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 (RSV OA=ADJ-023)

December 13, 2023 updated by: GlaxoSmithKline

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

375

Phase

  • 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 Backup

Study Locations

  • Australia
    • 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:
          • Krispin Hajkowicz
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Toby Coates
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew McLean-Tooke
  • 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
    • Quebec
      • Montreal, Quebec, Canada, H2X 3H9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Fantus
      • Sherbrooke, Quebec, Canada, J1J 2G2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Sebastien Gauthier
  • Germany
    • Hessen
      • Giessen, Hessen, Germany, 35392
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hristos Karakizlis
    • Rheinland-Pfalz
      • Kaiserslautern, Rheinland-Pfalz, Germany, 67655
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Rath
  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Francesco Blasi
        • Contact:
        • Contact:
      • Milano, Lombardia, Italy, 20132
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rossana Caldara
      • Pavia, Lombardia, Italy, 27100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Federica Meloni
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrizio Vitulo
    • Toscana
      • Siena, Toscana, 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:
          • Norihiko Goto
      • Fukuoka, Japan, 814-0180
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takeshi Shiraishi
      • Hyogo, 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
      • Kyoto, Japan, 606-8507
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hiroshi Date
      • Okayama, Japan, 700-8558
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seiichiro Sugimoto
      • Tokyo, Japan, 160-0017
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kenji Takazawa
      • Tokyo, Japan, 193-0998
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hitoshi Iwamoto
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Su Jin Jeong
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sung-Han Kim
        • Contact:
        • Contact:
      • Seoul, Korea, Republic of, 110-774
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pyoeng Gyun Choe
  • Spain
      • A Coruna, Spain, 15006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Jose Pereira Rodriguez
      • Barcelona, Spain, 08036
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Fritz Diekmann
        • Contact:
        • Contact:
      • Barcelona, Spain, 08907
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Cristina Masuet Aumatell
        • Contact:
        • Contact:
      • Córdoba, Spain, 14004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • María Luisa Agüera Morales
      • Madrid, Spain, 28034
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sara Jiménez Álvaro
      • Madrid, Spain, 28040
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ignacio Bardón Fernández-Pacheco
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Pablo Rojo Conejo
        • Contact:
        • Contact:
      • Madrid, Spain, 28007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mª Luisa Rodríguez Ferrero
      • Santander, Spain, 39011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Henar Rebollo Rodrigo
      • Sevilla, Spain, 41013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Manuel González Roncero
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jenry Borda Olivas
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rajat Walia
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Scott Borgetti
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dilek Ince
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Richard N. Greenberg
        • Contact:
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jo-Anne Hertha Young
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tarek Alhamad
        • Contact:
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2456
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Natalia Castillo Almeida
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Catherine B Small
      • New York, New York, United States, 10032
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Magdalena Sobieszczyk
    • 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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:

  • 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.

Exclusion Criteria:

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.
  • 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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RSV_IC_1 group
Immunocompromised (IC) patients receiving 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
Biological: RSVPreF3 OA Investigational Vaccine
The investigational vaccine will be administered intramuscularly as 1 dose to RSV_IC_1 and RSV_HA groups, and 2 doses to RSV_IC_2 group).
Experimental: RSV_IC_2 group
Immunocompromised (IC) patients receiving 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).
Biological: RSVPreF3 OA Investigational Vaccine
The investigational vaccine will be administered intramuscularly as 1 dose to RSV_IC_1 and RSV_HA groups, and 2 doses to RSV_IC_2 group).
Active Comparator: RSV_HA group
Healthy participants receiving 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
Biological: RSVPreF3 OA Investigational Vaccine
The investigational vaccine will be administered intramuscularly as 1 dose to RSV_IC_1 and RSV_HA groups, and 2 doses to RSV_IC_2 group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RSV-A serum neutralizing titers expressed as mean geometric increase (MGI) post Dose 2 over post-Dose 1
Time Frame: At Visit 4 (Visit 3 + 30-42 days) versus Visit 3 (Day 30-60)
The analysis is performed on the renal and lung SOT patients in the 2-dose group.
At Visit 4 (Visit 3 + 30-42 days) versus Visit 3 (Day 30-60)
RSV-B serum neutralizing titers expressed as MGI post-Dose 2 over post-Dose 1
Time Frame: At Visit 4 (Visit 3 + 30-42 days) versus Visit 3 (Day 30-60)
The analysis is performed on the renal and lung SOT patients in the 2-dose group.
At Visit 4 (Visit 3 + 30-42 days) versus Visit 3 (Day 30-60)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cell Mediated Immunity (CMI) response in a subset of participants
Time Frame: At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-α, IFN-γ, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from 1-dose group and 2-dose group) and healthy participants.
At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
Percentage of participants with solicited administration site events
Time Frame: Within 7 days post-study intervention administration (i.e., the day of vaccination and 6 subsequent days, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
Assessed solicited administration site events included pain, redness and swelling, at the injection site.
Within 7 days post-study intervention administration (i.e., the day of vaccination and 6 subsequent days, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
Percentage of participants with unsolicited adverse events (AEs)
Time Frame: Within 30 days post-study intervention administration (i.e., the day of vaccination and 29 subsequent days, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
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.
Within 30 days post-study intervention administration (i.e., the day of vaccination and 29 subsequent days, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
Percentage of participants with any AESIs
Time Frame: From Day 1 up to study end (Day 350-380 post last dose, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
AESIs are AEs of special interest. Along with pIMDs, they include also the acute rejection (specific to renal and lung SOT patients) and Atrial fibrillation (AF).
From Day 1 up to study end (Day 350-380 post last dose, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
RSV-A serum neutralizing titers expressed as Geometric Mean Titers
Time Frame: At Visit 2 in a subset of participants (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
The analysis is performed on the renal and lung SOT patients and healthy participants.
At Visit 2 in a subset of participants (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
RSV-B serum neutralizing titers expressed as Geometric Mean Titers
Time Frame: At Visit 2 in a subset of participants (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
The analysis is performed on the renal and lung SOT patients and healthy participants.
At Visit 2 in a subset of participants (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
RSV-A serum neutralizing titers expressed as group geometric mean titers (GMT) ratio
Time Frame: At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
Group GMT ratio of RSV_HA group over RSV_IC group (pooled RSV_IC_1 and RSV_IC_2 groups) is assessed at Visit 2 (in a subset of participants) and Visit 3, and RSV_IC_2 over RSV_IC_1, RSV_HA over RSV_IC_1 and RSV_HA over RSV_IC_2 at Visit 4, Visit 5 and Visit 6.
At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
RSV-B serum neutralizing titers expressed as group geometric mean titers (GMT) ratio
Time Frame: At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
Group GMT ratio of RSV_HA group over RSV_IC group (pooled RSV_IC_1 and RSV_IC_2 groups) is assessed at Visit 2 (in a subset of participants) and Visit 3, and RSV_IC_2 over RSV_IC_1, RSV_HA over RSV_IC_1 and RSV_HA over RSV_IC_2 at Visit 4, Visit 5 and Visit 6.
At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
RSV-A serum neutralizing titers expressed as mean geometric increase (MGI)
Time Frame: At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
MGI is assessed at Visit 2 (in a subset of participants) over Visit 1 and Visit 3 over Visit 1 in RSV_HA and RSV_IC (pooled 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_2, RSV_HA groups.
At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
RSV-B serum neutralizing titers expressed as mean geometric increase (MGI)
Time Frame: At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
MGI is assessed at Visit 2 (in a subset of participants) over Visit 1 and Visit 3 over Visit 1 in RSV_HA and RSV_IC (pooled 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_2, RSV_HA groups.
At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
Percentage of participants with solicited systemic events
Time Frame: Within 7 days post-study intervention administration (i.e., the day of vaccination and 6 subsequent days, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
Assessed solicited systemic events included fever, myalgia, arthralgia, headache, and fatigue.
Within 7 days post-study intervention administration (i.e., the day of vaccination and 6 subsequent days, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
Percentage of participants with any serious adverse events (SAEs) after study intervention, SAEs related to study intervention and fatal SAEs
Time Frame: From Day 1 up to study end (Day 350-380 post last dose, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
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.
From Day 1 up to study end (Day 350-380 post last dose, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
Percentage of participants with any potential immune-mediated disease (pIMDs) after study intervention and pIMDs related to study intervention
Time Frame: From Day 1 up to study end (Day 350-380 post last dose, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
Potential immune-mediated diseases (pIMDs) are a subset of AEs 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.
From Day 1 up to study end (Day 350-380 post last dose, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)

Collaborators and Investigators

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

Sponsor

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)

July 28, 2023

Primary Completion (Estimated)

September 9, 2024

Study Completion (Estimated)

August 13, 2025

Study Registration Dates

First Submitted

June 16, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 219900
  • 2023-503951-81-00 (Other Identifier: EU CT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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 terminated asset(s) 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

product manufactured in and exported from the U.S.

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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