Respiratory Syncytial Virus InfectionsPhase 3NCT05879107

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 3 study testing RSVPreF3 OA investigational vaccine and PCV20 in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 38 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Virus Infections
What is being tested?: RSVPreF3 OA investigational vaccine and PCV20
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,113 participants
Where: 38 sitesin 4 countries
Study dates: 26 May 2023to 7 May 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 22Show fewer

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.

Trial locations and contacts

38 sites in 4 countries.

Country

City, postcode or hospital

38 sites in 4 countries

United States20 sites

GSK Investigational Site
Cincinnati, Ohio, 45212
GSK Investigational Site
Clearwater, Florida, 33756
GSK Investigational Site
Dallas, Texas, 75251
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Frisco, Texas, 75033
GSK Investigational Site
Guntersville, Alabama, 35976
GSK Investigational Site
Hamden, Connecticut, 06517
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Jupiter, Florida, 33458
GSK Investigational Site
Largo, Florida, 33777
GSK Investigational Site
Mesquite, Texas, 75149
GSK Investigational Site
Modesto, California, 95350
GSK Investigational Site
New Orleans, Louisiana, 70115
GSK Investigational Site
North Charleston, South Carolina, 29405
GSK Investigational Site
Orlando, Florida, 32801
GSK Investigational Site
Phoenix, Arizona, 85023
GSK Investigational Site
Plano, Texas, 75024
GSK Investigational Site
St Louis, Missouri, 63110
GSK Investigational Site
Troy, Michigan, 48085
GSK Investigational Site
West Des Moines, Iowa, 50266

Other trials in United States

Poland9 sites

GSK Investigational Site
Krakow, 31-501
GSK Investigational Site
Lodz, 91-363
GSK Investigational Site
Lublin, 20-362
GSK Investigational Site
Pu?awy, 24-100
GSK Investigational Site
Staszów, 28-200
GSK Investigational Site
Warsaw, 00-215
GSK Investigational Site
Warsaw, 02-677
GSK Investigational Site
Warsaw, 03-291
GSK Investigational Site
Wroclaw, 53-673

Other trials in Poland

Belgium6 sites

GSK Investigational Site
Antwerp, 2000
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Kluisbergen, 9690
GSK Investigational Site
Mechelen, 2800
GSK Investigational Site
Namur, 5000
GSK Investigational Site
Wetteren, 9230

Other trials in Belgium

Spain3 sites

GSK Investigational Site
Barcelona, 08023
GSK Investigational Site
Barcelona, 8025
GSK Investigational Site
Valencia, 46020

Other trials in Spain

About this study

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

Conditions: Respiratory Syncytial Virus Infections
Being tested: RSVPreF3 OA investigational vaccine, PCV20
Keywords: Respiratory syncytial virus, Vaccine, Older adult, Immunogenicity, Safety
Medical subject headings: Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RSVPreF3 OA investigational vaccineBiological
Also called RSVPreF3 OA
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).
PCV20Biological
Also called 20 valent pneumococcal vaccine, Prevnar 20 (in US), Apexxnar (in Europe)
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

Study groups in NCT05879107
Study group	Role	What they receive
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. Receives: 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. Receives: Biological: RSVPreF3 OA investigational vaccine; Biological: PCV20

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
The MGI was defined as the geometric mean increase of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay.
Measured: 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
The MGI was defined as the geometric mean increase of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay.
Measured: 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
The solicited administration site events after vaccination include pain, erythema/redness, and swelling.
Measured: 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
The solicited systemic events after vaccination include fever (pyrexia), headache, fatigue, myalgia and arthralgia. Fever is defined as body temperature >=38 degree Celsius; preferred location for measuring the temperature is oral.
Measured: 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
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the administration of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE is an AE that is 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. Unsolicited AEs are communicated by participant/participant's caregiver(s) who have signed the informed consent. Unsolicited AEs include both serious adverse events (SAEs) and non-serious AEs.
Measured: 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
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Measured: 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)
The pIMD is 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.
Measured: 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])

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 May 20237 May 2024

First posted30 May 2023
Study start26 May 2023
Primary completion6 Dec 2023
Study completion7 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05879107
Sponsor's protocol ID: 219276
Other IDs: 2022-501988-40-00
Status last verified: May 2025
First submitted: 18 May 2023
Last updated: 18 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer tohttps://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.

Publications

Leroux-Roels I, Lins M, Surowitz R, Pragalos A, Jua PKTG, Wauters D, Jayadev A, Akite JE, Jastorff AM, Cardenas V, Van der Wielen M; RSV-019 study group. Immunogenicity and Safety of Co-administration of Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine With 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged >/=60 Years: A Randomized, Non-inferiority Trial. Clin Infect Dis. 2026 Oct 7;83(3):e589-e597. doi: 10.1093/cid/ciag250.
PubMed 41994955

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization

All Respiratory Syncytial Virus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05879107
Acronym / sponsor ID: 219276
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory syncytial virus, Vaccine, Older adult, Immunogenicity, Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,113 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 26 May 2023 (actual)
Primary completion: 6 Dec 2023 (actual)
Study completion: 7 May 2024 (actual)
First posted: 30 May 2023 (actual)
Results: Posted 18 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Co-administration Group	Experimental	Biological: RSVPreF3 OA investigational vaccine, Biological: PCV20Participants received both respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine and 20-valent pneumococcal conjugate vaccine (PCV20) on Day 1.
Control Group	Active comparator	Biological: RSVPreF3 OA investigational vaccine, Biological: PCV20Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (22 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RSVPreF3 OA investigational vaccineAlso: RSVPreF3 OAOne 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).	Biological	Co-administration Group, Control Group
PCV20Also: 20 valent pneumococcal vaccine, Prevnar 20 (in US), Apexxnar (in Europe)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	Biological	Co-administration Group, Control Group

Primary outcome

Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Time frame: At Day 31
The OP titers were measured with multiplexed opsonophagocytosis assay and the results were expressed as GMT for each of the pneumococcal vaccine serotype.
Adjusted GMTs of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination
Time frame: At Day 31 for Co-administration Group and at Day 61 for Control Group
Neutralizing titers were measured with neutralization assay and the results were expressed in ED60.
Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination
Time frame: At Day 31 for Co-administration Group and at Day 61 for Control Group
Neutralizing titers were measured with neutralization assay and the results were expressed in ED60.

7 secondary outcomes

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

Results and safety

Results posted to the registry on 18 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Co-administration Group	553	539
Control Group	557	531

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

Time frame: At Day 31. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Co-administration Group n = 514	Control Group n = 497
Strep pneumoniae - serotype 1	74.7 (64.1 to 87.1)	110.8 (94.8 to 129.5)
Strep pneumoniae - serotype 3	88.5 (78.3 to 99.9)	116.2 (102.7 to 131.5)
Strep pneumoniae - serotype 4	1220.9 (1072.9 to 1389.3)	1634.1 (1433.4 to 1862.8)
Strep pneumoniae - serotype 5	191.0 (159.9 to 228.1)	260.3 (217.3 to 311.8)
Strep pneumoniae - serotype 6A	1790.0 (1527.8 to 2097.2)	2458.3 (2091.8 to 2889.1)
Strep pneumoniae - serotype 6B	2121.6 (1839.0 to 2447.6)	2996.9 (2590.3 to 3467.2)
Strep pneumoniae - serotype 7F	2411.3 (2154.1 to 2699.2)	3225.1 (2876.2 to 3616.4)
Strep pneumoniae - serotype 8	522.9 (458.5 to 596.4)	723.0 (632.5 to 826.5)

Co-administration Group vs Control Group: GMT ratio: 1.48 (95% CI 1.22 to 1.81)
Co-administration Group vs Control Group: GMT ratio: 1.31 (95% CI 1.12 to 1.54)
Co-administration Group vs Control Group: GMT ratio: 1.34 (95% CI 1.13 to 1.58)

Population analysed: Per protocol set (PPS) for PCV20 included all eligible participants in the exposed set who: received the PVC20 vaccine, had immunogenicity results for OP titers, complied with blood draw interval, without intercurrent medical conditions and without prohibited concomitant medication/vaccination and who did not meet any of the criteria for elimination up to blood sample collection. Only participants with data available at the specified timepoint were included in the analysis.

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

Time frame: At Day 31 for Co-administration Group and at Day 61 for Control Group. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Co-administration Group n = 512	Control Group n = 382
Value	8338.2 (7639.0 to 9101.4)	8872.7 (8038.2 to 9793.9)

Co-administration Group vs Control Group: GMT ratio: 1.06 (95% CI 0.94 to 1.20)

Population analysed: PPS for RSVPreF3 OA included all eligible participants in the exposed set who: received the RSVPreF3 OA vaccine, had immunogenicity results for RSV neutralizing titers, complied with blood draw interval, without intercurrent medical conditions and without prohibited concomitant medication/vaccination and who did not meet any of the criteria for elimination up to blood sample collection. Only the participants with RSV-A data at the specified timepoints were included in the analysis.

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

Time frame: At Day 31 for Co-administration Group and at Day 61 for Control Group. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Co-administration Group n = 511	Control Group n = 382
Value	9477.5 (8695.4 to 10329.9)	9497.6 (8620.5 to 10463.9)

Co-administration Group vs Control Group: GMT ratio: 1.00 (95% CI 0.89 to 1.13)

Population analysed: PPS for RSVPreF3 OA. Only the participants with RSV-B data at the specified timepoints were included in the analysis.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Co-administration Group	9 of 553 (1.6%)	410 of 553 (74.1%)	0 of 553
Control Group	14 of 557 (2.5%)	423 of 557 (75.9%)	2 of 557

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41994955Leroux-Roels I, Lins M, Surowitz R, Pragalos A, Jua PKTG, Wauters D, Jayadev A, Akite JE, Jastorff AM, Cardenas V, Van der Wielen M; RSV-019 study group. Immunogenicity and Safety of Co-administration of Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine With 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged >/=60 Years: A Randomized, Non-inferiority Trial. Clin Infect Dis. 2026 Oct 7;83(3):e589-e597. doi: 10.1093/cid/ciag250.
Individual participant dataSharing planned: Yes. GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer tohttps://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.

Related trials for Respiratory Syncytial Virus Infections

RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

38 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVPreF3 OA investigational vaccine and PCV20 in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 38 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Poland, Belgium, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination (time frame: At Day 31). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05879107, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.