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

GlaxoSmithKline1 site in 1 country976 target enrollmentApril 27, 2021

ConditionsRespiratory Syncytial Virus Infections

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Respiratory Syncytial Virus Infections
Sponsor: GlaxoSmithKline
Enrollment: 976
Locations: 1
Primary Endpoint: Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 27, 2021

End Date

February 8, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs

Time Frame: 1 month after the FLU vaccine dose (at Day 31)

HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/Dilution (DIL) where DIL corresponds to the highest dilution that shows complete HI.

RSV-A Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs)

Time Frame: 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)

The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-A entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum.

Secondary Outcomes

Secondary: HI Seroconversion Status for Each of the Flu Vaccine Strains Expressed as Seroconversion Rate (SCR)(1 month after the FLU vaccine dose (at Day 31))
RSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI)(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))
Percentage of Participants With Solicited Administration Site Events(Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination)
RSV-B Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMT)(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))
RSV-B Neutralization Antibody Titers Expressed as MGI(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))
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs(At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31))
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as MGI(1 month after the FLU vaccine dose (at Day 31))
Percentage of Participants With Solicited Systemic Events(Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination)
Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD)(From Day 1 up to study end (6 months after last vaccination))
HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR)(At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31))
Percentage of Participants Reporting at Least One Serious Adverse Event (SAE)(From Day 1 up to study end (6 months after last vaccination))
Percentage of Participants Reporting at Least One Unsolicited Adverse Event(Within 30 days (the day of vaccination and 29 subsequent days) after each vaccination)