Clinical trial NCT05568797: A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone or Co-administered With an Adjuvanted Vaccine Against Influenza in Adults Aged 65 Years and Above
Official title: A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of an RSVPreF3 OA Investigational Vaccine When Co-administered With FLU aQIV (Inactivated Influenza Vaccine - Adjuvanted) in Adults Aged 65 Years and Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory syncytial virus
Adjuvanted quadrivalent influenza vaccine
Immunogenicity
Safety
Reactogenicity
Adults aged 65 years and above
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2022-10-06
Enrollment: 1045
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 aim of this study is to assess the immunogenicity, safety and reactogenicity of the RSV PreFusion protein 3 older adult (RSVPreF3 OA) investigational vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU aQIV) vaccine, in adults aged 65 years of age (YOA).


Eligibility criteria: Inclusion Criteria:

* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the electronic diary cards \[eDiaries\], return for follow-up visits, ability to access and utilize a phone or other electronic communications).
* A male or female ≥ 65 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 study intervention administration. Participants 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 (no laboratory testing required).
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, in particular any history of severe allergic reaction to egg protein or to a previous influenza vaccine.
* Hypersensitivity to latex.
* Guillain-Barré syndrome that occurred within 6 weeks of receipt of prior influenza vaccine.
* 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.

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 interventions, 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. In the case of COVID-19 vaccines, this time window can be decreased to 14 days before and after each study intervention administration provided this COVID-19 vaccine use is in line with local governmental recommendations.
* 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 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.

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 (drug or 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.
* Bedridden participants.
* Planned move during the study conduct that prohibits participation until study end.
* Participation of any study personnel or their immediate dependents, family, or household members.

Primary outcomes:
measure: Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose
timeFrame: At 1 month after the FLU vaccine dose (Day 31 for both groups)
measure: RSV-A Neutralizing Antibody Titers Expressed as GMTs
timeFrame: At 1 month after the RSVPreF3 OA dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
measure: RSV-B Neutralizing Antibody Titers Expressed as GMTs
timeFrame: At 1 month after the RSVPreF3 OA dose (Day 31 for the CoAd 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 Neutralization Antibody 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 Neutralization Antibody 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: Titers for HI Antibodies Against 4 FLU Vaccine Strains
timeFrame: At Day 1 (Baseline) and Day 31
measure: HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
timeFrame: At Day 1 (Baseline) and Day 31
measure: HI Antibody Titers for 4 FLU Vaccine Strains Expressed as MGI
timeFrame: At 1 month after the FLU dose (Day 31 for both groups) compared to pre-vaccination (Day 1 for both groups)
measure: Percentage of Participants Reporting Each Solicited Administration Site Event 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 CoAd Group and at Day 1 and Day 31 for Control group)
measure: Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration
timeFrame: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 and Day 31 for C-oAd Group and at Day 1 and Day 31 for Control group)
measure: Percentage of Participants Reporting Unsolicited Adverse Events (AEs)
timeFrame: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration
measure: Percentage of Participants Reporting at Least One Serious Adverse Event (SAEs)
timeFrame: From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group)
measure: Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMDs)
timeFrame: From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: GSK Investigational Site
city: Erpent
country: Belgium
facility: GSK Investigational Site
city: Genk
country: Belgium
facility: GSK Investigational Site
city: Ieper
country: Belgium
facility: GSK Investigational Site
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Kokkola
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Angers
country: France
facility: GSK Investigational Site
city: Clermont-Ferrand Cedex 1
country: France
facility: GSK Investigational Site
city: Limoges Cedex
country: France
facility: GSK Investigational Site
city: Lyon cedex 04
country: France
facility: GSK Investigational Site
city: Montpellier cedex 5
country: France
facility: GSK Investigational Site
city: Nîmes cedex 9
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Pierre-Bénite
country: France
facility: GSK Investigational Site
city: Marbella - Málaga
country: Spain
facility: GSK Investigational Site
state: Andalucia
city: Benalmádena, Málaga
country: Spain
facility: GSK Investigational Site
city: Boadilla Del Monte (Madrid)
country: Spain
facility: GSK Investigational Site
city: Burgos
country: Spain
facility: GSK Investigational Site
city: Centelles
country: Spain
facility: GSK Investigational Site
city: La Roca Del Valles (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Salamanca
country: Spain
facility: GSK Investigational Site
city: Santander (Cantabria)
country: Spain
facility: GSK Investigational Site
city: Valladolid
country: Spain
facility: GSK Investigational Site
city: Vic
country: Spain
facility: GSK Investigational Site
city: Soham
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
city: Bollington
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Chippenham
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Blackpool
country: United Kingdom
facility: GSK Investigational Site
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
city: Chippenham
country: United Kingdom
facility: GSK Investigational Site
city: Peterborough
country: United Kingdom
facility: GSK Investigational Site
Study officials:
References:
citation: Clark R, Davies S, Labrador J, Loubet P, Natalini Martinez S, Morinigo HM, Nicolas JF, Vera MP, Ramet M, Rebollo-Rodrigo MH, Sanz-Munoz I, Dezutter N, Germain S, David MP, Jayadev A, Amare Hailemariam H, Kotb S, Meyer N. Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion F Protein Vaccine when Co-administered with Adjuvanted Seasonal Quadrivalent Influenza Vaccine in Older Adults: A Phase 3 Randomized Trial. Clin Infect Dis. 2024 Oct 15;79(4):1088-1098. doi: 10.1093/cid/ciae365.