AzTrials
AzTrials

Respiratory Syncytial Virus InfectionsPhase 2RSV OA=ADJ-023NCT05921903

A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above

A Phase 2 study testing RSVPreF3 OA Investigational Vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 46 sites in 8 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 evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
RSVPreF3 OA Investigational Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
386 participants
Where
46 sitesin 8 countries
Study dates
28 Jul 2023to 16 May 2025
Phase
Phase 2
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants and/or participant's parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.
  • Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) (participant must be able to understand the informed consent) 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 study end for this study, and has a negative pregnancy test on the day of and prior to study intervention administration.
  • Specific inclusion criteria for renal/lung transplant patients:
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  • A male or female, >=18 YoA at the time of signing the Informed consent form (ICF) or Informed assent form (IAF).
  • Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than legal age of consent, or written informed consent obtained from the participant if the participant has achieved legal age of consent.
  • Participant who has received an ABO compatible allogeneic renal or lung transplant (allograft) more than 12 months (365 days) prior to the first study intervention administration.
  • Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection.
  • Specific inclusion criteria for renal transplant (RTx) patients:
  • Participant with stable renal 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.
  • Specific inclusion criteria for healthy participants:
  • A male or female, >=50 YoA at the time of signing the ICF.
  • Healthy participants as established by medical history and clinical examination before entering the study.
  • 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, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.

Who cannot join

  • Medical conditions:
  • History of any reaction/ 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/uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study if their condition will allow them to comply with the requirements of the protocol, with the help of a caregiver if needed.
  • Any history of dementia or any medical condition that moderately or severely impairs cognition.
  • Any condition which would make IM injection unsafe.
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  • Significant underlying illness that would prevent completion of the study).
  • Acute disease and/or fever at the time of study intervention administration (>=38°C /100.4°F, oral or axillary). Participants with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Bedridden participants.
  • Prior/Concomitant therapy:
  • Use of any other investigational or non-registered product (drug, vaccine, or medical device) up to 30 days before the first dose administration (Day -30 to Day 1), or their planned use during the study period (up to Visit 6).
  • Previous vaccination with the study antigen (RSV), including investigational RSV vaccines.
  • Unexpected vaccine administration during a study should not occur 30 days prior to the first dose or 30 days after the last dose. For COVID-19 and inactivated/subunit/split influenza vaccines, this window is shortened to 14 days.
  • Prior/Concurrent clinical study experience:
  • Concurrently participating in another active clinical study
  • Other exclusion criteria:
  • Pregnant or lactating female participant.
  • Female participant planning to become pregnant or planning to discontinue contraceptive precautions.
  • History of chronic alcohol consumption and/or drug abuse
  • Participation of any study personnel or their immediate dependents.
  • Planned move during the study period that will prohibit participating in the study until study end.
  • Specific exclusion criteria for renal/lung transplant patients:
  • More than one organ transplanted. Dual organ is allowed.
  • History of events that may put the participant at increased risk for chronic allograft dysfunction.
  • Participant with an episode of allograft rejection over the previous 90 days prior to the first study intervention administration.
  • 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 may put the participant at increased risk.
  • Any confirmed or suspected HIV infection, primary immunodeficiency disease or ongoing CMV infection with a viremia >200 IU/mL.
  • Use of anti-CD20 or other B-cell monoclonal antibody agents for the prevention of allograft rejection within 274 days of first dose of study.
  • Use of investigational and non-registered immunosuppressants at the local/country level, unless specifically prescribed for the prevention of allograft rejection, and which are in process of approval, approved in other countries and locally available.
  • Evidence/high suspicion\ of noncompliance/nonadherence to use of induction and/or maintenance immunosuppressive therapies.
  • Any clinically significant hematologic and/or biochemical laboratory abnormality.
  • Specific exclusion criteria for RTx patients:
  • Previous allograft loss secondary to recurrent primary kidney disease. Multiple consecutive kidney transplants are allowed if the reason is not recurrent primary kidney disease.
  • Evidence of significant proteinuria/albuminuria.
  • Specific exclusion criteria for LTx patients:
  • At study intervention administration visit, diagnosis of documented acute pulmonary infection within the 2 prior weeks.
  • Patients with diagnosis of chronic lung allograft dysfunction (decrement of >=20% in FEV1 compared to post-transplant baseline FEV1).
  • Specific exclusion criteria for healthy participants:
  • Any confirmed/suspected immunosuppressive/immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
  • Unstable serious chronic illness.
  • Chronic administration of immune-modifying drugs (>14 days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the end of the study.
  • Up to 3 months prior to the study intervention administration:
  • For corticosteroids -prednisone equivalent ≥20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed.
  • Administration of immunoglobulins and/or any blood products or plasma derivatives.
  • Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs.

Trial locations and contacts

46 sites in 8 countries.

46 sites in 8 countries

United States10 sites

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Lexington, Kentucky, 40536

  • GSK Investigational Site

    Minneapolis, Minnesota, 55455

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    New York, New York, 10065

  • GSK Investigational Site

    Omaha, Nebraska, 68198-2456

  • GSK Investigational Site

    Phoenix, Arizona, 85013

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Temple, Texas, 76502

Other trials in United States

Spain10 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Barcelona, 08907

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28222

  • GSK Investigational Site

    Santander, 39011

Other trials in Spain

Japan8 sites

  • GSK Investigational Site

    Aichi, 466-8650

  • GSK Investigational Site

    Aichi, 470-1192

  • GSK Investigational Site

    Fukuoka, 814-0180

  • GSK Investigational Site

    Hyōgo, 662-0918

  • GSK Investigational Site

    Kumamoto, 861-8520

  • GSK Investigational Site

    Okayama, 700-8558

  • GSK Investigational Site

    Tokyo, 160-0017

  • GSK Investigational Site

    Tokyo, 193-0998

Other trials in Japan

Canada5 sites

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2B7

  • GSK Investigational Site

    London, Ontario, N6A 5A5

  • GSK Investigational Site

    Sherbrooke, Quebec, J1J 2G2

  • GSK Investigational Site

    Toronto, Ontario, M5G 2N2

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Italy5 sites

  • GSK Investigational Site

    Milan, 20122

  • GSK Investigational Site

    Milan, 20132

  • GSK Investigational Site

    Palermo, 90127

  • GSK Investigational Site

    Pavia, 27100

  • GSK Investigational Site

    Siena, 53100

Other trials in Italy

Australia4 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Birtinya, Queensland, 4556

  • GSK Investigational Site

    Camperdown, New South Wales, 2050

  • GSK Investigational Site

    Herston, Queensland, 4029

Other trials in Australia

South Korea3 sites

  • GSK Investigational Site

    Seoul, 03722

  • GSK Investigational Site

    Seoul, 110-774

  • GSK Investigational Site

    Seoul, 138-736

Other trials in South Korea

Germany1 site

  • GSK Investigational Site

    Giessen, 35392

Other trials in Germany

About this study

Official title: A Phase 2b, Randomized, Controlled, Open-label Study to Evaluate the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults (>=18 Years of Age) When Administered to Lung and Renal Transplant Recipients Comparing 1 Versus 2 Doses and Compared to Healthy Controls (>=50 Years of Age) Receiving 1 Dose.

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.

Being tested
RSVPreF3 OA Investigational Vaccine
Keywords
Respiratory syncytial virus, Vaccine, 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

    0.5 mililiter dose was administered intramuscularly as 1 dose to RSV_IC_1 and RSV_HA groups, and 2 doses to RSV_IC_2 group.

Study groups in NCT05921903
Study groupRoleWhat they receive
RSV_IC_1 groupExperimentalImmunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
Receives: Biological: RSVPreF3 OA Investigational Vaccine
RSV_IC_2 groupExperimentalIC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).
Receives: Biological: RSVPreF3 OA Investigational Vaccine
RSV_HA groupActive comparatorHealthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
Receives: Biological: RSVPreF3 OA Investigational Vaccine

What is being measured

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

  1. RSV-A Serum Neutralizing Titers Expressed As Mean Geometric Increase (MGI) Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group

    MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-A post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).

    Measured: At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)

  2. RSV-B Serum Neutralizing Titers Expressed As MGI Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group

    MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-B post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).

    Measured: At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)

Secondary outcomes (18)

  1. RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups

    Neutralizing titers were calculated as GMT and expressed in titers (Estimated Dilution 60 [ED60]).

    Measured: At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 in a subset of participants (Visit 1+ 7-14 days), Visit 3 (Visit 1+ 30-60 days), Visit 4 (Visit 3+ 30-42 days), Visit 5 (last dose+ 180-210 days) and Visit 6 (last dose+ 350-380 days)

  2. RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups

    Group GMT was assessed for RSV_HA group over pooled RSV_IC group (combined RSV_IC_1 and RSV_IC_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_HA and Pooled RSV_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.

    Measured: At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)

  3. RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups

    Group GMT of RSV_IC_2 over RSV_IC_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_IC_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.

    Measured: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)

  4. RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups

    Group GMT of RSV_HA over RSV_IC_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.

    Measured: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)

  5. RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups

    Group GMT of RSV_HA over RSV_IC_2 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_2 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.

    Measured: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)

  6. RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups

    Group GMT was assessed for RSV_HA group over pooled RSV_IC group (combined RSV_IC_1 and RSV_IC_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_HA and Pooled RSV_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.

    Measured: At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)

  7. RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups

    Group GMT ratio of RSV_IC_2 over RSV_IC_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_IC_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.

    Measured: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)

  8. RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups

    Group GMT of RSV_HA over RSV_IC_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.

    Measured: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)

  9. RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups

    Group GMT of RSV_HA over RSV_IC_2 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_2 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.

    Measured: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)

  10. RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI

    MGI was assessed at Visit 2 (in a subset of participants) over Visit 1 and Visit 3 over Visit 1 in RSV_HA and pooled RSV_IC (combined RSV_IC_1 and RSV_IC_2 groups), and at Visit 4, Visit 5 and Visit 6 over Visit 1 in RSV_IC_1, RSV_IC_2, RSV_HA groups.

    Measured: At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days), Visit 3 (Visit 1 + 30-60 days), Visit 4 (Visit 3 + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days), each compared to Visit 1 (Day 1)

  11. Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells

    CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific cluster of differentiation CD4+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV_IC_1 and RSV_IC_2 groups) and healthy participants (from RSV_HA group).

    Measured: At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days), Visit 4 (Visit 3 + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)

  12. CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells

    CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV_IC_1 and RSV_IC_2 groups) and healthy participants (from RSV_HA group).

    Measured: At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days), Visit 4 (Visit 3 + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)

  13. Number Of Participants Reporting Any Solicited Administration Site Events

    Assessed solicited administration site events included pain, erythema (redness) and swelling, at the injection site. Any = occurrence of the symptom regardless of intensity grade.

    Measured: Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)

  14. Number Of Participants Reporting Any Solicited Systemic Events

    Assessed solicited systemic events included fever (pyrexia), myalgia, arthralgia, headache, and fatigue. Fever is defined as body temperature greater or equal to (≥) 38 degrees Celsius (ºC). Any = occurrence of the symptom regardless of intensity grade.

    Measured: Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)

  15. Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration

    An unsolicited AE is an AE that was not included in the list of solicited events. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.

    Measured: Within 30 days (i.e., the day of vaccination and 29 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)

  16. Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs

    A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of intensity grade or relation to study intervention. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of intensity grade or relation to study intervention.

    Measured: From Visit 1 (Day 1) up to Visit 6 (last dose + 350-380 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)

  17. Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention

    pIMDs are a subset of 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 intensity grade or relation to study intervention. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.

    Measured: From Visit 1 (Day 1) up to Visit 6 (last dose + 350-380 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)

  18. Number Of Participants With Any AEs Of Special Interest (AESIs) Specific To Renal And Lung Solid Organ Transplant (SOT) Participants

    AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV_IC_1 and RSV_IC_2 groups.

    Measured: From Visit 1 (Day 1) up to Visit 6 (last dose + 350-380 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)

Timeline

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

  1. First posted27 Jun 2023
  2. Study start28 Jul 2023
  3. Primary completion25 Jun 2024
  4. Study completion16 May 2025

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
386 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05921903
Sponsor's protocol ID
219900
Other IDs
2023-503951-81-00, 2023
Acronym
RSV OA=ADJ-023
Status last verified
May 2026
First submitted
16 Jun 2023
Last updated
11 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Study Sponsor 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/gsk-patient-level-data-sharing-july2025.pdf

Publications

  • Vyse A, Hockey C, Wright H, Ellsbury G. Could more adults than just those aged 75-79 years potentially benefit from vaccination against RSV: insights from UK data. J Pharm Policy Pract. 2025 Nov 4;18(1):2576618. doi: 10.1080/20523211.2025.2576618. eCollection 2025.

    PubMed 41199924

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RSVPreF3 OA Investigational Vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 46 sites in 8 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 19 inclusion and 48 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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Spain, Japan, Canada, Italy and 3 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 16 Jul 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?

RSV-A Serum Neutralizing Titers Expressed As Mean Geometric Increase (MGI) Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group (time frame: At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)). The study lists 2 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 NCT05921903, 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 11 Jun 2026.

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