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

NCT05559476 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2144892021-001356-34
• Study Type: interventional
• Target: 1,029
• Locations: 1 country
• Sites: 46

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.

Conditions

Respiratory Syncytial Virus Infections

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (11)

• HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains

  At 1 month after the FLU vaccine dose (Day 31 for both groups)

• RSV-A Neutralizing Titers Expressed as Mean Geometric Increase (MGI)

  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)

• RSV-B Neutralizing Titers Expressed as MGI

  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)

• HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT

  At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups)

• HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains

  At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups)

Study Arms (2)

Co-Ad Group

EXPERIMENTAL

Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.

Biological: RSVPreF3 OA investigational vaccine; Biological: FLU HD vaccine

Control Group

ACTIVE COMPARATOR

Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.

Biological: RSVPreF3 OA investigational vaccine; Biological: FLU HD vaccine

Interventions

RSVPreF3 OA investigational vaccine BIOLOGICAL

RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Co-Ad Group; Control Group

FLU HD vaccine BIOLOGICAL

FLU HD vaccine administered intramuscularly in the deltoid region of the dominant arm (Co-Ad Group) or the non-dominant arm (Control Group).

Co-Ad Group; Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (46)

GSK Investigational Site

Birmingham, Alabama, 35205, United States

Location

GSK Investigational Site

Tempe, Arizona, 85281, United States

Location

GSK Investigational Site

Canoga Park, California, 91303, United States

Location

GSK Investigational Site

Colton, California, 92324, United States

Location

GSK Investigational Site

Sacramento, California, 95864, United States

Location

GSK Investigational Site

San Diego, California, 92103-6204, United States

Location

GSK Investigational Site

Walnut Creek, California, 94598, United States

Location

GSK Investigational Site

Aurora, Colorado, 80012, United States

Location

GSK Investigational Site

Coral Gables, Florida, 33134, United States

Location

GSK Investigational Site

Fort Myers, Florida, 33912, United States

Location

GSK Investigational Site

Hialeah, Florida, 33012, United States

Location

GSK Investigational Site

Immokalee, Florida, 34142, United States

Location

GSK Investigational Site

Miami, Florida, 33016, United States

Location

GSK Investigational Site

Miami, Florida, 33184, United States

Location

GSK Investigational Site

Orlando, Florida, 32801, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33409, United States

Location

GSK Investigational Site

Sandy Springs, Georgia, 30328, United States

Location

GSK Investigational Site

Savannah, Georgia, 31406, United States

Location

GSK Investigational Site

Chicago, Illinois, 60640, United States

Location

GSK Investigational Site

Evansville, Indiana, 47714, United States

Location

GSK Investigational Site

Mishawaka, Indiana, 46544, United States

Location

GSK Investigational Site

Valparaiso, Indiana, 46383, United States

Location

GSK Investigational Site

Ames, Iowa, 50010, United States

Location

GSK Investigational Site

El Dorado, Kansas, 67042, United States

Location

GSK Investigational Site

Methuen, Massachusetts, 01844, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55402, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

Location

GSK Investigational Site

Grand Island, Nebraska, 68803, United States

Location

GSK Investigational Site

Papillion, Nebraska, 68046, United States

Location

GSK Investigational Site

North Las Vegas, Nevada, 89030, United States

Location

GSK Investigational Site

Warren Township, New Jersey, 07059, United States

Location

GSK Investigational Site

Hickory, North Carolina, 28601, United States

Location

GSK Investigational Site

Rocky Mount, North Carolina, 27804, United States

Location

GSK Investigational Site

Wilmington, North Carolina, 28401, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45236, United States

Location

GSK Investigational Site

Edmond, Oklahoma, 73013, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15243, United States

Location

GSK Investigational Site

Columbia, South Carolina, 21045, United States

Location

GSK Investigational Site

North Charleston, South Carolina, 29405, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Jefferson City, Tennessee, 37760, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38119, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37912, United States

Location

GSK Investigational Site

Austin, Texas, 78745, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

San Antonio, Texas, 78237, United States

Location

Related Publications (1)

• Buynak R, Cannon K, DeAtkine D, Kirby J, Usdan L, Bhavsar A, Gerard C, Kuznetsova A, Jayadev A, Amare H, Valenciano S, Meyer N. Randomized, Open-Label Phase 3 Study Evaluating Immunogenicity, Safety, and Reactogenicity of RSVPreF3 OA Coadministered with FLU-QIV-HD in Adults Aged >/= 65. Infect Dis Ther. 2024 Aug;13(8):1789-1805. doi: 10.1007/s40121-024-00985-4. Epub 2024 Jun 26.

  PMID: 38981954 BACKGROUND

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: October 20, 2022
• Primary Completion: March 7, 2023
• Study Completion: August 15, 2023
• Last Updated: September 24, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.

Locations

US (46)