A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

March 5, 2026 updated by: GlaxoSmithKline

A Phase 2b, Non-randomized, Controlled, Open-label, Extension Study to Evaluate the Persistence of Immune Response of the Adjuvanted RSVPreF3 Vaccine and the Safety and Immunogenicity Following Revaccination in Lung and Kidney Transplant Recipients (>=18 Years of Age)

This study evaluates persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Lung or kidney transplant recipients undergoing chronic immunosuppressive therapy, who received 1 (IC_1 group) and 2 (IC_2 group) doses of the adjuvanted RSVPreF3 vaccine in the RSV OA=ADJ-023 study [parent study; NCT05921903], will receive an additional dose of the adjuvanted RSVPreF3 vaccine in the current study. As pre-assigned in protocol, the participants that received 1 dose and 2 doses of adjuvanted RSVPreF3 vaccine in the parent study will be analysed separately in the current study for the immune response analyses, and under an overall group (IC Revaccination group) for the demographic and safety analyses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Steve Chadban
    • Queensland
      • Birtinya, Queensland, Australia, 4556
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Nicholas Gray
        • Contact:
        • Contact:
      • Herston, Queensland, Australia, 4029
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Nissen
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karen Doucette
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Celine Bergeron
        • Contact:
        • Contact:
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sarah Shalhoub
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M5G 2N2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Deepali Kumar
  • Germany
      • Giessen, Germany, 35392
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hristos Karakizlis
  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rossana Caldara
      • Milan, Italy, 20122
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Letizia Corinna Morlacchi
      • Pavia, Italy, 27100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valentina Vertui
      • Siena, Italy, 53100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Bennett
  • Japan
      • Aichi, Japan, 470-1192
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takashi Kenmochi
      • Aichi, Japan, 466-8650
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kenta Futamura
      • Fukuoka, Japan, 814-0180
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • So Miyahara
      • Hyōgo, Japan, 662-0918
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hidefumi Kishikawa
      • Kumamoto, Japan, 861-8520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shigeyoshi Yamanaga
      • Okayama, Japan, 700-8558
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seiichiro Sugimoto
      • Tokyo, Japan, 193-0998
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hitoshi Iwamoto
  • South Korea
      • Seoul, South Korea, 03722
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Su Jin Jeong
      • Seoul, South Korea, 110-774
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pyoeng Gyun Choe
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • maria jose PEREIRA RODRIGUEZ
      • Barcelona, Spain, 8907
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Cristina Masuet Aumatell
        • Contact:
        • Contact:
      • Barcelona, Spain, 8036
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Fritz Diekmann
        • Contact:
        • Contact:
      • Córdoba, Spain, 14004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Luisa Aguera Morales
      • Madrid, Spain, 28034
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sara Jimenez
      • Madrid, Spain, 28040
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Sanchez Fructuoso
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pablo Rojo
      • Madrid, Spain, 28007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • María Luisa Rodríguez Ferrero
      • Santander, Spain, 39011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Henar Rebollo
  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Richard Greenberg
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tarek Alhamad
        • Contact:
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anum Abbas
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Catherine Small
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fernanda Silveira
    • Texas
      • Temple, Texas, United States, 76502
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohanram Narayanan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants of the RSV OA=ADJ-023 study from the Per Protocol Set (Visit 3 for participants in IC_1 and Visit 4 for participants in IC_2 group), who received either 1 or 2 doses of the adjuvanted RSVPreF3 vaccine and for whom the immunogenicity data are available.
  • Participants who, can and will comply with the requirements of the protocol (e.g., completion of the paper diary cards (as applicable), return for follow-up visits, ability to access and utilize a phone or other electronic communications, have regular contact to allow evaluation during the study).
  • Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
  • Female participants of nonchildbearing potential may be enrolled in the study. Non childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause.
  • Female participants of childbearing potential may be enrolled in the study if the participant:
  • has practiced adequate contraception from 1 month prior to study intervention administration, and
  • agreed to continue adequate contraception until 1 month after study intervention, and
  • has a negative pregnancy test on the day of and prior to study intervention administration.
  • Participant who has received an ABO compatible allogeneic kidney or lung transplant (allograft) more than 12 months (365 days) prior to the study intervention administration.
  • Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection.

Specific inclusion criteria for kidney transplant (KTx) patients

• Participant with stable kidney function, stability defined as less than 20% variability between last two results of eGFR or in the opinion of the investigator after investigator review of more than the last two results of eGFRs and based on medical history.

Specific inclusion criteria for lung transplant (LTx) patients • Participant with stable lung function, with stability defined as the stability in the FEV1 compared to post-transplant baseline FEV1 and based on medical history of the last 3 months, in the opinion of the investigator.

Exclusion Criteria:

Medical conditions

  • Any history of dementia or any medical condition that moderately or severely impairs cognition.
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival up to study end).
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention
  • Acute or chronic clinically significant cardiovascular or hepatic functional abnormality, as determined by physical examination or laboratory screening tests.
  • Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled 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.
  • Any condition which, in the judgment of the investigator, would make IM injection unsafe.
  • Any other clinical condition that might pose additional risk to the participant due to participation in the clinical study.

Prior/Concomitant therapy

  • Vaccination with RSV-antigen containing vaccine after 1 or 2 doses received in the RSV OA=ADJ-023 study.
  • Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention administration during the period beginning 30 days before the study intervention administration (Day -30 to Day 1), or their planned use during the study period (up to Month 12).

  • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the study intervention administration and ending 30 days after the study intervention administration*. In the case of COVID-19 and inactivated/subunit/split influenza vaccines, this time window can be decreased to 14 days before and after study intervention administration.

    • If 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 of 30 days described above can be reduced, if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified.

Prior/Concurrent clinical study experience

• 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 intervention (drug/invasive medical device).

Other exclusion criteria

  • 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.
  • Any study personnel or their immediate dependents, family, or household members.
  • Planned move during the study period that will prohibit participating in the study until study end.
  • Pregnant or lactating female participant.
  • Female participant planning to become pregnant or planning to discontinue contraceptive precautions.
  • More than one organ transplanted (i.e., kidney-liver or kidney-other organ(s) transplanted). Dual organ is allowed (double kidney or double lung).
  • History of events that, in the opinion of the investigator, may put the participant at increased risk for chronic allograft dysfunction.
  • Participant with an episode of allograft rejection within 3 months (90 days) prior to Visit 1.
  • Histologic evidence of chronic allograft injury.
  • Active treatment for acute rejection.
  • Current diagnosis of malignancy (except non-melanoma skin cancer that does not require systemic therapy).
  • Any autoimmune conditions or pIMDs that in the opinion of the investigator may put the participant at increased risk.
  • Any confirmed or suspected HIV infection or primary immunodeficiency disease or ongoing CMV infection with a viremia > 200 IU/mL.
  • Use of anti-CD20 or other B-cell monoclonal antibody agents (e.g., rituximab) as induction, maintenance and/or therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months (274 days) prior to Visit 1.
  • Use of investigational and non-registered immunosuppressants at the local/country level, unless specifically prescribed for the prevention of allograft rejection, and which are non-registered and:
  • available locally through compassionate use programs,
  • submitted for and pending local/country registration,
  • approved and registered for use in other countries with well-documented SmPC or Prescribing Information. The name of the active component(s) of these immunosuppressants must be provided in the concomitant medication listing.
  • Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of induction and/or maintenance immunosuppressive therapies.
  • Any clinically significant (based on the Investigator's clinical judgement) hematologic (hemoglobin level, white blood cell, lymphocyte, neutrophil, eosinophil, platelet red blood cell count and erythrocyte mean corpuscular volume) and/or biochemical (ALT, AST, creatinine, blood urea nitrogen) laboratory abnormality.

Specific exclusion criteria for KTx patients:

  • Previous allograft loss secondary to recurrent primary kidney disease. Multiple consecutive kidney transplants are allowed if the reason for a previous allograft loss is not recurrent primary kidney disease.
  • Evidence of significant proteinuria/albuminuria in the opinion of the investigator.

Specific exclusion criteria for LTx patients:

  • At study intervention administration visit, diagnosis of documented acute pulmonary infection within the 2 prior weeks, based on the following: clinical, radiological, and/or physiological deterioration; OR isolation of an organism from a clinically relevant BAL fluid culture.
  • Patients with diagnosis of chronic lung allograft dysfunction, defined as a decrement of 20% or more in FEV1 compared to post-transplant baseline FEV1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IC Revaccination Group
Lung or kidney transplant recipients undergoing chronic immunosuppressive therapy who received 1 and 2 doses of the adjuvanted RSVPreF3 vaccine (IC_1 and IC_2 groups respectively) in the RSV OA=ADJ-023 parent study will receive a revaccination dose of adjuvanted RSVPreF3 vaccine at Visit 1 (Day 1) in the current study.
Biological: Adjuvanted RSVPreF3 vaccine
1 dose of adjuvanted RSVPreF3 vaccine administered intramuscularly at Visit 1 (Day 1).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
RSV-A neutralizing titers expressed as Geometric mean titers (GMTs)
Time Frame: At Visit 1 (Day 1) of the current study
RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60). GMT is calculated by taking the anti-log of the mean of the log titer transformations.
At Visit 1 (Day 1) of the current study
RSV-B neutralizing titers expressed as GMTs
Time Frame: At Visit 1 (Day 1) of the current study
RSV-B neutralizing titers are given as group GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
At Visit 1 (Day 1) of the current study
RSV-A neutralizing titers expressed as Mean geometric increase (MGI)
Time Frame: At Visit 1 (Day 1) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study
MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 1 over titers observed 30 days post last dose in the RSV OA=ADJ-023 parent study).
At Visit 1 (Day 1) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study
RSV-B neutralizing titers expressed as MGI
Time Frame: At Visit 1 (Day 1) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study
MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 1 over titers observed 30 days post last dose in the RSV OA=ADJ-023 parent study).
At Visit 1 (Day 1) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study
RSV-A neutralizing titers expressed as GMTs
Time Frame: At Visit 2 (Day 31) of the current study
RSV-A neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
At Visit 2 (Day 31) of the current study
RSV-B neutralizing titers expressed as GMTs
Time Frame: At Visit 2 (Day 31) of the current study
RSV-B neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
At Visit 2 (Day 31) of the current study
RSV-A neutralizing titers expressed as GMTs
Time Frame: At Visit 3 (Day 180) of the current study
RSV-A neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
At Visit 3 (Day 180) of the current study
RSV-B neutralizing titers expressed as GMTs
Time Frame: At Visit 3 (Day 180) of the current study
RSV-B neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
At Visit 3 (Day 180) of the current study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
GMT ratio of RSV-A neutralizing titers
Time Frame: At Visit 1 (Day 1) of the current study
RSV-A neutralizing titers are given as group GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
At Visit 1 (Day 1) of the current study
GMT ratio of RSV-B neutralizing titers
Time Frame: At Visit 1 (Day 1) of the current study
RSV-B neutralizing titers are given as group GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
At Visit 1 (Day 1) of the current study
RSV-A neutralizing titers expressed as MGI
Time Frame: At Visit 2 (Day 31) over Visit 1 (Day 1) and at Visit 3 (Day 180) over Visit 1 (Day 1) [each visit of the current study]
MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 2 over titers observed at Visit 1, and Visit 3 over Visit 1).
At Visit 2 (Day 31) over Visit 1 (Day 1) and at Visit 3 (Day 180) over Visit 1 (Day 1) [each visit of the current study]
RSV-B neutralizing titers expressed as MGI
Time Frame: At Visit 2 (Day 31) over Visit 1 (Day 1) and at Visit 3 (Day 180) over Visit 1 (Day 1) [each visit of the current study]
MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 2 over titers observed at Visit 1, and Visit 3 over Visit 1).
At Visit 2 (Day 31) over Visit 1 (Day 1) and at Visit 3 (Day 180) over Visit 1 (Day 1) [each visit of the current study]
RSV-A neutralizing titers expressed as MGI
Time Frame: At Visit 2 (Day 31) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study
MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 2 over titers observed at 30 days post last dose in the RSV OA=ADJ-023 parent study).
At Visit 2 (Day 31) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study
RSV-B neutralizing titers expressed as MGI
Time Frame: At Visit 2 (Day 31) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study
MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 2 over titers observed at 30 days post last dose in the RSV OA=ADJ-023 parent study).
At Visit 2 (Day 31) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study
Number of participants reporting each solicited administration site event
Time Frame: Visit 1 (Day 1 [day of revaccination]) to Day 7 of the current study
Solicited administration site events assessed are pain, redness and swelling.
Visit 1 (Day 1 [day of revaccination]) to Day 7 of the current study
Number of participants reporting each solicited systemic event
Time Frame: Visit 1 (Day 1 [day of revaccination]) to Day 7 of the current study
Solicited systemic events assessed are fever, headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness).
Visit 1 (Day 1 [day of revaccination]) to Day 7 of the current study
Number of participants reporting unsolicited adverse events (AEs)
Time Frame: Visit 1 (Day 1 [day of revaccination]) to Day 30 of the current study
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. Unsolicited AEs include both serious and nonserious AEs.
Visit 1 (Day 1 [day of revaccination]) to Day 30 of the current study
Number of participants reporting any serious adverse events (SAEs)
Time Frame: Visit 1 (Day 1 [day of revaccination] to Visit 3 (Day 180) of the current study
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes. Any SAE = occurrence of the SAE regardless of relation to study vaccination.
Visit 1 (Day 1 [day of revaccination] to Visit 3 (Day 180) of the current study
Number of participants reporting related SAEs and fatal SAEs
Time Frame: Visit 1 (Day 1 [day of revaccination] to study end (Day 365) of the current study
Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.
Visit 1 (Day 1 [day of revaccination] to study end (Day 365) of the current study
Number of participants reporting any Potential immune-mediated disease (pIMDs) and related pIMDs
Time Frame: Visit 1 (Day 1 [day of revaccination] to study end (Day 365) of the current study
pIMDs are 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. Any pIMDs = occurrence of the pIMDs regardless of relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.
Visit 1 (Day 1 [day of revaccination] to study end (Day 365) of the current study
Number of participants reporting AESIs specific to kidney and lung SOT patients
Time Frame: Visit 1 (Day 1 [day of revaccination] to study end (Day 365) of the current study
AESIs specific to kidney and lung SOT patients include signs of transplant/allograft rejection.
Visit 1 (Day 1 [day of revaccination] to study end (Day 365) of the current study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 12, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 224083
  • 2024-519730-23-00 (Registry Identifier: EU CT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

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 asset(s) with development terminated 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Dietary Supplements

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