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

NCT ID: NCT05059301

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 770 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

RSV OA_Lot 1

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).

Group Type: EXPERIMENTAL

RSVPreF3 OA investigational vaccine

Intervention Type: 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 2

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).

Group Type: EXPERIMENTAL

RSVPreF3 OA investigational vaccine

Intervention Type: 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 3

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).

Group Type: EXPERIMENTAL

RSVPreF3 OA investigational vaccine

Intervention Type: 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.

Interventions

RSVPreF3 OA investigational vaccine

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.

Intervention Type: BIOLOGICAL

Eligibility 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 ≥ 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.

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 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.
• 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 study intervention administration 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 vaccine/product (drug or 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 period that will prohibit participating in the study until study end.
• Bedridden participants.
• Participation of any study personnel or their immediate dependents, family, or household members.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Waterbury, Connecticut, United States

GSK Investigational Site

Brooksville, Florida, United States

GSK Investigational Site

Immokalee, Florida, United States

GSK Investigational Site

Buford, Georgia, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

Petal, Mississippi, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Greensboro, North Carolina, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Vancouver, British Columbia, Canada

GSK Investigational Site

Moncton, New Brunswick, Canada

GSK Investigational Site

Truro, Nova Scotia, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Saint-Charles-Borromée, Quebec, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

GSK Investigational Site

Eskilstuna, , Sweden

GSK Investigational Site

Karlskrona, , Sweden

GSK Investigational Site

Uppsala, , Sweden

Countries

United States; Canada; Sweden

References

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.

Reference Type: DERIVED

PMID: 38746060 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-002225-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

217131

Identifier Type: -

Identifier Source: org_study_id