A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above

NCT05059301 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2171312021-002225-18
• Study Type: interventional
• Target: 770
• Locations: 3 countries
• Sites: 19

Brief Summary

The purpose of this study is to assess the lot-to-lot consistency in terms of immunogenicity and evaluate the safety and reactogenicity of 3 lots of the RSVPreF3 OA investigational vaccine administered as a single dose in adults ≥ 60 years of age (YOA).

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory syncytial virus; Adults aged 60 years and above; Lot-to-lot consistency; Safety; Reactogenicity

Outcome Measures

Primary Outcomes (1)

• RSVPreF3 Specific Immunoglobin (Ig)G Antibody Concentrations Expressed as Group Geometric Mean Concentration (GMC)

  Enzyme-linked immunosorbent assay (ELISA) was used to assess the concentrations of IgG antibodies against RSV PreF3 in serum samples.

  At 30 days post-vaccination (Day 31)

Secondary Outcomes (6)

• RSVPreF3 Specific IgG Antibody Concentrations Expressed as Mean Geometric Increase (MGI)

  At 30 days post-vaccination (Day 31)

• Percentage of Participants Reporting Solicited Administration Site Events

  Within 4 days (the day of vaccination and 3 subsequent days) after study intervention administration

• Percentage of Participants Reporting Solicited Systemic Events

  Within 4 days (the day of vaccination and 3 subsequent days) after study intervention administration

• Percentage of Participants Reporting at Least One Unsolicited Adverse Event

  Within 30 days (the day of vaccination and 29 subsequent days) after study intervention administration

• Percentage of Participants Reporting at Least One Serious Adverse Event (SAE)

  From Day 1 up to study end (6 months after vaccination)

Study Arms (3)

RSV OA_Lot 1

EXPERIMENTAL

Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).

Biological: RSVPreF3 OA investigational vaccine

RSV OA_Lot 2

EXPERIMENTAL

Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).

Biological: RSVPreF3 OA investigational vaccine

RSV OA_Lot 3

EXPERIMENTAL

Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).

Biological: RSVPreF3 OA investigational vaccine

Interventions

RSVPreF3 OA investigational vaccine BIOLOGICAL

One dose of a unique combination of the RSVPreF3 antigen lots (Lot 1, Lot 2 or Lot 3) and extemporaneously reconstituted with AS01E adjuvant lots (Lot A, Lot B and Lot C), administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1.

RSV OA_Lot 1; RSV OA_Lot 2; RSV OA_Lot 3

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 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 vaccination. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, can 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 study intervention(s).
• Hypersensitivity to latex.
• 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.
• 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 intervention(s) during the period beginning 30 days before study intervention administration and ending 30 days after study intervention administration, or planned use during the study period.
• Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the study intervention administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after the study vaccination.
• 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 administration of the study intervention or planned administration during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (19)

GSK Investigational Site

Waterbury, Connecticut, 06708, United States

Location

GSK Investigational Site

Brooksville, Florida, 34613, United States

Location

GSK Investigational Site

Immokalee, Florida, 34142, United States

Location

GSK Investigational Site

Buford, Georgia, 30519, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55402, United States

Location

GSK Investigational Site

Petal, Mississippi, 39465, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68144, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27408, United States

Location

GSK Investigational Site

Houston, Texas, 77058, United States

Location

GSK Investigational Site

Vancouver, British Columbia, V5Z 1K3, Canada

Location

GSK Investigational Site

Moncton, New Brunswick, E1G1A7, Canada

Location

GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada

Location

GSK Investigational Site

Toronto, Ontario, M3J 2C5, Canada

Location

GSK Investigational Site

Québec, Quebec, G1W 4R4, Canada

Location

GSK Investigational Site

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1J 2G2, Canada

Location

GSK Investigational Site

Eskilstuna, SE-631 88, Sweden

Location

GSK Investigational Site

Karlskrona, SE-371 79, Sweden

Location

GSK Investigational Site

Uppsala, SE-752 37, Sweden

Location

Related Publications (1)

• Ferguson M, Murray A, Pliamm L, Rombo L, Sanmartin Berglund J, David MP, De Schrevel N, Maschino F, Kotb S, Olivier A, Hulstrom V. Lot-to-lot immunogenicity consistency of the respiratory syncytial virus prefusion F protein vaccine in older adults. Vaccine X. 2024 Apr 27;18:100494. doi: 10.1016/j.jvacx.2024.100494. eCollection 2024 Jun.

  PMID: 38746060 DERIVED

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Study is double blind from start to final analysis after which the study is considered single blind.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: October 1, 2021
• Primary Completion: January 24, 2022
• Study Completion: June 30, 2022
• Last Updated: February 15, 2023
• Results First Posted: February 15, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (9); CA (7); SE (3)