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

NCT05879107 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2192762022-501988-40-00
• Study Type: interventional
• Target: 1,113
• Locations: 4 countries
• Sites: 38

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.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory syncytial virus; Vaccine; Older adult; Immunogenicity; Safety

Outcome Measures

Primary Outcomes (3)

• Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination

  The OP titers were measured with multiplexed opsonophagocytosis assay and the results were expressed as GMT for each of the pneumococcal vaccine serotype.

  At Day 31

• Adjusted GMTs of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination

  Neutralizing titers were measured with neutralization assay and the results were expressed in ED60.

  At Day 31 for Co-administration Group and at Day 61 for Control Group

• Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination

  Neutralizing titers were measured with neutralization assay and the results were expressed in ED60.

  At Day 31 for Co-administration Group and at Day 61 for Control Group

Secondary Outcomes (7)

• Mean Geometric Increase (MGI) of RSV-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination

  At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Day 31 for Control Group)

• MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination

  At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Day 31 for Control Group)

• Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration

  Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)

• Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration

  Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)

• Number of Participants With Unsolicited AEs

  Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)

Study Arms (2)

Co-administration Group

EXPERIMENTAL

Participants received both respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine and 20-valent pneumococcal conjugate vaccine (PCV20) on Day 1.

Biological: RSVPreF3 OA investigational vaccine; Biological: PCV20

Control Group

ACTIVE COMPARATOR

Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.

Biological: RSVPreF3 OA investigational vaccine; Biological: PCV20

Interventions

RSVPreF3 OA investigational vaccine BIOLOGICAL

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).

Also known as: RSVPreF3 OA

Co-administration Group; Control Group

PCV20 BIOLOGICAL

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

Also known as: 20 valent pneumococcal vaccine, Prevnar 20 (in US), Apexxnar (in Europe)

Co-administration Group; Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (38)

GSK Investigational Site

Guntersville, Alabama, 35976, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85023, United States

Location

GSK Investigational Site

Huntington Beach, California, 92647, United States

Location

GSK Investigational Site

Modesto, California, 95350, United States

Location

GSK Investigational Site

Hamden, Connecticut, 06517, United States

Location

GSK Investigational Site

Clearwater, Florida, 33756, United States

Location

GSK Investigational Site

DeLand, Florida, 32720, United States

Location

GSK Investigational Site

Jupiter, Florida, 33458, United States

Location

GSK Investigational Site

Largo, Florida, 33777, United States

Location

GSK Investigational Site

Orlando, Florida, 32801, United States

Location

GSK Investigational Site

West Des Moines, Iowa, 50266, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70115, United States

Location

GSK Investigational Site

Troy, Michigan, 48085, United States

Location

GSK Investigational Site

St Louis, Missouri, 63110, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45212, United States

Location

GSK Investigational Site

North Charleston, South Carolina, 29405, United States

Location

GSK Investigational Site

Dallas, Texas, 75251, United States

Location

GSK Investigational Site

Frisco, Texas, 75033, United States

Location

GSK Investigational Site

Mesquite, Texas, 75149, United States

Location

GSK Investigational Site

Plano, Texas, 75024, United States

Location

GSK Investigational Site

Antwerp, 2000, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Kluisbergen, 9690, Belgium

Location

GSK Investigational Site

Mechelen, 2800, Belgium

Location

GSK Investigational Site

Namur, 5000, Belgium

Location

GSK Investigational Site

Wetteren, 9230, Belgium

Location

GSK Investigational Site

Krakow, 31-501, Poland

Location

GSK Investigational Site

Lodz, 91-363, Poland

Location

GSK Investigational Site

Lublin, 20-362, Poland

Location

GSK Investigational Site

Pu?awy, 24-100, Poland

Location

GSK Investigational Site

Staszów, 28-200, Poland

Location

GSK Investigational Site

Warsaw, 00-215, Poland

Location

GSK Investigational Site

Warsaw, 02-677, Poland

Location

GSK Investigational Site

Warsaw, 03-291, Poland

Location

GSK Investigational Site

Wroclaw, 53-673, Poland

Location

GSK Investigational Site

Barcelona, 08023, Spain

Location

GSK Investigational Site

Barcelona, 8025, Spain

Location

GSK Investigational Site

Valencia, 46020, Spain

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 30, 2023
• Study Start: May 26, 2023
• Primary Completion: December 6, 2023
• Study Completion: May 7, 2024
• Last Updated: May 18, 2025
• Results First Posted: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

BE (6); US (20); PL (9); ES (3)