Last updated: 04/30/2026 11:50:10

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

GSK study ID
219276
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Adjusted geometric mean titers (GMT) of opsonophagocytic (OP) titers at 1 month after the PCV20 vaccination

Timeframe: 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

Timeframe: 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

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

Secondary outcomes:

Mean geometric increase (MGI) of RSV-A neutralizing titers at 1 month after the RSVPreF3 OA vaccination

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Number of participants with SAEs

Timeframe: Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-administration Group and Day 31 for Control Group])

Number of participants with potential immune-mediated diseases (pIMDs)

Timeframe: Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-administration Group and Day 31 for Control Group])

Interventions:
Biological/vaccine: RSVPreF3 OA investigational vaccine
Biological/vaccine: PCV20
Enrollment:
1112
Observational study model:
Not applicable
Primary completion date:
2023-06-12
Time perspective:
Not applicable
Clinical publications:
Garassino M, Cousin S, Besse B, Sacher A, Orlov S, Schenker M, et al. . ENTRÉE Lung Platform Trial Sub-study 1: Phase II Randomized Efficacy and Safety Analysis of Feladilimab Plus Docetaxel Versus Docetaxel Monotherapy in Advanced/Recurrent NSCLC. Clin lung Cancer. 2026; doi:10.1016/j.cllc.2026.04.003 https://www.clinical-lung-cancer.com/article/S1525-7304(26)00054-9/abstract PMID: 41994955 DOI: 10.1093/cid/ciag250
Medical condition
Respiratory Syncytial Virus Infections
Product
Not applicable
Collaborators
Not applicable
Study date(s)
May 2023 to May 2024
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
Yes
  • 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.
  • 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).

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Guntersville, AL, United States, 35976
Status
Study Complete
Location
GSK Investigational Site
Modesto, CA, United States, 95350
Status
Study Complete
Location
GSK Investigational Site
Phoenix, AZ, United States, 85023
Status
Study Complete
Location
GSK Investigational Site
Frisco, TX, United States, 75033
Status
Study Complete
Location
GSK Investigational Site
West Des Moines, IA, United States, 50266
Status
Study Complete
Location
GSK Investigational Site
Antwerpen, Belgium, 2000
Status
Study Complete
Location
GSK Investigational Site
Barcelona, Spain, 08023
Status
Study Complete
Location
GSK Investigational Site
Barcelona, Spain, 8025
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, OH, United States, 45212
Status
Study Complete
Location
GSK Investigational Site
Clearwater, FL, United States, 33756
Status
Study Complete
Location
GSK Investigational Site
Dallas, TX, United States, 75251
Status
Study Complete
Location
GSK Investigational Site
Gent, Belgium, 9000
Status
Study Complete
Location
GSK Investigational Site
Hamden, CT, United States, 06517
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, CA, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Jupiter, FL, United States, 33458
Status
Study Complete
Location
GSK Investigational Site
Kluisbergen, Belgium, 9690
Status
Study Complete
Location
GSK Investigational Site
KrakOw, Poland, 31-501
Status
Study Complete
Location
GSK Investigational Site
Lodz, Poland, 91-363
Status
Study Complete
Location
GSK Investigational Site
Staszow, Poland, 28-200
Status
Study Complete
Location
GSK Investigational Site
Lublin, Poland, 20-362
Status
Study Complete
Location
GSK Investigational Site
Mechelen, Belgium, 2800
Status
Study Complete
Location
GSK Investigational Site
Mesquite, TX, United States, 75149
Status
Study Complete
Location
GSK Investigational Site
Namur, Belgium, 5000
Status
Study Complete
Location
GSK Investigational Site
New Orleans, LA, United States, 70115
Status
Study Complete
Location
GSK Investigational Site
North Charleston, SC, United States, 29405
Status
Study Complete
Location
GSK Investigational Site
Deland, FL, United States, 32720
Status
Study Complete
Location
GSK Investigational Site
Orlando, FL, United States, 32801
Status
Study Complete
Location
GSK Investigational Site
Plano, TX, United States, 75024
Status
Study Complete
Location
GSK Investigational Site
Pu?awy, Poland, 24-100
Status
Study Complete
Location
GSK Investigational Site
St Louis, MO, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Largo, FL, United States, 33777
Status
Study Complete
Location
GSK Investigational Site
Troy, MI, United States, 48085
Status
Study Complete
Location
GSK Investigational Site
Valencia, Spain, 46020
Status
Study Complete
Location
GSK Investigational Site
Warsaw, Poland, 03-291
Status
Study Complete
Location
GSK Investigational Site
Warszawa, Poland, 00-215
Status
Study Complete
Location
GSK Investigational Site
Warszawa, Poland, 02-677
Status
Study Complete
Location
GSK Investigational Site
Wetteren, Belgium, 9230
Status
Study Complete
Location
GSK Investigational Site
Wroclaw, Poland, 53-673
Status
Study Complete
Location
GSK Investigational Site
Barcelona, Spain, 8540
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Genk, Belgium, 3600
Status
Terminated/Withdrawn
Location
GSK Investigational Site
MOstoles, Spain, 28938
Status
Terminated/Withdrawn

Study documents

Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2023-06-12
Actual study completion date
2024-07-05

Plain language summaries

Summary of results in plain language
Available language(s): English, Dutch (Belgium), French (Belgium), German (Belgium), Polish, Spanish, Spanish (United States)

To view plain language summaries on trialsummaries.com click here.

Additional information about the trial

Additional information
Not applicable
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