RESPIRATORY SYNCYTIAL VIRUS, GLYCOPROTEIN F, RECOMBINANT, STABILISED IN THE PRE-FUSION CONFORMATION, ADJUVANTED WITH AS01E for Respiratory syncytial virus infection

Inclusion criteria

• {"criterion_text":"- Participants of the RSV OA=ADJ-023 study from the Per Protocol Set, who received either 1 or 2 doses of the adjuvanted RSVPreF3 vaccine and for whom the immunogenicity data are available.\n- Participants who, in the opinion of the investigator, 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).\n- Written or witnessed informed consent obtained participant prior to performance of any study-specific procedure.\n- 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. Refer to Protocol Section 10.4.1 for definitions of women of childbearing potential, menarche and menopause.\n- Female participants of childbearing potential may be enrolled in the study if the participant: \thas practiced adequate contraception from 1 month prior to study intervention administration, and \tagreed to continue adequate contraception until 1 month after study intervention, and \thas a negative pregnancy test on the day of and prior to study intervention administration. Refer to Protocol Section 10.4.2 for definition of adequate contraception.\n- 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.\n- Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection.\n- For kidney transplant 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.\n- For lung transplant 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

• {"criterion_text":"- Any history of dementia or any medical condition that moderately or severely impairs cognition.\n- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study\n- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention\n- Acute or chronic clinically significant cardiovascular or hepatic functional abnormality, as determined by physical examination or laboratory screening tests.\n- Recurrent or uncontrolled neurological disorders or seizures.\n- Any condition which, in the judgment of the investigator, would make IM injection unsafe.\n- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.\n- Vaccination with RSV-antigen containing vaccine after 1 or 2 doses received in the parent study\n- 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\n- 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.\n- 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\n- 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.\n- Any study personnel or their immediate dependents, family, or household members.\n- Planned move during the study period that will prohibit participating in the study until study end.\n- Pregnant or lactating female participant.\n- Female participant planning to become pregnant or planning to discontinue contraceptive precautions.\n- More than one organ transplanted (i.e., kidney-liver or kidney-other organ(s) transplanted). Dual organ is allowed (double kidney or double lung).\n- History of events that, in the opinion of the investigator, may put the participant at increased risk for chronic allograft dysfunction.\n- Participant with an episode of allograft rejection within 3 months (90 days) prior to Visit 1.\n- Histologic evidence of chronic allograft injury.\n- Active treatment for acute rejection.\n- Current diagnosis of malignancy (except non-melanoma skin cancer that does not require systemic therapy).\n- Any autoimmune conditions or pIMDs that in the opinion of the investigator may put the participant at increased risk.\n- Any confirmed or suspected HIV infection or primary immunodeficiency disease or ongoing CMV infection with a viremia > 200 IU/mL\n- Use of anti-CD20 or other B-cell monoclonal antibody agents for the prevention of allograft rejection within 9 months prior to Visit 1.\n- Use of investigational and non-registered immunosuppressants\n- Evidence or suspicion of noncompliance or nonadherence to immunosuppressive therapy\n- Any clinically significant hematologic and/or biochemical laboratory abnormality\n- Previous allograft loss secondary to recurrent primary kidney disease\n- Evidence of significant proteinuria/albuminuria\n- Diagnosis of acute pulmonary infection within the 2 weeks\n- Chronic lung allograft dysfunction"}

Primary endpoints

• {"endpoint_text":"- RSV-A and RSV-B serum neutralizing titers expressed as GMT at Visit 1 in IC-1 and IC-2 groups.\n- RSV-A and RSV-B serum neutralizing titers expressed as MGI at Visit 1 in the current study over 30 days post last dose in the parent study in IC-1 and IC-2 groups.\n- RSV-A and RSV-B serum neutralizing titers expressed as GMT in IC-1 and IC-2 groups at Visit 2 and Visit 3.","definition_or_measurement_approach":"Measured as serum neutralizing antibody titers against RSV-A and RSV-B; results expressed as geometric mean titers (GMT) or mean geometric increase (MGI) at specified visits (Visit 1, Visit 2, Visit 3) and comparisons versus 30 days post last dose in the parent study, by study group (IC-1 and IC-2)."}

Secondary endpoints

• {"endpoint_text":"- RSV-A and RSV-B serum neutralizing titers expressed as group GMT ratio IC-2 over IC-1 at Visit 1.","definition_or_measurement_approach":"Group comparison of serum neutralizing titers for RSV-A and RSV-B expressed as geometric mean titer (GMT) ratio (IC-2 / IC-1) at Visit 1."}
• {"endpoint_text":"- RSV-A and RSV-B serum neutralizing titers expressed as MGI at Visit 2 and Visit 3 over Visit 1 in IC-1 and IC-2 groups.","definition_or_measurement_approach":"Mean geometric increase (MGI) of serum neutralizing titers for RSV-A and RSV-B at Visit 2 and Visit 3 relative to Visit 1, within IC-1 and IC-2 groups."}
• {"endpoint_text":"- RSV-A and RSV-B serum neutralizing titers expressed as MGI at Visit 2 in the RSV-031 study over 30 days post last dose in the parent study in IC-1 and IC-2 groups.","definition_or_measurement_approach":"MGI of serum neutralizing titers at Visit 2 compared with 30 days post last dose in the parent study, for RSV-A and RSV-B, within IC-1 and IC-2 groups."}
• {"endpoint_text":"- Percentage of participants reporting: - each solicited administration site event with onset within 7 days after receiving the re-vaccination dose - each solicited systemic event with onset within 7 days after receiving the re-vaccination dose • unsolicited AEs within 30 days after receiving the re-vaccination dose • any SAEs after receiving the re-vaccination dose up to Visit 3 (Month 6) • related SAEs after receiving the re-vaccination dose up to study end (Month 12)","definition_or_measurement_approach":"Safety/reactogenicity measured by percentage of participants reporting solicited local and systemic events within 7 days post-revaccination, unsolicited adverse events within 30 days, any serious adverse events up to Visit 3 (Month 6), and related SAEs up to study end (Month 12)."}
• {"endpoint_text":"- Percentage of participants reporting: -fatal SAEs after receiving the re-vaccination dose of the adjuvanted RSVPreF3 vaccine up to study end (Month 12) -AESIs (AEs specific to kidney and lung SOT patients and pIMDs) after receiving the re-vaccination dose up to study end (Month 12)","definition_or_measurement_approach":"Safety endpoints expressed as percentage of participants with fatal serious adverse events and percentage with adverse events of special interest (AESIs) up to study end (Month 12)."}

Germany

Earliest CTIS Part Ii Submission Date

04-09-2025

Latest Decision Or Authorization Date

24-04-2026

Processing Time Days

232

Number Of Sites

1

Number Of Participants

8

Spain

Earliest CTIS Part Ii Submission Date

27-08-2025

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

236

Number Of Sites

9

Number Of Participants

45

Italy

Earliest CTIS Part Ii Submission Date

05-08-2025

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

276

Number Of Sites

5

Number Of Participants

18

Primary sponsor

Full Name

GlaxoSmithKline Biologicals

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Sermes CRO

Responsibilities

Patient fee reimbursement

Name

IQVIA Limited

Name

Trial Form Support S.L.

Responsibilities

Site Coordination Services, including data management

Third parties

• {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"Medicine product destruction","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Akkodis Belgium","duties_or_roles":"IDMC Secretary","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"DHL Supply Chain (Ireland) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"HCL Technologies UK Limited","duties_or_roles":"Sample management support (Site2Test)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Spain","full_name":"Trial Form Support S.L.","duties_or_roles":"Site Coordination Services, including data management","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"Clinical Trial Ancillary supplies","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"ZALARIS Deutschland GmbH","duties_or_roles":"Patient Reimbursement","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"Patient fee reimbursement","organisation_type":"Pharmaceutical company"}