Clinical trial NCT05559476: A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above
Official title: A Phase 3, Open-label, Randomized, Controlled, Multicountry Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU HD Vaccine in Adults Aged 65 Years and Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory syncytial virus
High dose quadrivalent influenza vaccine
Immunogenicity
Safety
Reactogenicity
Adults aged 65 years and above
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2022-09-29
Enrollment: 1029
Sex: ALL
Minimum age (years): 65
Standard ages: 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 immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.


Eligibility criteria: Inclusion Criteria:

* Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol
* A male or female ≥65 years of age at the time of the first study intervention administration.
* 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.
* 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. 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:

Medical conditions

* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Hypersensitivity to latex.
* History of Guillain Barré syndrome, or anaphylaxis.
* Serious or unstable chronic illness.
* Any history of dementia or any medical condition that moderately or severely impairs cognition.
* 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 (e.g. completion of diary cards, attend regular phone calls/study site visits).
* 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.

Prior/Concomitant therapy

* 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 study vaccine administration, or planned use during the study period.
* Administration of an influenza vaccine during the 6 months preceding the study FLU vaccine administration.
* 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.

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 is notified accordingly.

* 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 study vaccination 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 intervention (drug/invasive medical device).

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.
* Planned move during the study conduct that prohibits participation until 1 month post-last vaccine administration.
* Bedridden participants.
* Participation of any study personnel or their immediate dependents, family, or household members.

Primary outcomes:
measure: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
timeFrame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
measure: Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs
timeFrame: At 1 month after the FLU vaccine dose (Day 31 for both groups)
measure: RSV-B Neutralizing Titers Expressed as Group GMTs
timeFrame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
Secondary outcomes:
measure: HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
timeFrame: At 1 month after the FLU vaccine dose (Day 31 for both groups)
measure: RSV-A Neutralizing Titers Expressed as Mean Geometric Increase (MGI)
timeFrame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)
measure: RSV-B Neutralizing Titers Expressed as MGI
timeFrame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)
measure: HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT
timeFrame: At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups)
measure: HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
timeFrame: At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups)
measure: HI Titers for 4 FLU Vaccine Strains, Expressed as MGI
timeFrame: At 1 month after the FLU vaccine dose administration (Day 31 for both groups)
measure: Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration
timeFrame: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)
measure: Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration
timeFrame: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)
measure: Percentage of Participants Reporting Unsolicited Adverse Events (AEs)
timeFrame: Within 30 days after vaccine administration (the day of vaccination and 29 subsequent days after vaccination)
measure: Percentage of Participants Reporting Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group)
measure: Percentage of Participants Reporting Potential Immune-mediated Disease (pIMDs)
timeFrame: From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Tempe
country: United States
facility: GSK Investigational Site
state: Arizona
city: Canoga Park
country: United States
facility: GSK Investigational Site
state: California
city: Colton
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: Aurora
country: United States
facility: GSK Investigational Site
state: Colorado
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: Hialeah
country: United States
facility: GSK Investigational Site
state: Florida
city: Immokalee
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Sandy Springs
country: United States
facility: GSK Investigational Site
state: Georgia
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Mishawaka
country: United States
facility: GSK Investigational Site
state: Indiana
city: Valparaiso
country: United States
facility: GSK Investigational Site
state: Indiana
city: Ames
country: United States
facility: GSK Investigational Site
state: Iowa
city: El Dorado
country: United States
facility: GSK Investigational Site
state: Kansas
city: Methuen
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Grand Island
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Papillion
country: United States
facility: GSK Investigational Site
state: Nebraska
city: North Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Warren
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Hickory
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Rocky Mount
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Edmond
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: North Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Jefferson City
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
References:
citation: Buynak R, Cannon K, DeAtkine D, Kirby J, Usdan L, Bhavsar A, Gerard C, Kuznetsova A, Jayadev A, Amare H, Valenciano S, Meyer N. Randomized, Open-Label Phase 3 Study Evaluating Immunogenicity, Safety, and Reactogenicity of RSVPreF3 OA Coadministered with FLU-QIV-HD in Adults Aged >/= 65. Infect Dis Ther. 2024 Aug;13(8):1789-1805. doi: 10.1007/s40121-024-00985-4. Epub 2024 Jun 26.