Clinical trial NCT05879107: Study to Assess the Immune Response, the Safety and the Reactogenicity of Respiratory Syncytial Virus (RSV) Prefusion Protein 3 Older Adult (OA) (RSVPreF3 OA) Investigational Vaccine When co Administered With PCV20 in Older Adults
Official title: A Phase III, Open-label, Randomized, Controlled, Multi-Country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co Administered With PCV20 in Adults Aged 60\xa0Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory syncytial virus
Vaccine
Older adult
Immunogenicity
Safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2023-05-30
Enrollment: 1113
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 ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with PCV20 and its safety in older adults, aged ≥60 years of age.


Eligibility criteria: Inclusion Criteria:

* A male or female ≥60 years of age at the time of the first study intervention administration.
* 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 any study-specific procedure being performed.
* Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self care and activities of daily living.
* 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, are allowed to participate in this study if considered by the investigator as medically stable.

Exclusion Criteria:

* 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 the study interventions, in particular any history of severe allergic reaction to any vaccine containing diphtheria toxoid, or pneumococcal polysaccharide 23-valent vaccine (PPSV23).
* Participants considered by investigator as suffering from serious or unstable chronic illness.
* Any history of dementia or any medical condition that moderately or severely impairs cognition.
* Recurrent or uncontrolled 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.
* History of previous vaccination with any licensed or investigational pneumococcal conjugate vaccine, or planned receipt through study participation.
* History of previous vaccination with any licensed or investigational pneumococcal polysaccharide vaccine in the last 5 years from enrollment, or planned receipt through study participation.
* Previous vaccination with any licensed or investigational RSV vaccine
* Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions and ending 30 days after the last study intervention administration, or their 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 the first study intervention administration and ending 30 days after the last study intervention administration. In the case of COVID 19 and inactivated/subunit influenza vaccines, this time window can be decreased to 14 days before and after each study intervention administration. In case of COVID-19 vaccine administration within 14 to 30 days window, the administration of COVID-19 vaccine should be in accordance with local government recommendations.

  * Planned or actual administration of adjuvanted quadrivalent influenza vaccine or live influenza vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration.

Note: In case an emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by the public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor or designee is notified accordingly.

* 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 administration of first dose of study interventions 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 study intervention 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.
* 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 (drug or invasive medical device).
* 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 conduct that prohibits participation until EoS.
* Participation of any study personnel or their immediate dependents, family, or household members.

Primary outcomes:
measure: Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
timeFrame: At Day 31
measure: Adjusted GMTs of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination
timeFrame: At Day 31 for Co-administration Group and at Day 61 for Control Group
measure: Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination
timeFrame: At Day 31 for Co-administration Group and at Day 61 for Control Group
Secondary outcomes:
measure: Mean Geometric Increase (MGI) of RSV-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
timeFrame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Day 31 for Control Group)
measure: MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
timeFrame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Day 31 for Control Group)
measure: Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
timeFrame: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)
measure: Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
timeFrame: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)
measure: Number of Participants With Unsolicited AEs
timeFrame: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)
measure: Number of Participants With SAEs
timeFrame: Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-administration Group and Day 31 for Control Group])
measure: Number of Participants With Potential Immune-mediated Diseases (pIMDs)
timeFrame: Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-administration Group and Day 31 for Control Group])
Other outcomes:
Locations:
city: Guntersville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Modesto
country: United States
facility: GSK Investigational Site
state: California
city: Hamden
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: DeLand
country: United States
facility: GSK Investigational Site
state: Florida
city: Jupiter
country: United States
facility: GSK Investigational Site
state: Florida
city: Largo
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: West Des Moines
country: United States
facility: GSK Investigational Site
state: Iowa
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Troy
country: United States
facility: GSK Investigational Site
state: Michigan
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: North Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Frisco
country: United States
facility: GSK Investigational Site
state: Texas
city: Mesquite
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: Antwerpen
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Kluisbergen
country: Belgium
facility: GSK Investigational Site
city: Mechelen
country: Belgium
facility: GSK Investigational Site
city: Namur
country: Belgium
facility: GSK Investigational Site
city: Wetteren
country: Belgium
facility: GSK Investigational Site
city: KrakOw
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Pu?awy
country: Poland
facility: GSK Investigational Site
city: Staszow
country: Poland
facility: GSK Investigational Site
city: Warsaw
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
Study officials:
References: