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.

• ClinicalTrials.gov Identifier: NCT05559476
• Recruitment Status: Active, not recruiting
• First Posted: September 29, 2022
• Last Update Posted: January 13, 2023
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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

Condition or disease	Intervention/treatment	Phase
Respiratory Syncytial Virus Infections	Biological: RSVPreF3 OA investigational vaccine; Biological: FLU HD vaccine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1028 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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.
• Actual Study Start Date: October 20, 2022
• Estimated Primary Completion Date: February 28, 2023
• Estimated Study Completion Date: August 11, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Co-Ad Group; Participants randomized to Co-Ad Group receive 1 dose of RSVPreF3 OA investigational vaccine and 1 dose of FLU HD at Day 1 and are followed up until the study end.	Biological: RSVPreF3 OA investigational vaccine; RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.; Biological: 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).
Active Comparator: Control Group; Participants randomized to Control Group receive 1 dose of FLU HD at Day 1, followed by 1 dose of RSVPreF3 OA investigational vaccine at Day 31 and are followed up until the study end.	Biological: RSVPreF3 OA investigational vaccine; RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.; Biological: 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).

Outcome Measures

Primary Outcome Measures :

1. RSV-A neutralization antibody titers expressed as group geometric mean titer (GMT) ratio [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine dose ]
2. Hemagglutinin inhibition (HI) antibody titers for each of the FLU vaccine strains, expressed as group GMT ratio [ Time Frame: 1 month after the FLU vaccine dose ]

Secondary Outcome Measures :

1. HI seroconversion rate (SCR) for each of the FLU vaccine strains [ Time Frame: 1 month after the FLU vaccine dose ]
2. RSV-A neutralization antibody titers expressed as mean geometric increase (MGI) [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine dose ]
3. RSV-B neutralization antibody titers expressed as group GMT ratio [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine dose ]
4. RSV-B neutralization antibody titers expressed as MGI [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine dose ]
5. HI antibody titers for each of the FLU vaccine strains, expressed as GMT [ Time Frame: At Day 1 and 1 month after vaccination (Day 31) ]
6. HI seroprotection rate (SPR) for each of the FLU vaccine strains [ Time Frame: At Day 1 and 1 month after vaccination (Day 31) ]
7. HI antibody titers for each of the FLU vaccine strains, expressed as MGI [ Time Frame: 1 month after the FLU vaccine dose ]
8. Percentage of participants with solicited administration site events [ Time Frame: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31) ]
   The solicited administration site events after vaccination include pain, erythema/redness and swelling.
9. Percentage of participants with solicited systemic events [ Time Frame: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31) ]
   The solicited systemic events after vaccination include fever, headache, fatigue, myalgia and arthralgia.
10. Percentage of participants with unsolicited adverse events (AEs) (potential immune-mediated disease (pIMD), non-serious AE or serious AE) [ Time Frame: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccination ]
    An unsolicited AEs is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include both serious, non-serious AEs and pIMDs.
11. Percentage of participants with serious adverse events (SAEs) [ Time Frame: From Day 1 up to study end (6 months after last vaccination) ]
    A 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.
12. Percentage of participants with pIMDs [ Time Frame: From Day 1 up to study end (6 months after last vaccination) ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 ≥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.

Contacts and Locations

Locations

United States, Alabama

GSK Investigational Site

Birmingham, Alabama, United States, 35205

United States, Arizona

GSK Investigational Site

Tempe, Arizona, United States, 85281

United States, California

GSK Investigational Site

Canoga Park, California, United States, 91303

GSK Investigational Site

Colton, California, United States, 92324

GSK Investigational Site

Sacramento, California, United States, 95864

GSK Investigational Site

San Diego, California, United States, 92103-6204

GSK Investigational Site

Walnut Creek, California, United States, 94598

United States, Colorado

GSK Investigational Site

Aurora, Colorado, United States, 80012

United States, Florida

GSK Investigational Site

Coral Gables, Florida, United States, 33134

GSK Investigational Site

Fort Myers, Florida, United States, 33912

GSK Investigational Site

Hialeah, Florida, United States, 33012

GSK Investigational Site

Immokalee, Florida, United States, 34142

GSK Investigational Site

Miami, Florida, United States, 33016

GSK Investigational Site

Miami, Florida, United States, 33184

GSK Investigational Site

Orlando, Florida, United States, 32801

GSK Investigational Site

West Palm Beach, Florida, United States, 33409

United States, Georgia

GSK Investigational Site

Sandy Springs, Georgia, United States, 30328

GSK Investigational Site

Savannah, Georgia, United States, 31406

United States, Illinois

GSK Investigational Site

Chicago, Illinois, United States, 60640

United States, Indiana

GSK Investigational Site

Evansville, Indiana, United States, 47714

GSK Investigational Site

Mishawaka, Indiana, United States, 46544

GSK Investigational Site

Valparaiso, Indiana, United States, 46383

United States, Iowa

GSK Investigational Site

Ames, Iowa, United States, 50010

United States, Kansas

GSK Investigational Site

El Dorado, Kansas, United States, 67042

United States, Maryland

GSK Investigational Site

Elkridge, Maryland, United States, 21075

United States, Massachusetts

GSK Investigational Site

Methuen, Massachusetts, United States, 01844

United States, Minnesota

GSK Investigational Site

Minneapolis, Minnesota, United States, 55402

United States, Missouri

GSK Investigational Site

Saint Louis, Missouri, United States, 63141

United States, Nebraska

GSK Investigational Site

Grand Island, Nebraska, United States, 68803

GSK Investigational Site

Papillion, Nebraska, United States, 68046

United States, Nevada

GSK Investigational Site

North Las Vegas, Nevada, United States, 89030

United States, New Jersey

GSK Investigational Site

Warren, New Jersey, United States, 07059

United States, North Carolina

GSK Investigational Site

Fayetteville, North Carolina, United States, 28306

GSK Investigational Site

Hickory, North Carolina, United States, 28601

GSK Investigational Site

Rocky Mount, North Carolina, United States, 27804

GSK Investigational Site

Wilmington, North Carolina, United States, 28401

United States, Ohio

GSK Investigational Site

Cincinnati, Ohio, United States, 45236

United States, Oklahoma

GSK Investigational Site

Edmond, Oklahoma, United States, 73013

United States, Pennsylvania

GSK Investigational Site

Pittsburgh, Pennsylvania, United States, 15243

United States, South Carolina

GSK Investigational Site

North Charleston, South Carolina, United States, 29405

GSK Investigational Site

Spartanburg, South Carolina, United States, 29303

United States, Tennessee

GSK Investigational Site

Jefferson City, Tennessee, United States, 37760

GSK Investigational Site

Knoxville, Tennessee, United States, 37912

GSK Investigational Site

Memphis, Tennessee, United States, 38119

United States, Texas

GSK Investigational Site

Austin, Texas, United States, 78745

GSK Investigational Site

San Antonio, Texas, United States, 78229

GSK Investigational Site

San Antonio, Texas, United States, 78237

Sponsors and Collaborators

GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT05559476
• Other Study ID Numbers: 214489; 2021-001356-34 ( EudraCT Number )
• First Posted: September 29, 2022
• Last Update Posted: January 13, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by GlaxoSmithKline:

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

Additional relevant MeSH terms:

Respiratory Syncytial Virus Infections; Virus Diseases; Infections; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs