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A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RSVPreF3 OA investigational vaccine
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Syncytial Virus Infections focused on measuring Respiratory syncytial virus, Immunogenicity, Safety, Increased risk of respiratory syncytial virus lower respiratory tract disease, Adults aged 50-59 years of age, Older adults 60 years of age and above

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

    1. Specific inclusion criteria for all participants in Cohort 1 (Adults HA-RSV Group, Adults HA-Placebo Group, Adults AIR-RSV Group & Adults AIR-Placebo Group)

  • A male or female participant 50-59 YOA at the time of the study intervention administration.
  • Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause.
  • Female participants of childbearing potential may be enrolled in the study, if the participant:

    • has practiced adequate contraception from 1 month prior to study intervention administration until study end for this study, and
    • has a negative pregnancy test on the day of study intervention administration.

Specific inclusion criteria for participants in the Adults-HA Sub-cohort

  • Healthy participants as established by medical history and clinical examination before entering into the study.
  • Participants with chronic stable medical conditions with or without specific treatment, such as hypertension, hypercholesterolemia, or hypothyroidism, and who are not at increased risk for RSV-LRTD , are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).

Specific inclusion criteria for participants in the Adults-AIR Sub cohort

Participants should be diagnosed with at least 1 of the following medical conditions and have a stable condition (no changes in the treatment or disease severity in the past 3 months):

  • Chronic pulmonary disease resulting in activity restricting symptoms or use of long-term medication
  • Chronic cardiovascular disease
  • Diabetes mellitus: types 1 and 2
  • Other diseases at increased risk for RSV-LRTD disease

    • Chronic kidney disease
    • Chronic liver disease 2. Specific inclusion criteria for Cohort 2 (OA-RSV Group)
  • A male or female participant ≥60 YOA at the time of the study intervention administration.
  • Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).
  • Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.

Exclusion Criteria:

Medical conditions

  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
  • Hypersensitivity to latex.
  • Unstable chronic illness.
  • Any history of dementia or any medical condition that moderately or severely impairs cognition.
  • Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol. Study participants may decide to assign a caregiver to help them complete the study procedures.
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

Prior/Concomitant therapy

  • Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 4, Month 12).
  • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated and subunit influenza vaccines or COVID-19 vaccines (fully licensed or with EUA) which can be administered up to 14 days before or from 14 days after the study intervention administration.

Note: In case an emergency mass vaccination for an unforeseen public health threat is recommended and/or organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.

  • Previous vaccination with an RSV vaccine, including investigational RSV vaccines.
  • Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune modifying treatments or planned administration at any time up to the end of the study.

    • Up to 3 months prior to the study intervention administration:
    • For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
    • Administration of immunoglobulins and/or any blood products or plasma derivatives.
    • Up to 6 months prior to study intervention administration: long-acting immune modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.

Prior/Concurrent clinical study experience

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or invasive medical device).

Other exclusions Other exclusions for all participants

  • 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 participating in the study until study end.
  • Participation of any study personnel or their immediate dependents, family, or household members.

Other exclusions for Cohort 1

  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Adults HA-RSV Group

Adults HA-Placebo Group

Adults AIR-RSV Group

Adults AIR-Placebo Group

OA-RSV Group

Arm Description

Healthy adults (HA) 50-59 YOA, who receive 1 dose of RSVPreF3 OA investigational vaccine at Day 1.

HA 50-59 YOA, who receive 1 dose of placebo at Day 1.

Adults at increased risk (AIR) 50-59 YOA, who receive 1 dose of RSVPreF3 OA investigational vaccine at Day 1.

Adults AIR 50-59 YOA, who receive 1 dose of placebo at Day 1.

Older adults (OA) ≥60 YOA, who receive 1 dose of RSVPreF3 OA investigational vaccine at Day 1.

Outcomes

Primary Outcome Measures

RSV-A neutralization titers expressed as group geometric mean titer (GMT) ratio in healthy participants compared to OA
RSV-A neutralization titers expressed as group seroresponse rate (SRR) difference in healthy participants compared to OA
RSV-B neutralization titers expressed as group GMT ratio in healthy participants compared to OA
RSV-B neutralization titers expressed as group SRR difference in healthy participants compared to OA
RSV-A neutralization titers expressed as group GMT ratio in participants at increased risk of RSV-LRTD compared to OA
RSV-A neutralization titers expressed as group SRR difference in participants at increased risk of RSV-LRTD compared to OA
RSV-B neutralization titers expressed as group GMT ratio in participants at increased risk of RSV-LRTD compared to OA
RSV-B neutralization titers expressed as group SRR difference in participants at increased risk of RSV-LRTD compared to OA

Secondary Outcome Measures

Percentage of participants reporting each solicited administration site event (pain, redness and swelling)
Percentage of participants reporting each solicited systemic event (fever, headache, muscle pain, joint pain, tiredness)
Percentage of participants reporting unsolicited adverse events (AEs)
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Percentage of participants reporting any serious adverse events (SAEs)
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, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
Percentage of participants reporting any potential immune mediated diseases (pIMDs)
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.
Percentage of participants reporting SAEs related to study intervention administration
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, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
Percentage of participants reporting pIMDs related to study intervention administration
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.
Percentage of participants reporting any fatal SAEs
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, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
RSV-A neutralization titers expressed as GMT
RSV-B neutralization titers expressed as GMT
Frequency of RSVPreF3-specific cluster of differentiation (CD)4+ T cells expressing at least 2 activation markers
Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), 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.
Frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers
Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

Full Information

First Posted
October 18, 2022
Last Updated
July 27, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT05590403
Brief Title
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above
Official Title
A Phase 3, Observer-blind, Randomized, Placebo-controlled Study to Evaluate the Non-inferiority of the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults ≥60 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
March 13, 2023 (Actual)
Study Completion Date
February 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD), versus adults ≥60 YOA

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
Respiratory syncytial virus, Immunogenicity, Safety, Increased risk of respiratory syncytial virus lower respiratory tract disease, Adults aged 50-59 years of age, Older adults 60 years of age and above

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Observer-blind for Cohort 1 (Day1-Day 31) and single-blind afterwards and open-label for Cohort 2
Allocation
Randomized
Enrollment
1576 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adults HA-RSV Group
Arm Type
Experimental
Arm Description
Healthy adults (HA) 50-59 YOA, who receive 1 dose of RSVPreF3 OA investigational vaccine at Day 1.
Arm Title
Adults HA-Placebo Group
Arm Type
Placebo Comparator
Arm Description
HA 50-59 YOA, who receive 1 dose of placebo at Day 1.
Arm Title
Adults AIR-RSV Group
Arm Type
Experimental
Arm Description
Adults at increased risk (AIR) 50-59 YOA, who receive 1 dose of RSVPreF3 OA investigational vaccine at Day 1.
Arm Title
Adults AIR-Placebo Group
Arm Type
Placebo Comparator
Arm Description
Adults AIR 50-59 YOA, who receive 1 dose of placebo at Day 1.
Arm Title
OA-RSV Group
Arm Type
Experimental
Arm Description
Older adults (OA) ≥60 YOA, who receive 1 dose of RSVPreF3 OA investigational vaccine at Day 1.
Intervention Type
Biological
Intervention Name(s)
RSVPreF3 OA investigational vaccine
Intervention Description
One dose administered intramuscularly at Day 1.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One dose administered intramuscularly at Day 1.
Primary Outcome Measure Information:
Title
RSV-A neutralization titers expressed as group geometric mean titer (GMT) ratio in healthy participants compared to OA
Time Frame
1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
Title
RSV-A neutralization titers expressed as group seroresponse rate (SRR) difference in healthy participants compared to OA
Time Frame
1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
Title
RSV-B neutralization titers expressed as group GMT ratio in healthy participants compared to OA
Time Frame
1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
Title
RSV-B neutralization titers expressed as group SRR difference in healthy participants compared to OA
Time Frame
1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
Title
RSV-A neutralization titers expressed as group GMT ratio in participants at increased risk of RSV-LRTD compared to OA
Time Frame
1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
Title
RSV-A neutralization titers expressed as group SRR difference in participants at increased risk of RSV-LRTD compared to OA
Time Frame
1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
Title
RSV-B neutralization titers expressed as group GMT ratio in participants at increased risk of RSV-LRTD compared to OA
Time Frame
1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
Title
RSV-B neutralization titers expressed as group SRR difference in participants at increased risk of RSV-LRTD compared to OA
Time Frame
1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
Secondary Outcome Measure Information:
Title
Percentage of participants reporting each solicited administration site event (pain, redness and swelling)
Time Frame
Within 4 days after study intervention administered on Day 1
Title
Percentage of participants reporting each solicited systemic event (fever, headache, muscle pain, joint pain, tiredness)
Time Frame
Within 4 days after study intervention administered at Day 1
Title
Percentage of participants reporting unsolicited adverse events (AEs)
Description
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Time Frame
Within 30 days after study intervention administered at Day 1
Title
Percentage of participants reporting any serious adverse events (SAEs)
Description
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, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
Time Frame
After study intervention administration (Day 1) up to Month 6
Title
Percentage of participants reporting any potential immune mediated diseases (pIMDs)
Description
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.
Time Frame
After study intervention administration (Day 1) up to Month 6
Title
Percentage of participants reporting SAEs related to study intervention administration
Description
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, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
Time Frame
After study intervention administration (Day 1) up to study end (Month 12)
Title
Percentage of participants reporting pIMDs related to study intervention administration
Description
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.
Time Frame
After study intervention administration (Day 1) up to study end (Month 12)
Title
Percentage of participants reporting any fatal SAEs
Description
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, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
Time Frame
After study intervention administration (Day 1) up to study end (Month 12)
Title
RSV-A neutralization titers expressed as GMT
Time Frame
At pre-study intervention administration, 1 month, 6 months and at 12 months after study intervention administration
Title
RSV-B neutralization titers expressed as GMT
Time Frame
At pre-study intervention administration, 1 month, 6 months and at 12 months after study intervention administration
Title
Frequency of RSVPreF3-specific cluster of differentiation (CD)4+ T cells expressing at least 2 activation markers
Description
Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), 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.
Time Frame
At pre-study intervention administration, 1 month, 6 months and at 12 months after study intervention administration
Title
Frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers
Description
Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Time Frame
At pre-study intervention administration, 1 month, 6 months and at 12 months after study intervention administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 1. Specific inclusion criteria for all participants in Cohort 1 (Adults HA-RSV Group, Adults HA-Placebo Group, Adults AIR-RSV Group & Adults AIR-Placebo Group) A male or female participant 50-59 YOA at the time of the study intervention administration. Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause. Female participants of childbearing potential may be enrolled in the study, if the participant: has practiced adequate contraception from 1 month prior to study intervention administration until study end for this study, and has a negative pregnancy test on the day of study intervention administration. Specific inclusion criteria for participants in the Adults-HA Sub-cohort Healthy participants as established by medical history and clinical examination before entering into the study. Participants with chronic stable medical conditions with or without specific treatment, such as hypertension, hypercholesterolemia, or hypothyroidism, and who are not at increased risk for RSV-LRTD , are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months). Specific inclusion criteria for participants in the Adults-AIR Sub cohort Participants should be diagnosed with at least 1 of the following medical conditions and have a stable condition (no changes in the treatment or disease severity in the past 3 months): Chronic pulmonary disease resulting in activity restricting symptoms or use of long-term medication Chronic cardiovascular disease Diabetes mellitus: types 1 and 2 Other diseases at increased risk for RSV-LRTD disease Chronic kidney disease Chronic liver disease 2. Specific inclusion criteria for Cohort 2 (OA-RSV Group) A male or female participant ≥60 YOA at the time of the study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months). Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living. Exclusion Criteria: Medical conditions Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required). History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. Hypersensitivity to latex. Unstable chronic illness. Any history of dementia or any medical condition that moderately or severely impairs cognition. Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol. Study participants may decide to assign a caregiver to help them complete the study procedures. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. Prior/Concomitant therapy Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 4, Month 12). Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated and subunit influenza vaccines or COVID-19 vaccines (fully licensed or with EUA) which can be administered up to 14 days before or from 14 days after the study intervention administration. Note: In case an emergency mass vaccination for an unforeseen public health threat is recommended and/or organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly. Previous vaccination with an RSV vaccine, including investigational RSV vaccines. Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune modifying treatments or planned administration at any time up to the end of the study. Up to 3 months prior to the study intervention administration: For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed. Administration of immunoglobulins and/or any blood products or plasma derivatives. Up to 6 months prior to study intervention administration: long-acting immune modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication. Prior/Concurrent clinical study experience • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or invasive medical device). Other exclusions Other exclusions for all participants 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 participating in the study until study end. Participation of any study personnel or their immediate dependents, family, or household members. Other exclusions for Cohort 1 Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions.
Facility Information:
Facility Name
GSK Investigational Site
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
GSK Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
GSK Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
GSK Investigational Site
City
Immokalee
State/Province
Florida
ZIP/Postal Code
34142
Country
United States
Facility Name
GSK Investigational Site
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46544
Country
United States
Facility Name
GSK Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
GSK Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
GSK Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
GSK Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
GSK Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
GSK Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75224
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
GSK Investigational Site
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
GSK Investigational Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1426BOF
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1425AZE
Country
Argentina
Facility Name
GSK Investigational Site
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Facility Name
GSK Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6R3
Country
Canada
Facility Name
GSK Investigational Site
City
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N 1L2
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
GSK Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 2G2
Country
Canada
Facility Name
GSK Investigational Site
City
St-Charles-Borromée
State/Province
Quebec
ZIP/Postal Code
J6E 2B4
Country
Canada
Facility Name
GSK Investigational Site
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G9A 4P3
Country
Canada
Facility Name
GSK Investigational Site
City
Weinheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69469
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80339
Country
Germany
Facility Name
GSK Investigational Site
City
Wallerfing
State/Province
Bayern
ZIP/Postal Code
94574
Country
Germany
Facility Name
GSK Investigational Site
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97070
Country
Germany
Facility Name
GSK Investigational Site
City
Stuhr
State/Province
Niedersachsen
ZIP/Postal Code
28816
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45359
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55116
Country
Germany
Facility Name
GSK Investigational Site
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
145-0063
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
155-0031
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
170-0003
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
192-0918
Country
Japan
Facility Name
GSK Investigational Site
City
Den Haag
ZIP/Postal Code
2572 GM
Country
Netherlands
Facility Name
GSK Investigational Site
City
Groningen
ZIP/Postal Code
9713 AG
Country
Netherlands
Facility Name
GSK Investigational Site
City
Zwijndrecht
ZIP/Postal Code
3334 SB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
GSK Investigational Site
City
Katowice
ZIP/Postal Code
40-648
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-559
Country
Poland
Facility Name
GSK Investigational Site
City
Piaseczno
ZIP/Postal Code
05-500
Country
Poland
Facility Name
GSK Investigational Site
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
GSK Investigational Site
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Facility Name
GSK Investigational Site
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
GSK Investigational Site
City
Centelles (Barcelona)
ZIP/Postal Code
08540
Country
Spain
Facility Name
GSK Investigational Site
City
Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
GSK Investigational Site
City
Pama de Mallorca
ZIP/Postal Code
07010
Country
Spain
Facility Name
GSK Investigational Site
City
Vigo
ZIP/Postal Code
36312
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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, a 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.

Learn more about this trial

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above

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