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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04732871
Recruitment Status : Active, not recruiting
First Posted : February 1, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

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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
Estimated Primary Completion Date : May 24, 2022
Estimated Study Completion Date : May 24, 2024

Resource links provided by the National Library of Medicine


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 are followed up until the study end. A revaccination dose may be given whenever revaccination would be needed
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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04732871


Locations
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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, 97070
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 City, Taiwan, 11217
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 104
GSK Investigational Site
Taoyuan County, Taiwan, 333
Sponsors and Collaborators
GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04732871    
Other Study ID Numbers: 212496
2019-004680-51 ( EudraCT Number )
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
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 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.

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