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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05559476
Recruitment Status : Active, not recruiting
First Posted : September 29, 2022
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

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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

Resource links provided by the National Library of Medicine


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).




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05559476


Locations
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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
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT05559476    
Other Study ID Numbers: 214489
2021-001356-34 ( EudraCT Number )
First Posted: September 29, 2022    Key Record Dates
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.

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