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

NCT ID: NCT05568797

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1045 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-14
• Study Completion Date: 2023-07-17

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).

Conditions

Respiratory Syncytial Virus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Co-Ad Group

Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.

Group Type: EXPERIMENTAL

RSVPreF3 OA vaccine

Intervention Type: BIOLOGICAL

One dose of RSVPreF3 OA vaccine administered intramuscularly.

FLU vaccine

Intervention Type: BIOLOGICAL

One dose of FLU vaccine administered intramuscularly.

Control Group

Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.

Group Type: ACTIVE_COMPARATOR

RSVPreF3 OA vaccine

Intervention Type: BIOLOGICAL

One dose of RSVPreF3 OA vaccine administered intramuscularly.

FLU vaccine

Intervention Type: BIOLOGICAL

One dose of FLU vaccine administered intramuscularly.

Interventions

RSVPreF3 OA vaccine

One dose of RSVPreF3 OA vaccine administered intramuscularly.

Intervention Type: BIOLOGICAL

FLU vaccine

One dose of FLU vaccine administered intramuscularly.

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluad Tetra, FLUAD QUADRIVALENT, Fluad Quad

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Edegem, , Belgium

GSK Investigational Site

Erpent, , Belgium

GSK Investigational Site

Genk, , Belgium

GSK Investigational Site

Ieper, , Belgium

GSK Investigational Site

Espoo, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Kokkola, , Finland

GSK Investigational Site

Oulu, , Finland

GSK Investigational Site

Seinäjoki, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Angers, , France

GSK Investigational Site

Clermont-Ferrand, , France

GSK Investigational Site

Limoges, , France

GSK Investigational Site

Lyon, , France

GSK Investigational Site

Montpellier, , France

GSK Investigational Site

Nîmes, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Pierre-Bénite, , France

GSK Investigational Site

Marbella - Málaga, Andalusia, Spain

GSK Investigational Site

Benalmádena, Málaga, , Spain

GSK Investigational Site

Boadilla Del Monte (Madrid), , Spain

GSK Investigational Site

Burgos, , Spain

GSK Investigational Site

Centelles, , Spain

GSK Investigational Site

La Roca Del Valles (Barcelona), , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Salamanca, , Spain

GSK Investigational Site

Santander (Cantabria), , Spain

GSK Investigational Site

Valladolid, , Spain

GSK Investigational Site

Vic, , Spain

GSK Investigational Site

Soham, Cambridgeshire, United Kingdom

GSK Investigational Site

Bollington, Cheshire, United Kingdom

GSK Investigational Site

Chippenham, Wiltshire, United Kingdom

GSK Investigational Site

Blackpool, , United Kingdom

GSK Investigational Site

Bristol, , United Kingdom

GSK Investigational Site

Chippenham, , United Kingdom

GSK Investigational Site

Peterborough, , United Kingdom

Countries

Belgium; Finland; France; Spain; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 39099085 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2022-000623-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

218350

Identifier Type: -

Identifier Source: org_study_id