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

NCT05568797 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2183502022-000623-21
• Study Type: interventional
• Target: 1,045
• Locations: 5 countries
• Sites: 37

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

Keywords

Respiratory syncytial virus; Adjuvanted quadrivalent influenza vaccine; Immunogenicity; Safety; Reactogenicity; Adults aged 65 years and above

Outcome Measures

Primary Outcomes (3)

• 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

  HI antibodies assessed were antibodies against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata flu strains.

  At 1 month after the FLU vaccine dose (Day 31 for both groups)

• RSV-A Neutralizing Antibody Titers Expressed as GMTs

  RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dilution 60 (ED60).

  At 1 month after the RSVPreF3 OA dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)

• RSV-B Neutralizing Antibody Titers Expressed as GMTs

  RSV B neutralizing antibodies are given as GMTs and expressed as Estimated Dilution 60 (ED60).

  At 1 month after the RSVPreF3 OA dose (Day 31 for the CoAd Group and Day 61 for the Control Group)

Secondary Outcomes (11)

• HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains

  At 1 month after the FLU vaccine dose (Day 31 for both groups)

• RSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI)

  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)

• RSV-B Neutralization Antibody Titers Expressed as MGI

  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)

• Titers for HI Antibodies Against 4 FLU Vaccine Strains

  At Day 1 (Baseline) and Day 31

• HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains

  At Day 1 (Baseline) and Day 31

Study Arms (2)

Co-Ad Group

EXPERIMENTAL

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.

Biological: RSVPreF3 OA vaccine; Biological: FLU vaccine

Control Group

ACTIVE COMPARATOR

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.

Biological: RSVPreF3 OA vaccine; Biological: FLU vaccine

Interventions

RSVPreF3 OA vaccine BIOLOGICAL

One dose of RSVPreF3 OA vaccine administered intramuscularly.

Co-Ad Group; Control Group

FLU vaccine BIOLOGICAL

One dose of FLU vaccine administered intramuscularly.

Also known as: Fluad Tetra, FLUAD QUADRIVALENT, Fluad Quad

Co-Ad Group; Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (37)

GSK Investigational Site

Edegem, 2650, Belgium

Location

GSK Investigational Site

Erpent, 5101, Belgium

Location

GSK Investigational Site

Genk, 3600, Belgium

Location

GSK Investigational Site

Ieper, 8900, Belgium

Location

GSK Investigational Site

Espoo, 02230, Finland

Location

GSK Investigational Site

Helsinki, 00100, Finland

Location

GSK Investigational Site

Kokkola, 67100, Finland

Location

GSK Investigational Site

Oulu, 90220, Finland

Location

GSK Investigational Site

Seinäjoki, 60100, Finland

Location

GSK Investigational Site

Tampere, 33100, Finland

Location

GSK Investigational Site

Angers, 49000, France

Location

GSK Investigational Site

Clermont-Ferrand, 63003, France

Location

GSK Investigational Site

Limoges, 87042, France

Location

GSK Investigational Site

Lyon, 69317, France

Location

GSK Investigational Site

Montpellier, 34295, France

Location

GSK Investigational Site

Nîmes, 30029, France

Location

GSK Investigational Site

Paris, 75679, France

Location

GSK Investigational Site

Pierre-Bénite, 69495, France

Location

GSK Investigational Site

Marbella - Málaga, Andalusia, 29603, Spain

Location

GSK Investigational Site

Benalmádena, Málaga, 29630, Spain

Location

GSK Investigational Site

Boadilla Del Monte (Madrid), 28660, Spain

Location

GSK Investigational Site

Burgos, 09006, Spain

Location

GSK Investigational Site

Centelles, 08540, Spain

Location

GSK Investigational Site

La Roca Del Valles (Barcelona), 08430, Spain

Location

GSK Investigational Site

Madrid, 28006, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Salamanca, 37007, Spain

Location

GSK Investigational Site

Santander (Cantabria), 39008, Spain

Location

GSK Investigational Site

Valladolid, 47005, Spain

Location

GSK Investigational Site

Vic, 28500, Spain

Location

GSK Investigational Site

Soham, Cambridgeshire, CB7 5JD, United Kingdom

Location

GSK Investigational Site

Bollington, Cheshire, SK10 5JH, United Kingdom

Location

GSK Investigational Site

Chippenham, Wiltshire, SN15 2SB, United Kingdom

Location

GSK Investigational Site

Blackpool, FY3 7EN, United Kingdom

Location

GSK Investigational Site

Bristol, BS37 4AX, United Kingdom

Location

GSK Investigational Site

Chippenham, SN14 6GT, United Kingdom

Location

GSK Investigational Site

Peterborough, PE8 6PL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39099085 BACKGROUND

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: October 14, 2022
• Primary Completion: February 17, 2023
• Study Completion: July 17, 2023
• Last Updated: September 24, 2024
• Results First Posted: March 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

BE (4); FR (8); ES (12); FI (6); GB (7)