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 60 Years and Above

NCT04841577 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 214488
• Study Type: interventional
• Target: 976
• Locations: 3 countries
• Sites: 14

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.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (2)

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

  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.

  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)

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

  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.

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

Secondary Outcomes (12)

• 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)

• 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)

Study Arms (2)

Co-Ad Group

EXPERIMENTAL

Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.

Biological: RSVPreF3 OA investigational vaccine; Biological: FLU-QIV

Control Group

ACTIVE COMPARATOR

Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.

Biological: RSVPreF3 OA investigational vaccine; Biological: FLU-QIV

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-QIV BIOLOGICAL

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

Co-Ad Group; Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), 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 ≥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.

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.
• 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.
• 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 dose of study vaccines and ending 30 days after the last vaccine administration, or planned use during the study period.
• Administration of an influenza vaccine during the 6 months preceding the study FLU-QIV 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 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 (14)

GSK Investigational Site

Auckland, 1010, New Zealand

Location

GSK Investigational Site

Auckland, 1701, New Zealand

Location

GSK Investigational Site

Christchurch, 8011, New Zealand

Location

GSK Investigational Site

Havelock North, 4130, New Zealand

Location

GSK Investigational Site

Paraparaumu, 5032, New Zealand

Location

GSK Investigational Site

Tauranga, 3001, New Zealand

Location

GSK Investigational Site

Wellington, 6242, New Zealand

Location

GSK Investigational Site

Panama City, 0801, Panama

Location

GSK Investigational Site

Panama City, 1001, Panama

Location

GSK Investigational Site

Panama City, 7002, Panama

Location

GSK Investigational Site

Panama City, 7099, Panama

Location

GSK Investigational Site

Panama City, 7219, Panama

Location

GSK Investigational Site

Boksburg, Gauteng, 1459, South Africa

Location

GSK Investigational Site

Middelburg, Mpumalanga, 1055, South Africa

Location

Related Publications (1)

• Chandler R, Montenegro N, Llorach C, Aguirre LN, Germain S, Kuriyakose SO, Lambert A, Descamps D, Olivier A, Hulstrom V. Immunogenicity, Reactogenicity, and Safety of AS01E-adjuvanted RSV Prefusion F Protein-based Candidate Vaccine (RSVPreF3 OA) When Co-administered With a Seasonal Quadrivalent Influenza Vaccine in Older Adults: Results of a Phase 3, Open-Label, Randomized Controlled Trial. Clin Infect Dis. 2024 Jan 8:ciad786. doi: 10.1093/cid/ciad786. Online ahead of print.

  PMID: 38189778 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: April 8, 2021
• First Posted: April 12, 2021
• Study Start: April 27, 2021
• Primary Completion: September 22, 2021
• Study Completion: February 8, 2022
• Last Updated: September 3, 2024
• Results First Posted: October 18, 2022

Record last verified: 2024-08

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

NZ (7); PA (5); ZA (2)