Clinical trial NCT04732871: Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
Official title: A Phase 3, Randomized, Open-label, Multi-country Study to Evaluate the Immunogenicity, Safety, Reactogenicity and Persistence of a Single Dose of the RSVPreF3 OA Investigational Vaccine and Different Revaccination Schedules in Adults Aged 60 Years and Above
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory syncytial virus
Vaccine
Safety
Reactogenicity
Immunogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-02-01
Enrollment: 1720
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 3 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.


Eligibility 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.

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.

Primary outcomes:
measure: Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1
timeFrame: At Day 1
measure: Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31
timeFrame: At Day 31
measure: Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6
timeFrame: At Month 6
measure: Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12
timeFrame: At Month 12
measure: Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1
timeFrame: At Day 1
measure: Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31
timeFrame: At Day 31
measure: Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6
timeFrame: At Month 6
measure: Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12
timeFrame: At Month 12
Secondary outcomes:
measure: Humoral Immune Response in Terms of RSVPreF3 Immunoglobulin G (IgG) Antibody Geometric Mean Concentrations (GMCs) at Day 1
timeFrame: At Day 1
measure: Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Day 31
timeFrame: At Day 31
measure: Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 6
timeFrame: At Month 6
measure: Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 12
timeFrame: At Month 12
measure: Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 18
timeFrame: At Month 18
measure: Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 24
timeFrame: At Month 24
measure: Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 30
timeFrame: At Month 30
measure: Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 36
timeFrame: At Month 36
measure: Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 13
timeFrame: At Month 13
measure: Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 25
timeFrame: At Month 25
measure: Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 18
timeFrame: At Month 18
measure: Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 24
timeFrame: At Month 24
measure: Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 30
timeFrame: At Month 30
measure: Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 36
timeFrame: At Month 36
measure: Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 13
timeFrame: At Month 13
measure: Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 25
timeFrame: At Month 25
measure: Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 18
timeFrame: At Month 18
measure: Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 24
timeFrame: At Month 24
measure: Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 30
timeFrame: At Month 30
measure: Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 36
timeFrame: At Month 36
measure: Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 13
timeFrame: At Month 13
measure: Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 25
timeFrame: At Month 25
measure: Cell-Mediated Immunity (CMI) Response in Terms of Frequency of RSVPreF3-specific Cluster of Differentiation CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1
timeFrame: At Day 1
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1
timeFrame: At Day 1
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31
timeFrame: At Day 31
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31
timeFrame: At Day 31
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6
timeFrame: At Month 6
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6
timeFrame: At Month 6
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12
timeFrame: At Month 12
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12
timeFrame: At Month 12
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 18
timeFrame: At Month 18
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 18
timeFrame: At Month 18
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 24
timeFrame: At Month 24
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 24
timeFrame: At Month 24
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 30
timeFrame: At Month 30
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 30
timeFrame: At Month 30
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 36
timeFrame: At Month 36
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 36
timeFrame: At Month 36
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13
timeFrame: At Month 13
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13
timeFrame: At Month 13
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 25
timeFrame: At Month 25
measure: CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 25
timeFrame: At Month 25
measure: Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1
timeFrame: During the 4-day follow up period after first vaccination (vaccine administered on Day 1)
measure: Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Month 12
timeFrame: During the 4-day follow up period after vaccination (vaccine administered at Month 12)
measure: Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Month 24
timeFrame: During the 4-day follow up period after vaccination (vaccine administered at Month 24)
measure: Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1
timeFrame: During the 4-day follow up period after vaccination (vaccine administered on Day 1)
measure: Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Month 12
timeFrame: During the 4-day follow up period after vaccination (vaccine administered at Month 12)
measure: Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Month 24
timeFrame: During the 4-day follow up period after vaccination (vaccine administered at Month 24)
measure: Number of Participants With Any Unsolicited Adverse Events (AEs) Following Vaccination at Day 1
timeFrame: During the 30-day follow up period after vaccination (vaccine administered on Day 1)
measure: Number of Participants With Any Unsolicited AEs Following Vaccination at Month 12
timeFrame: During the 4-day follow up period after vaccination (vaccine administered at Month 12)
measure: Number of Participants With Any Unsolicited AEs Following Vaccination at Month 24
timeFrame: During the 4-day follow up period after vaccination (vaccine administered at Month 24)
measure: Number of Participants With Serious Adverse Events (SAE) Following Vaccination at Day 1
timeFrame: From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6)
measure: Number of Participants With SAEs Following Vaccination at Month 12
timeFrame: During the 4-day follow up period after vaccination (vaccine administered at Month 12)
measure: Number of Participants With SAEs Following Vaccination at Month 24
timeFrame: During the 4-day follow up period after vaccination (vaccine administered at Month 24)
measure: Number of Participants Reporting Any Potential Immune-mediated Disease (pIMD) Following Vaccination at Day 1
timeFrame: From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6)
measure: Number of Participants Reporting Any pIMD Following Vaccination at Month 12
timeFrame: During the 4-day follow up period after vaccination (vaccine administered at Month 12)
measure: Number of Participants Reporting Any pIMD Following Vaccination at Month 24
timeFrame: During the 4-day follow up period after vaccination (vaccine administered at Month 24)
measure: Number of Participants With a Fatal SAE, Related SAE and Related pIMDs
timeFrame: From first vaccination (Day 1) up to study end (Month 36)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Riverside
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Coral Gables
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: GSK Investigational Site
state: Florida
city: Sarasota
country: United States
facility: GSK Investigational Site
state: Florida
city: The Villages
country: United States
facility: GSK Investigational Site
state: Florida
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Richfield
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Mount Pleasant
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Wenatchee
country: United States
facility: GSK Investigational Site
state: Washington
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Jarvenpaa
country: Finland
facility: GSK Investigational Site
city: Kokkola
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Pori
country: Finland
facility: GSK Investigational Site
city: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wallerfing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Kumamoto
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Changhua
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan County
country: Taiwan
facility: GSK Investigational Site
Study officials:
References: