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

• ClinicalTrials.gov Identifier: NCT04732871
• Recruitment Status: Active, not recruiting
• First Posted: February 1, 2021
• Last Update Posted: July 25, 2022
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Syncytial Virus Infections	Biological: RSVPreF3 OA investigational vaccine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1720 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: Open-label study. Both investigator and participant know the identity of the intervention assigned.
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: February 15, 2021
• Actual Primary Completion Date: June 14, 2022
• Estimated Study Completion Date: May 24, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group A; 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.	Biological: RSVPreF3 OA investigational vaccine; RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Experimental: Group B; Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and are followed up until the study end.	Biological: RSVPreF3 OA investigational vaccine; RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Experimental: Group C; Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until the study end.	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 RSV-A neutralizing antibody Geometric Mean Titers (GMTs) [ Time Frame: At Day 1 (pre-vaccination) ]
   RSV-A neutralizing antibodies are 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 [ Time Frame: At Day 31 ]
   RSV-A neutralizing antibodies are 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)
3. Humoral immune response in terms of RSV-A neutralizing antibody GMTs [ Time Frame: At Month 6 ]
   RSV-A neutralizing antibodies are 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)
4. Humoral immune response in terms of RSV-A neutralizing antibody GMTs [ Time Frame: At Month 12 ]
   RSV-A neutralizing antibodies are 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)
5. Humoral immune response in terms of RSV-B neutralizing antibody titers [ Time Frame: At Day 1 (pre-vaccination) ]
   RSV-B neutralizing antibodies are 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-B neutralizing antibody titers [ Time Frame: At Day 31 ]
   RSV-B neutralizing antibodies are 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-B neutralizing antibody titers [ Time Frame: At Month 6 ]
   RSV-B neutralizing antibodies are 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-B neutralizing antibody titers [ Time Frame: At Month 12 ]
   RSV-B neutralizing antibodies are 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)

Secondary Outcome Measures :

1. Humoral immune response in terms of RSVPreF3 Immunoglobulin G (IgG) antibody geometric mean concentrations (GMCs) [ Time Frame: At Day 1 (pre-vaccination) ]
   Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by enzyme-linked immunosorbent assay (ELISA). The corresponding antibody GMC is expressed in Elisa Laboratory Units/milliliter (ELU/mL).
2. Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [ Time Frame: At Day 31 ]
   Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
3. Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [ Time Frame: At Month 6 ]
   Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
4. Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [ Time Frame: At Month 12 ]
   Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
5. Humoral immune response in terms of RSV-A neutralizing antibody GMTs [ Time Frame: At Month 18 ]
   RSV-A neutralizing antibodies are 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 [ Time Frame: At Month 24 ]
   RSV-A neutralizing antibodies are 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 [ Time Frame: At Month 30 ]
   RSV-A neutralizing antibodies are 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 [ Time Frame: At Month 36 ]
   RSV-A neutralizing antibodies are 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 [ Time Frame: At Month 13 ]
   RSV-A neutralizing antibodies are 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 [ Time Frame: At Month 25 ]
    RSV-A neutralizing antibodies are 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 [ Time Frame: At Month 18 ]
    RSV-B neutralizing antibodies are 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 [ Time Frame: At Month 24 ]
    RSV-B neutralizing antibodies are 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 [ Time Frame: At Month 30 ]
    RSV-B neutralizing antibodies are 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 [ Time Frame: At Month 36 ]
    RSV-B neutralizing antibodies are 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 [ Time Frame: At Month 13 ]
    RSV-B neutralizing antibodies are 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 [ Time Frame: At Month 25 ]
    RSV-B neutralizing antibodies are 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 [ Time Frame: At Month 18 ]
    Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
18. Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [ Time Frame: At Month 24 ]
    Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
19. Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [ Time Frame: At Month 30 ]
    Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
20. Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [ Time Frame: At Month 36 ]
    Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
21. Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [ Time Frame: At Month 13 ]
    Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
22. Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [ Time Frame: At Month 25 ]
    Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
23. CMI response in terms of frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ and/or CD8+ T cells expressing at least 2 activation markers [ Time Frame: At Day 1(pre-vaccination) ]
    Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour 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 CD4+ and/or CD8+ T cells expressing at least 2 activation markers [ Time Frame: At Day 31 ]
    Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
25. CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [ Time Frame: At Month 6 ]
    Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
26. CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [ Time Frame: At Month 12 ]
    Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
27. CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [ Time Frame: At Month 18 ]
    Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
28. CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [ Time Frame: At Month 24 ]
    Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
29. CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [ Time Frame: At Month 30 ]
    Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
30. CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [ Time Frame: At Month 36 ]
    Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
31. CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [ Time Frame: At Month 13 ]
    Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour 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 CD4+ and/or CD8+ T cells expressing at least 2 activation markers [ Time Frame: At Month 25 ]
    Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
33. Number of participants with at least one solicited administration-site event and solicited systemic event [ Time Frame: During the 4 days (including the day of vaccination) following vaccination at Day 1 ]
    The solicited administration-site events are pain, erythema and swelling at the injection site. The solicited systemic events include fever (defined as temperature equal to or above 38.0 degree Celsius (°C)), headache, fatigue, myalgia and arthralgia.
34. Number of participants with at least one solicited administration-site event and solicited systemic event [ Time Frame: During the 4 days (including the day of vaccination) following vaccination at Month 12 ]
    The solicited administration-site events are pain, erythema and swelling at the injection site. The solicited systemic events include fever (defined as temperature equal to or above 38.0 degree Celsius (°C)), headache, fatigue, myalgia and arthralgia.
35. Number of participants with at least one solicited administration-site event and solicited systemic event [ Time Frame: During the 4 days (including the day of vaccination) following vaccination at Month 24. ]
    The solicited administration-site events are pain, erythema and swelling at the injection site. The solicited systemic events include fever (defined as temperature equal to or above 38.0 degree Celsius (°C)), headache, fatigue, myalgia and arthralgia.
36. Number of participants with any unsolicited adverse events (AEs) [ Time Frame: During the 30 days (including the day of vaccination) 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.
37. Number of participants with any unsolicited AEs [ Time Frame: During the 30 days (including the day of vaccination) following vaccination at Month 12 ]
    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.
38. Number of participants with any unsolicited AEs [ Time Frame: During the 30 days (including the day of vaccination) following vaccination at Month 24 ]
    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.
39. Number of participants with serious adverse events (SAE) [ Time Frame: From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6) ]
    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.
40. Number of participants with SAEs [ Time Frame: From revaccination (Month 12) up to 6 months post-revaccination (Month 18) ]
    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.
41. Number of participants with SAEs [ Time Frame: From revaccination (Month 24) up to 6 months post-revaccination (Month 30) ]
    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.
42. Number of participants reporting any potential immune-mediated disease (pIMD) [ Time Frame: From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6) ]
    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.
43. Number of participants reporting any pIMD [ Time Frame: From revaccination (Month 12) up to 6 months post-revaccination (Month 18) ]
    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.
44. Number of participants reporting any pIMD [ Time Frame: From revaccination (Month 24) up to 6 months post-revaccination (Month 30) ]
    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.
45. Number of participants with a fatal SAE, related SAE and related pIMDs [ Time Frame: From first vaccination (Day 1) up to study end (Month 36) ]
    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

Eligibility Criteria

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

Criteria

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

Locations

United States, Alabama

GSK Investigational Site

Mobile, Alabama, United States, 36608

United States, Arizona

GSK Investigational Site

Phoenix, Arizona, United States, 85020

United States, California

GSK Investigational Site

Riverside, California, United States, 92503

GSK Investigational Site

San Diego, California, United States, 92103

United States, Florida

GSK Investigational Site

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

United States, Indiana

GSK Investigational Site

Evansville, Indiana, United States, 47714

United States, Kansas

GSK Investigational Site

Wichita, Kansas, United States, 67207

United States, Minnesota

GSK Investigational Site

Richfield, Minnesota, United States, 55423

United States, Missouri

GSK Investigational Site

Kansas City, Missouri, United States, 64114

United States, New York

GSK Investigational Site

Rochester, New York, United States, 14609

United States, South Carolina

GSK Investigational Site

Mount Pleasant, South Carolina, United States, 29464

GSK Investigational Site

Spartanburg, South Carolina, United States, 29303

United States, Texas

GSK Investigational Site

San Antonio, Texas, United States, 78229

United States, Virginia

GSK Investigational Site

Norfolk, Virginia, United States, 23502

United States, Washington

GSK Investigational Site

Wenatchee, Washington, United States, 98801

Finland

GSK Investigational Site

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

Germany

GSK Investigational Site

Muenchen, Bayern, Germany, 80339

GSK Investigational Site

Wallerfing, Bayern, Germany, 94574

GSK Investigational Site

Wuerzburg, Bayern, Germany, 97074

GSK Investigational Site

Essen, Nordrhein-Westfalen, Germany, 45355

GSK Investigational Site

Essen, Nordrhein-Westfalen, Germany, 45359

GSK Investigational Site

Goch, Nordrhein-Westfalen, Germany, 47574

GSK Investigational Site

Mainz, Rheinland-Pfalz, Germany, 55116

GSK Investigational Site

Hamburg, Germany, 22143

Japan

GSK Investigational Site

Fukuoka, Japan, 812-0025

GSK Investigational Site

Kumamoto, Japan, 861-4157

GSK Investigational Site

Tokyo, Japan, 160-0017

Taiwan

GSK Investigational Site

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

Sponsors and Collaborators

GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT04732871
• Other Study ID Numbers: 212496; 2019-004680-51 ( EudraCT Number )
• First Posted: February 1, 2021
• Last Update Posted: July 25, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• 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.
• 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.

• 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

Keywords provided by GlaxoSmithKline:

Respiratory syncytial virus; Vaccine; Safety; Reactogenicity; Immunogenicity

Additional relevant MeSH terms:

Respiratory Syncytial Virus Infections; Virus Diseases; Infections; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections