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

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05568797
• Other study ID #: 218350
• Secondary ID: 2022-000623-21
• Status: Completed
• Phase: Phase 3
• Start date: October 14, 2022
• Est. completion date: July 17, 2023

Study information

• Verified date: February 2024
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1045
• Est. completion date: July 17, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human
• Respiratory Syncytial Virus Infections

Intervention

Biological:
• RSVPreF3 OA vaccine
One dose of RSVPreF3 OA vaccine administered intramuscularly.
• FLU vaccine
One dose of FLU vaccine administered intramuscularly.

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Erpent
Belgium	GSK Investigational Site	Genk
Belgium	GSK Investigational Site	Ieper
Finland	GSK Investigational Site	Espoo
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Kokkola
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Seinajoki
Finland	GSK Investigational Site	Tampere
France	GSK Investigational Site	Angers
France	GSK Investigational Site	Clermont-Ferrand Cedex 1
France	GSK Investigational Site	Limoges Cedex
France	GSK Investigational Site	Lyon cedex 04
France	GSK Investigational Site	Montpellier cedex 5
France	GSK Investigational Site	Nîmes cedex 9
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Pierre-Bénite
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	Marbella - Málaga	Andalucia
Spain	GSK Investigational Site	Salamanca
Spain	GSK Investigational Site	Santander (Cantabria)
Spain	GSK Investigational Site	Valladolid
Spain	GSK Investigational Site	Vic
United Kingdom	GSK Investigational Site	Blackpool
United Kingdom	GSK Investigational Site	Bollington	Cheshire
United Kingdom	GSK Investigational Site	Bristol
United Kingdom	GSK Investigational Site	Chippenham
United Kingdom	GSK Investigational Site	Chippenham	Wiltshire
United Kingdom	GSK Investigational Site	Peterborough
United Kingdom	GSK Investigational Site	Soham	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Finland,  France,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains	SCR for HI antibody is defined as the percentage of participants who have either a HI predose titer less than (<) 1:10 and a post-dose titer greater than or equal to (>=) 1:40, or a pre-dose titer >= 1:10 and at least a 4-fold increase in post-dose titer. The assessed Flu strains were: 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.	At 1 month after the FLU vaccine dose (Day 31 for both groups)
Secondary	RSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI)	MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.	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)
Secondary	RSV-B Neutralization Antibody Titers Expressed as MGI	MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.	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)
Secondary	Titers for HI Antibodies Against 4 FLU Vaccine Strains	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. HI antibodies were expressed as GMT, in titers.	At Day 1 (Baseline) and Day 31
Secondary	HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains	SPR for HI antibody was defined as the percentage of participants with a serum HI titer >= 1:40. The assessed Flu strains were: 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.	At Day 1 (Baseline) and Day 31
Secondary	HI Antibody Titers for 4 FLU Vaccine Strains Expressed as MGI	MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. The assessed Flu strains were: 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.	At 1 month after the FLU dose (Day 31 for both groups) compared to pre-vaccination (Day 1 for both groups)
Secondary	Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration	The solicited administration site events after vaccination include erythema, pain and swelling.	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)
Secondary	Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration	The solicited systemic events after vaccination include fever, headache, fatigue, myalgia and arthralgia.	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)
Secondary	Percentage of Participants Reporting Unsolicited Adverse Events (AEs)	An unsolicited AEs is an AE that is not included in a list of solicited events using a Participant Electronic Diary. Unsolicited events must be spontaneously communicated by a participant who signs the informed consent. Unsolicited AEs include both serious, non-serious AEs and potential immune-mediated diseases (pIMDs).	Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration
Secondary	Percentage of Participants Reporting at Least One Serious Adverse Event (SAEs)	An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant.	From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group)
Secondary	Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMDs)	pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. The investigator must exercise his/her medical/scientific judgment to determine whether other diseases have an autoimmune origin (i.e., pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD.	From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group)