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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Biological: RSVPreF3 OA investigational vaccine; Biological: PCV20

• Study Type: Interventional
• Enrollment (Actual): 1113
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
• Study Contact Backup: Name: EU GSK Clinical Trials Call Center; Phone Number: +44 (0) 20 89904466; Email: GSKClinicalSupportHD@gsk.com

Study Locations

• Belgium
  • Antwerpen, Belgium, 2000
    • GSK Investigational Site
  • Erpent (Namur), Belgium, 5101
    • GSK Investigational Site
  • Ghent, Belgium, 9000
    • GSK Investigational Site
  • Kluisbergen, Belgium, 9690
    • GSK Investigational Site
  • Massemen-Wetteren, Belgium, 9230
    • GSK Investigational Site
  • Mechelen, Belgium, 2800
    • GSK Investigational Site
• Poland
  • Krakow, Poland, 31-501
    • GSK Investigational Site
  • Lodz, Poland, 91-363
    • GSK Investigational Site
  • Lublin, Poland, 20-362
    • GSK Investigational Site
  • Pulawy, Poland, 24-100
    • GSK Investigational Site
  • Staszow, Poland, 28-200
    • GSK Investigational Site
  • Warszawa, Poland, 02-793
    • GSK Investigational Site
  • Warszawa, Poland, 03-291
    • GSK Investigational Site
  • Warszawa, Poland, 00-215
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08025
    • GSK Investigational Site
  • Barcelona, Spain, 08023
    • GSK Investigational Site
  • Valencia, Spain, 46015
    • GSK Investigational Site
• United States
  • Alabama
    • Guntersville, Alabama, United States, 35976
      • GSK Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • GSK Investigational Site
  • California
    • Huntington Beach, California, United States, 92647
      • GSK Investigational Site
    • Modesto, California, United States, 95350
      • GSK Investigational Site
  • Connecticut
    • Hamden, Connecticut, United States, 06517
      • GSK Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33756
      • GSK Investigational Site
    • DeLand, Florida, United States, 32720
      • GSK Investigational Site
    • Jupiter, Florida, United States, 33458
      • GSK Investigational Site
    • Largo, Florida, United States, 33777
      • GSK Investigational Site
    • Orlando, Florida, United States, 32801
      • GSK Investigational Site
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • GSK Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • GSK Investigational Site
  • Michigan
    • Troy, Michigan, United States, 48085
      • GSK Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • GSK Investigational Site
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • GSK Investigational Site
  • Texas
    • Dallas, Texas, United States, 75251
      • GSK Investigational Site
    • Frisco, Texas, United States, 75033
      • GSK Investigational Site
    • Mesquite, Texas, United States, 75149
      • GSK Investigational Site
    • Plano, Texas, United States, 75024
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Co-ad Group; Participants receive both the RSVPreF3 OA investigational vaccine and the PCV20 vaccine on Day 1.	Biological: RSVPreF3 OA investigational vaccine; 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).; Other Names: RSVPreF3 OA; Biological: PCV20; 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; Other Names: 20 valent pneumococcal vaccine, Prevnar 20 (in US), Apexxnar (in Europe)
Active Comparator: Control Group; Participants receive the PCV20 vaccine on Day 1 and the RSVPreF3 OA investigational vaccine on Day 31.	Biological: RSVPreF3 OA investigational vaccine; 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).; Other Names: RSVPreF3 OA; Biological: PCV20; 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; Other Names: 20 valent pneumococcal vaccine, Prevnar 20 (in US), Apexxnar (in Europe)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opsonophagocytic (OP) antibody (Ab) titers for each of the pneumococcal vaccine serotype (ST)	OP Ab titers are expressed as groups geometric mean titers (GMTs).	1 month after the PCV20 dose (at Day 31)
RSV-A neutralizing Ab titers	Ab titers are expressed as GMTs.	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)
RSV-B neutralizing Ab titers	Ab titers are expressed as GMTs.	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 Measures

Outcome Measure	Measure Description	Time Frame
RSV-A neutralizing Ab titers expressed as mean geometric increase (MGI) over baseline at 1 month after the RSVPreF3 OA investigational vaccine dose		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)
RSV-B neutralizing Ab titers expressed as MGI over baseline at 1 month after the RSVPreF3 OA investigational vaccine dose		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)
Percentage of participants reporting each solicited administration site adverse event (AE)	The solicited administration site events after vaccination include pain, erythema/redness and swelling.	Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine (administered on Day 1 and Day 31)
Percentage of participants reporting each solicited systemic AE	The solicited systemic events after vaccination include fever, headache, fatigue, myalgia and arthralgia.	Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine (administered on Day 1 and Day 31)
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.	Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine (administered on Day 1 and Day 31)
Percentage of participants reporting serious adverse events (SAEs) after vaccine administration		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)
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.	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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2023
• Primary Completion (Estimated): December 11, 2023
• Study Completion (Estimated): May 28, 2024

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Vaccine; Immunogenicity; Respiratory syncytial virus; Older adult
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 219276; 2022-501988-40-00 (Other Identifier: EU CTR number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No