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

Inclusion criteria

• {"criterion_text":"- Male or female participants ≥60 YOA at first vaccination, who live in the community (CD participants) or in a LTCF (LTCF participants)."}
• {"criterion_text":"- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, attend regular phone calls/study site visits, ability to access and utilize a phone or other electronic communications)."}
• {"criterion_text":"- Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure."}
• {"criterion_text":"- Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Patients with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable."}

Exclusion criteria

• {"criterion_text":"- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination"}
• {"criterion_text":"- Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol"}
• {"criterion_text":"- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study"}

Primary endpoints

• {"endpoint_text":"- Humoral immune response at pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), and at 6 and 12 months post-Dose 1 (Months 6 and 12), in a subset of participants: Neutralizing titers against RSV-A. Neutralizing titers against RSV-B.","definition_or_measurement_approach":"Measurement of neutralizing antibody titers against RSV-A and RSV-B at specified timepoints (Day 1, Day 31, Month 6, Month 12) in a subset of participants."}

Secondary endpoints

• {"endpoint_text":"- Humoral immune response at pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), and at 6 and 12 months post-Dose 1 (Months 6 and 12), in a subset of participants: RSVPreF3-binding Immunoglobulin G (IgG) antibody concentrations.","definition_or_measurement_approach":"Measurement of RSVPreF3-binding IgG antibody concentrations at specified timepoints (Day 1, Day 31, Month 6, Month 12) in a subset of participants."}
• {"endpoint_text":"- Humoral immune response at Months 18, 24, 30, 36, 42, 48, 54 and 60 post-Dose 1, and at 1 month after each revaccination dose (Months 13, 25, 37 and 49), in a subset of participants: Neutralizing titers against RSV-A and RSV-B RSVPreF3-binding IgG antibody concentrations.","definition_or_measurement_approach":"Longitudinal measurement of neutralizing titers against RSV-A and RSV-B and RSVPreF3-binding IgG antibody concentrations at extended timepoints through Month 60 and following revaccination doses."}
• {"endpoint_text":"- CMI response at pre-vaccination (Day 1), 30 days post Dose 1 (Day 31), at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 post-Dose 1, and after each revaccination dose (Months 13, 25, 37, 49, 61, 66 and 72), in a subset of participants: 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-, IFN-, IL-13, IL-17.","definition_or_measurement_approach":"Cell-mediated immunity assessed by measuring frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing ≥2 activation markers (including listed cytokines) at specified timepoints up to Month 72 in a subset."}
• {"endpoint_text":"- •\tOccurrence of each solic. admin. site + systemic event during a 4-day Fup period (i.e., on the day of vaccination and 3 subsequent days) after each vaccination. •\tOccurrence of any unsolic. AE during a 30-day Fup period (i.e., on the day of vaccination and 29 subsequent days) after each vaccination. •\tOccurrence of all SAEs and pIMDs up to 6 months after each vaccination. •\tOccurrence of fatal SAEs, related SAEs and related pIMDs from first vaccination (D1) up to study end (M72).","definition_or_measurement_approach":"Safety and reactogenicity assessed via solicited local and systemic events (4-day follow-up), unsolicited AEs (30-day follow-up), SAEs and potential immune-mediated diseases up to 6 months post-vaccination, and fatal/related SAEs and related pIMDs from Day 1 to study end (Month 72)."}

Methods

• Site-based recruitment at participating clinics and research centers (local FVR clinics and participating study centers listed in country Part II trialSites).
• Decentralised clinical trial support / mobile nursing provided by Accellacare Limited ("Decentralised Clinical Trial - Mobile nursing").
• Patient recruitment and retention materials provided by Matthews Media Group Inc.
• Use of recruitment arrangements materials (K1 recruitment brochure/poster/blurb documents) and local recruitment texts (K2 Local texts for recruitment_redacted).

Finland

Earliest CTIS Part Ii Submission Date

22-05-2024

Latest Decision Or Authorization Date

03-10-2025

Processing Time Days

499

Number Of Sites

8

Number Of Participants

350

Germany

Earliest CTIS Part Ii Submission Date

22-05-2024

Latest Decision Or Authorization Date

04-09-2025

Processing Time Days

470

Number Of Sites

8

Number Of Participants

388

Primary sponsor

Full Name

GlaxoSmithKline Biologicals

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Third parties

• {"country":"Germany","full_name":"Labor Berlin Charite Vivantes GmbH","duties_or_roles":"PBMC preparation lab","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Finland","full_name":"Tamro Oyj","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Accellacare Limited","duties_or_roles":"Decentralised Clinical Trial - Mobile nursing","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Sample Management","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"PBMC preparation lab","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Matthews Media Group Inc.","duties_or_roles":"Patient recruitment and retention materials","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Meeting Organization","organisation_type":"Pharmaceutical company"}