A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

A Phase 3, Open-label, Randomized, Controlled, Multicountry Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU HD Vaccine in Adults Aged 65 Years and Above

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05559476
• Other study ID #: 214489
• Secondary ID: 2021-001356-34
• Status: Completed
• Phase: Phase 3
• Start date: October 20, 2022
• Est. completion date: August 15, 2023

Study information

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

Clinical Trial 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 high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1029
• Est. completion date: August 15, 2023
• Est. primary completion date: March 7, 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

• A male or female =65 years of age 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 (no laboratory testing required).

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.

• Hypersensitivity to latex.

• History of Guillain Barré syndrome, or anaphylaxis.

• 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.

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 study vaccine administration, 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.

Note: In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is recommended and/or organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.

• 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 first dose of study vaccine 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 vaccination 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 intervention (drug/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.

• Planned move during the study conduct that prohibits participation until 1 month post-last vaccine administration.

• Bedridden participants.

• Participation of any study personnel or their immediate dependents, family, or household members.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

Biological:
• RSVPreF3 OA investigational vaccine
RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
• FLU HD vaccine
FLU HD vaccine administered intramuscularly in the deltoid region of the dominant arm (Co-Ad Group) or the non-dominant arm (Control Group).

Locations

Country	Name	City	State
United States	GSK Investigational Site	Ames	Iowa
United States	GSK Investigational Site	Aurora	Colorado
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Canoga Park	California
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Colton	California
United States	GSK Investigational Site	Coral Gables	Florida
United States	GSK Investigational Site	Edmond	Oklahoma
United States	GSK Investigational Site	El Dorado	Kansas
United States	GSK Investigational Site	Elkridge	Maryland
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fort Myers	Florida
United States	GSK Investigational Site	Grand Island	Nebraska
United States	GSK Investigational Site	Hialeah	Florida
United States	GSK Investigational Site	Hickory	North Carolina
United States	GSK Investigational Site	Immokalee	Florida
United States	GSK Investigational Site	Jefferson City	Tennessee
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Methuen	Massachusetts
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Mishawaka	Indiana
United States	GSK Investigational Site	North Charleston	South Carolina
United States	GSK Investigational Site	North Las Vegas	Nevada
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Papillion	Nebraska
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Rocky Mount	North Carolina
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Sandy Springs	Georgia
United States	GSK Investigational Site	Savannah	Georgia
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Tempe	Arizona
United States	GSK Investigational Site	Valparaiso	Indiana
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	Warren	New Jersey
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)	RSV-A neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).	At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
Primary	Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs	HI titers were assessed 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 strains.	At 1 month after the FLU vaccine dose (Day 31 for both groups)
Primary	RSV-B Neutralizing Titers Expressed as Group GMTs	RSV-B neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).	At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
Secondary	HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains	SCR for HI titers was 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 Neutralizing 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 Neutralizing 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	HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT	HI titers were assessed 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 strains. HI antibodies were expressed as GMTs, in titers.	At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups)
Secondary	HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains	SPR for HI titers was defined as the percentage of participants with a serum HI titer >= 1:40. The assessed Flu strains were: 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 and 1 month after FLU vaccine dose administration (Day 31 for both groups)
Secondary	HI 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.	At 1 month after the FLU vaccine dose administration (Day 31 for both groups)
Secondary	Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration	The solicited administration site events after vaccination included erythema, pain and swelling.	Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)
Secondary	Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration	The solicited systemic events after vaccination include arthralgia, fatigue, fever, headache and myalgia.	Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)
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 diary. Unsolicited events must have been 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 after vaccine administration (the day of vaccination and 29 subsequent days after vaccination)
Secondary	Percentage of Participants Reporting Serious Adverse Events (SAEs)	An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.	From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group)
Secondary	Percentage of Participants Reporting 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 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group)