Healthy volunteers (Active immunization for the prevention of disease caused by RSV in adults aged 60 years or above) MedDRA version: 21.1 Level: PT Classification code 10035732 Term: Pneumonia respiratory syncytial viral System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: PT Classification code 10038718 Term: Respiratory syncytial virus bronchiolitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: PT Classification cod
Conditions
Interventions
Trade Name: Arexvy
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN: NA
Current Sponsor code: GSKVx000000017064
Other descriptive name: Recombinant respirato
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female participants =60 YOA at first vaccination, who live in the community (CD participants) or in a Long-term care facility (LTCF participants). • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. • Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure. • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 330 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 1320
Exclusion criteria
Exclusion criteria: Medical conditions • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. • Hypersensitivity to latex. • Serious or unstable chronic illness. • 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. • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. • Any history of dementia or any medical condition that moderately or severely impairs cognition. Prior/Concomitant therapy • Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or planned use during the study period. • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated, split virion and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination. • Previous vaccination with an RSV vaccine. • Administration of long-acting immune-modifying drugs or planned administration at any time during the study period. • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine or planned administration during the study period. • Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine dose or planned administration during the study period. For corticosteroids, this will mean prednisone =20 mg/day, or equivalent. Inhaled and topical steroids are allowed. 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 vaccine/product. Other exclusions • 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. • Bedridden participants. • Planned move during the study period that will prohibit participation in the trial until the study end. This includes: • Planned move during the study period to another LTCF that will prohibit participation in the trial until study end. • Planned move from the community to a LTCF that will prohibit participation in the trial until study end. • Participation of any study personnel or their immediate dependants, family, or household members.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the humoral immune response following a 1-dose primary schedule of RSVPreF3 OA investigational vaccine up to 12 months post-Dose 1.;Secondary Objective: • To further evaluate the humoral immune response following a 1-dose primary schedule of RSVPreF3 OA investigational vaccine up to 12 months post-Dose 1. • To evaluate the humoral immune response following 1 dose of the RSVPreF3 OA investigational vaccine and following revaccination doses, up to study end. • To evaluate the cell-mediated immune (CMI) response following 1 dose of the RSVPreF3 OA investigational vaccine and following revaccination doses up to study end. • To evaluate the safety and reactogenicity of each vaccination schedule of the RSVPreF3 OA investigational vaccine in all participants.;Primary end point(s): 1, 2, 3, 4. Humoral immune response in terms of RSV-A neutralizing antibody Geometric Mean Titers (GMTs) 5, 6, 7, 8. Humoral immune response in terms of RSV-B neutralizing antibody titers;Timepoint(s) of evaluation of this end point: 1, 5. At Day 1 (pre-vaccination) 2, 6. At Day 31 3, 7. At Month 6 4, 8. At Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1, 2, 3, 4. Humoral immune response in terms of RSVPreF3-binding Immunoglobulin G (IgG) antibody geometric mean concentrations (GMCs) 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16. Humoral immune response in terms of RSV-A neutralizing antibody GMTs 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28. Humoral immune response in terms of RSV-B neutralizing antibody titers 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40. Humoral immune response in terms of RSVPreF3 IgG antibody GMCs 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56. CMI response in terms of frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ and/or CD8+ T cells expressing at least 2 activation markers 57, 58, 59, 60, 61. Number of participants with at least one solicited administration-site event and solicited systemic event 62, 63, 64, 65, 66. Number of participants with any unsolicited adverse events (AEs) 67, 68, 69, 70, 71. Number of participants with serious adverse events (SAEs) 72, 73, 74, 75, 76. Number of participants reporting any potential immune-mediated disease (pIMD) 77. Number of participants with a fatal SAE, related SAE and related pIMDs Timeframes: 1, 41. At Day 1 (pre-vaccination) 2, 42. At Day 31 3, 43. At Month 6 4, 44. At Month 12 5, 17, 29, 45. At Month 18 6, 18, 30, 46. At Month 24 7, 19, 31, 47. At Month 30 8, 20, 32, 48. At Month 36 9, 21, 33, 49. At Month 42 10, 22, 34, 50. At Month 48 11, 23, 35, 51. At Month 54 12, 24, 36, 52. At Month 60 13, 25, 37, 53. At Month 13 14, 26, 38, 54. At Month 25 15, 27, 39, 55. At Month 37 16, 28, 40, 56. At Month 49 57. During the 4 days (including the day of vaccination) following vaccination at Day 1 58. During the 4 days (including the day of vaccination) following vaccination at Month 12 59. During the 4 days (including the day of vaccination) following vaccination at Month 24 60. During the 4 days (including the day of vaccination) following vaccination at Month 36 61. During the 4 days (includi | — |
Countries
Finland, Germany, Japan, Taiwan, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals SA
Outcome results
None listed