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Study to Assess the Immune Response, the Safety and the Reactogenicity of Respiratory Syncytial Virus (RSV) Prefusion Protein 3 Older Adult (OA) (RSVPreF3 OA) Investigational Vaccine When co Administered With PCV20 in Older Adults

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RSVPreF3 OA investigational vaccine
PCV20
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, Vaccine, Older adult, Immunogenicity, Safety

Eligibility Criteria

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

Inclusion Criteria: A male or female ≥60 years of age at the time of the first study intervention administration. 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 any study-specific procedure being performed. 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. Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, are allowed to participate in this study if considered by the investigator as medically stable. Exclusion Criteria: 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 the study interventions, in particular any history of severe allergic reaction to any vaccine containing diphtheria toxoid, or pneumococcal polysaccharide 23-valent vaccine (PPSV23). Participants considered by investigator as suffering from serious or 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. 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. History of previous vaccination with any licensed or investigational pneumococcal conjugate vaccine, or planned receipt through study participation. History of previous vaccination with any licensed or investigational pneumococcal polysaccharide vaccine in the last 5 years from enrollment, or planned receipt through study participation. Previous vaccination with any licensed or investigational RSV vaccine Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions and ending 30 days after the last study intervention administration, or their 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 the first study intervention administration and ending 30 days after the last study intervention administration. In the case of COVID 19 and inactivated/subunit influenza vaccines, this time window can be decreased to 14 days before and after each study intervention administration. In case of COVID-19 vaccine administration within 14 to 30 days window, the administration of COVID-19 vaccine should be in accordance with local government recommendations. Planned or actual administration of adjuvanted quadrivalent influenza vaccine or live influenza vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration. Note: In case an emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) 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 or designee is notified accordingly. 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 administration of first dose of study interventions 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 study intervention 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. 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). 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 conduct that prohibits participation until EoS. Participation of any study personnel or their immediate dependents, family, or household members.

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Co-ad Group

Control Group

Arm Description

Participants receive both the RSVPreF3 OA investigational vaccine and the PCV20 vaccine on Day 1.

Participants receive the PCV20 vaccine on Day 1 and the RSVPreF3 OA investigational vaccine on Day 31.

Outcomes

Primary Outcome Measures

Opsonophagocytic (OP) antibody (Ab) titers for each of the pneumococcal vaccine serotype (ST)
OP Ab titers are expressed as groups geometric mean titers (GMTs).
RSV-A neutralizing Ab titers
Ab titers are expressed as GMTs.
RSV-B neutralizing Ab titers
Ab titers are expressed as GMTs.

Secondary Outcome Measures

RSV-A neutralizing Ab titers expressed as mean geometric increase (MGI) over baseline at 1 month after the RSVPreF3 OA investigational vaccine dose
RSV-B neutralizing Ab titers expressed as MGI over baseline at 1 month after the RSVPreF3 OA investigational vaccine dose
Percentage of participants reporting each solicited administration site adverse event (AE)
The solicited administration site events after vaccination include pain, erythema/redness and swelling.
Percentage of participants reporting each solicited systemic AE
The solicited systemic events after vaccination include fever, headache, fatigue, myalgia and arthralgia.
Percentage of participants reporting unsolicited AE
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Percentage of participants reporting serious adverse events (SAEs) after vaccine administration
Percentage of participants reporting potential immune mediated diseased (pIMDs)
Potential immune-mediated disease is a subset of adverse events of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Full Information

First Posted
May 18, 2023
Last Updated
October 20, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT05879107
Brief Title
Study to Assess the Immune Response, the Safety and the Reactogenicity of Respiratory Syncytial Virus (RSV) Prefusion Protein 3 Older Adult (OA) (RSVPreF3 OA) Investigational Vaccine When co Administered With PCV20 in Older Adults
Official Title
A Phase III, Open-label, Randomized, Controlled, Multi-Country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co Administered With PCV20 in Adults Aged 60\xa0Years and Older
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 26, 2023 (Actual)
Primary Completion Date
December 11, 2023 (Anticipated)
Study Completion Date
May 28, 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with PCV20 and its safety in older adults, aged ≥60 years of age.

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, Vaccine, Older adult, Immunogenicity, Safety

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Co-ad Group
Arm Type
Experimental
Arm Description
Participants receive both the RSVPreF3 OA investigational vaccine and the PCV20 vaccine on Day 1.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants receive the PCV20 vaccine on Day 1 and the RSVPreF3 OA investigational vaccine on Day 31.
Intervention Type
Biological
Intervention Name(s)
RSVPreF3 OA investigational vaccine
Other Intervention Name(s)
RSVPreF3 OA
Intervention Description
One dose of RSVPreF3 OA vaccine given intramuscularly in participant's non-dominant arm on Day 1 (in the Coad group) or Day 31(in the Control group).
Intervention Type
Biological
Intervention Name(s)
PCV20
Other Intervention Name(s)
20 valent pneumococcal vaccine, Prevnar 20 (in US), Apexxnar (in Europe)
Intervention Description
One dose of the 20-valent pneumococcal conjugate vaccine (PCV20) given intramuscularly in participant's dominant arm (Coad group) or non-dominant arm (Control group) on Day 1
Primary Outcome Measure Information:
Title
Opsonophagocytic (OP) antibody (Ab) titers for each of the pneumococcal vaccine serotype (ST)
Description
OP Ab titers are expressed as groups geometric mean titers (GMTs).
Time Frame
1 month after the PCV20 dose (at Day 31)
Title
RSV-A neutralizing Ab titers
Description
Ab titers are expressed as GMTs.
Time Frame
1 month after the RSVPreF3 OA investigational vaccine dose (at Day 31 for the Co-ad group and at Day 61 for the Control group)
Title
RSV-B neutralizing Ab titers
Description
Ab titers are expressed as GMTs.
Time Frame
1 month after the RSVPreF3 OA investigational vaccine dose (at Day 31 for the Co-ad group and at Day 61 for the Control group)
Secondary Outcome Measure Information:
Title
RSV-A neutralizing Ab titers expressed as mean geometric increase (MGI) over baseline at 1 month after the RSVPreF3 OA investigational vaccine dose
Time Frame
From Baseline (Day 1) to 1 month after the RSVPreF3 OA investigational vaccine dose (at Day 31 for the Co-ad group and at Day 61 for the Control group)
Title
RSV-B neutralizing Ab titers expressed as MGI over baseline at 1 month after the RSVPreF3 OA investigational vaccine dose
Time Frame
From Baseline (Day 1) to 1 month after the RSVPreF3 OA investigational vaccine dose (at Day 31 for the Co-ad group and at Day 61 for the Control group)
Title
Percentage of participants reporting each solicited administration site adverse event (AE)
Description
The solicited administration site events after vaccination include pain, erythema/redness and swelling.
Time Frame
Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine (administered on Day 1 and Day 31)
Title
Percentage of participants reporting each solicited systemic AE
Description
The solicited systemic events after vaccination include fever, headache, fatigue, myalgia and arthralgia.
Time Frame
Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine (administered on Day 1 and Day 31)
Title
Percentage of participants reporting unsolicited AE
Description
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Time Frame
Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine (administered on Day 1 and Day 31)
Title
Percentage of participants reporting serious adverse events (SAEs) after vaccine administration
Time Frame
From vaccine administration (Day 1) up to end of study (6 months after last vaccination: Month 6 for the Co-ad group and Month 7 for the Control group)
Title
Percentage of participants reporting potential immune mediated diseased (pIMDs)
Description
Potential immune-mediated disease is a subset of adverse events of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time Frame
From vaccine administration (Day 1) up to end of study (6 months after last vaccination: Month 6 for the Co-ad group and Month 7 for the Control group)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A male or female ≥60 years of age at the time of the first study intervention administration. 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 any study-specific procedure being performed. 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. Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, are allowed to participate in this study if considered by the investigator as medically stable. Exclusion Criteria: 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 the study interventions, in particular any history of severe allergic reaction to any vaccine containing diphtheria toxoid, or pneumococcal polysaccharide 23-valent vaccine (PPSV23). Participants considered by investigator as suffering from serious or 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. 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. History of previous vaccination with any licensed or investigational pneumococcal conjugate vaccine, or planned receipt through study participation. History of previous vaccination with any licensed or investigational pneumococcal polysaccharide vaccine in the last 5 years from enrollment, or planned receipt through study participation. Previous vaccination with any licensed or investigational RSV vaccine Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions and ending 30 days after the last study intervention administration, or their 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 the first study intervention administration and ending 30 days after the last study intervention administration. In the case of COVID 19 and inactivated/subunit influenza vaccines, this time window can be decreased to 14 days before and after each study intervention administration. In case of COVID-19 vaccine administration within 14 to 30 days window, the administration of COVID-19 vaccine should be in accordance with local government recommendations. Planned or actual administration of adjuvanted quadrivalent influenza vaccine or live influenza vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration. Note: In case an emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) 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 or designee is notified accordingly. 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 administration of first dose of study interventions 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 study intervention 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. 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). 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 conduct that prohibits participation until EoS. Participation of any study personnel or their immediate dependents, family, or household members.
Facility Information:
Facility Name
GSK Investigational Site
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976
Country
United States
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
GSK Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
GSK Investigational Site
City
Modesto
State/Province
California
ZIP/Postal Code
95350
Country
United States
Facility Name
GSK Investigational Site
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06517
Country
United States
Facility Name
GSK Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
GSK Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
GSK Investigational Site
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
GSK Investigational Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
GSK Investigational Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
GSK Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
GSK Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
GSK Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
GSK Investigational Site
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
GSK Investigational Site
City
Frisco
State/Province
Texas
ZIP/Postal Code
75033
Country
United States
Facility Name
GSK Investigational Site
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
GSK Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
GSK Investigational Site
City
Antwerpen
ZIP/Postal Code
2000
Country
Belgium
Facility Name
GSK Investigational Site
City
Erpent (Namur)
ZIP/Postal Code
5101
Country
Belgium
Facility Name
GSK Investigational Site
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Kluisbergen
ZIP/Postal Code
9690
Country
Belgium
Facility Name
GSK Investigational Site
City
Massemen-Wetteren
ZIP/Postal Code
9230
Country
Belgium
Facility Name
GSK Investigational Site
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
GSK Investigational Site
City
Lodz
ZIP/Postal Code
91-363
Country
Poland
Facility Name
GSK Investigational Site
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
GSK Investigational Site
City
Pulawy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
GSK Investigational Site
City
Staszow
ZIP/Postal Code
28-200
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
00-215
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
02-793
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD Sharing Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD Sharing Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
IPD Sharing URL
https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Learn more about this trial

Study to Assess the Immune Response, the Safety and the Reactogenicity of Respiratory Syncytial Virus (RSV) Prefusion Protein 3 Older Adult (OA) (RSVPreF3 OA) Investigational Vaccine When co Administered With PCV20 in Older Adults

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