Clinical trial NCT04841577: 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 60 Years and Above
Official title: A Phase 3, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU-QIV Vaccine in Adults Aged 60 Years and Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-04-12
Enrollment: 976
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 immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the seasonal quadrivalent influenza vaccine (FLU-QIV) in adults aged 60 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 ≥60 YOA 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.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Hypersensitivity to latex.
* History of GBS, anaphylaxis, febrile seizures, Bell's palsy and narcolepsy.
* 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 dose of study vaccines and ending 30 days after the last vaccine administration, or planned use during the study period.
* Administration of an influenza vaccine during the 6 months preceding the study FLU-QIV 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 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 Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs)
timeFrame: At 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
measure: Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs
timeFrame: 1 month after the FLU vaccine dose (at Day 31)
Secondary outcomes:
measure: Secondary: HI Seroconversion Status for Each of the Flu Vaccine Strains Expressed as Seroconversion Rate (SCR)
timeFrame: 1 month after the FLU vaccine dose (at Day 31)
measure: RSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI)
timeFrame: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
measure: RSV-B Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMT)
timeFrame: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
measure: RSV-B Neutralization Antibody Titers Expressed as MGI
timeFrame: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
measure: HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs
timeFrame: At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31)
measure: HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR)
timeFrame: At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31)
measure: HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as MGI
timeFrame: 1 month after the FLU vaccine dose (at Day 31)
measure: Percentage of Participants With Solicited Administration Site Events
timeFrame: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination
measure: Percentage of Participants With Solicited Systemic Events
timeFrame: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination
measure: Percentage of Participants Reporting at Least One Unsolicited Adverse Event
timeFrame: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccination
measure: Percentage of Participants Reporting at Least One Serious Adverse Event (SAE)
timeFrame: From Day 1 up to study end (6 months after last vaccination)
measure: Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD)
timeFrame: From Day 1 up to study end (6 months after last vaccination)
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Havelock North
country: New Zealand
facility: GSK Investigational Site
city: Paraparaumu
country: New Zealand
facility: GSK Investigational Site
city: Tauranga
country: New Zealand
facility: GSK Investigational Site
city: Wellington
country: New Zealand
facility: GSK Investigational Site
city: Ciudad de Panama
country: Panama
facility: GSK Investigational Site
city: Panama
country: Panama
facility: GSK Investigational Site
city: Panama
country: Panama
facility: GSK Investigational Site
city: Panama
country: Panama
facility: GSK Investigational Site
city: Panama
country: Panama
facility: GSK Investigational Site
city: Boksburg
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Middelburg
country: South Africa
facility: GSK Investigational Site
state: Mpumalanga
Study officials:
References:
citation: Chandler R, Montenegro N, Llorach C, Aguirre LN, Germain S, Kuriyakose SO, Lambert A, Descamps D, Olivier A, Hulstrom V. Immunogenicity, Reactogenicity, and Safety of AS01E-adjuvanted RSV Prefusion F Protein-based Candidate Vaccine (RSVPreF3 OA) When Co-administered With a Seasonal Quadrivalent Influenza Vaccine in Older Adults: Results of a Phase 3, Open-Label, Randomized Controlled Trial. Clin Infect Dis. 2024 Jan 8:ciad786. doi: 10.1093/cid/ciad786. Online ahead of print.