei, Taiwan, 100
    • GSK Investigational Site
  • Taipei, Taiwan, 104
    • GSK Investigational Site
  • Taipei, Taiwan, 112
    • GSK Investigational Site
  • Taoyuan County, Taiwan, 333
    • GSK Investigational Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • GSK Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • GSK Investigational Site
  • California
    • Riverside, California, United States, 92503
      • GSK Investigational Site
    • San Diego, California, United States, 92103
      • GSK Investigational Site
  • Florida
    • Coral Gables, Florida, United States, 33134
      • GSK Investigational Site
    • Fort Myers, Florida, United States, 33912
      • GSK Investigational Site
    • Sarasota, Florida, United States, 34243
      • GSK Investigational Site
    • The Villages, Florida, United States, 32162
      • GSK Investigational Site
  • Indiana
    • Evansville, Indiana, United States, 47714
      • GSK Investigational Site
  • Kansas
    • Wichita, Kansas, United States, 67207
      • GSK Investigational Site
  • Minnesota
    • Richfield, Minnesota, United States, 55423
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • GSK Investigational Site
  • New York
    • Rochester, New York, United States, 14609
      • GSK Investigational Site
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • GSK Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • GSK Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • GSK Investigational Site
  • Washington
    • Wenatchee, Washington, United States, 98801
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 the study end (Month 60).	Biological: RSVPreF3 OA investigational vaccine; RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Experimental: 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 the study end (Month 60).	Biological: RSVPreF3 OA investigational vaccine; RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Experimental: 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 and RSV_1dose_flexible groups), which will be followed up until the study end (Month 60).	Biological: RSVPreF3 OA investigational vaccine; RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At Day 1
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.	At Day 31
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.	At Month 6
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.	At Month 12
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.	At Day 1
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.	At Day 31
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.	At Month 6
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.	At Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At Day 1
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.	At Day 31
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.	At Month 6
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.	At Month 12
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).	At Month 18
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).	At Month 24
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).	At Month 30
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).	At Month 36
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).	At Month 13
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).	At Month 25
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).	At Month 18
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).	At Month 24
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).	At Month 30
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).	At Month 36
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).	At Month 13
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).	At Month 25
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.	At Month 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.	At Month 24
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.	At Month 30
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.	At Month 36
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.	At Month 13
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.	At Month 25
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.	At Day 1
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.	At Day 1
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.	At Day 31
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.	At Day 31
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.	At Month 6
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.	At Month 6
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.	At Month 12
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.	At Month 12
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.	At Month 18
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.	At Month 18
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.	At Month 24
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.	At Month 24
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.	At Month 30
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.	At Month 30
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.	At Month 36
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.	At Month 36
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.	At Month 13
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.	At Month 13
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.	At Month 25
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.	At Month 25
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.	During the 4-day follow up period after first vaccination (vaccine administered on Day 1)
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.	During the 4-day follow up period after vaccination (vaccine administered at Month 12)
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.	During the 4-day follow up period after vaccination (vaccine administered at Month 24)
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.	During the 4-day follow up period after vaccination (vaccine administered on Day 1)
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.	During the 4-day follow up period after vaccination (vaccine administered at Month 12)
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.	During the 4-day follow up period after vaccination (vaccine administered at Month 24)
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.	During the 30-day follow up period after vaccination (vaccine administered on Day 1)
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.	During the 4-day follow up period after vaccination (vaccine administered at Month 12)
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.	During the 4-day follow up period after vaccination (vaccine administered at Month 24)
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.	From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6)
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.	During the 4-day follow up period after vaccination (vaccine administered at Month 12)
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.	During the 4-day follow up period after vaccination (vaccine administered at Month 24)
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.	From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6)
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.	During the 4-day follow up period after vaccination (vaccine administered at Month 12)
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.	During the 4-day follow up period after vaccination (vaccine administered at Month 24)
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.	From first vaccination (Day 1) up to study end (Month 36)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): June 6, 2022
• Study Completion (Estimated): May 25, 2026

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Vaccine; Immunogenicity; Respiratory syncytial virus; Reactogenicity
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: 212496; 2019-004680-51 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No