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Respiratory Syncytial Virus InfectionsPhase 3NCT05059301

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

A Phase 3 study testing RSVPreF3 OA investigational vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 19 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
RSVPreF3 OA investigational vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
770 participants
Where
19 sitesin 3 countries
Study dates
1 Oct 2021to 30 Jun 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.

Trial locations and contacts

19 sites in 3 countries.

19 sites in 3 countries

United States9 sites

  • GSK Investigational Site

    Brooksville, Florida, 34613

  • GSK Investigational Site

    Buford, Georgia, 30519

  • GSK Investigational Site

    Greensboro, North Carolina, 27408

  • GSK Investigational Site

    Houston, Texas, 77058

  • GSK Investigational Site

    Immokalee, Florida, 34142

  • GSK Investigational Site

    Minneapolis, Minnesota, 55402

  • GSK Investigational Site

    Omaha, Nebraska, 68144

  • GSK Investigational Site

    Petal, Mississippi, 39465

  • GSK Investigational Site

    Waterbury, Connecticut, 06708

Other trials in United States

Canada7 sites

  • GSK Investigational Site

    Moncton, New Brunswick, E1G1A7

  • GSK Investigational Site

    Québec, Quebec, G1W 4R4

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • GSK Investigational Site

    Sherbrooke, Quebec, J1J 2G2

  • GSK Investigational Site

    Toronto, Ontario, M3J 2C5

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1K3

Other trials in Canada

Sweden3 sites

  • GSK Investigational Site

    Eskilstuna, SE-631 88

  • GSK Investigational Site

    Karlskrona, SE-371 79

  • GSK Investigational Site

    Uppsala, SE-752 37

Other trials in Sweden

About this study

Official title: A Phase 3, Randomized, Double-blind, Multi-country Study to Evaluate Consistency, Safety, and Reactogenicity of 3 Lots of RSVPreF3 OA Investigational Vaccine Administrated as a Single Dose in Adults Aged 60 Years and Above

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).

Being tested
RSVPreF3 OA investigational vaccine
Keywords
Respiratory syncytial virus, Adults aged 60 years and above, Lot-to-lot consistency, Safety, Reactogenicity
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RSVPreF3 OA investigational vaccineBiological

    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.

Study groups in NCT05059301
Study groupRoleWhat they receive
RSV OA_Lot 1ExperimentalParticipants 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).
Receives: Biological: RSVPreF3 OA investigational vaccine
RSV OA_Lot 2ExperimentalParticipants 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).
Receives: Biological: RSVPreF3 OA investigational vaccine
RSV OA_Lot 3ExperimentalParticipants 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).
Receives: Biological: RSVPreF3 OA investigational vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 30 days post-vaccination (Day 31)

Secondary outcomes (6)

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

    MGI was defined as the geometric mean of the within participant ratios of the post-vaccination RSV PreF3 IgG concentration over the pre-vaccination RSV PreF3 IgG concentration.

    Measured: At 30 days post-vaccination (Day 31)

  2. Percentage of Participants Reporting Solicited Administration Site Events

    Solicited administration site adverse events (AEs) assessed were erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade.

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

  3. Percentage of Participants Reporting Solicited Systemic Events

    Solicited systemic events assessed were arthralgia, fatigue, fever [defined as temperature equal to or above (>=) 38 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F)}, headache and myalgia. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.

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

  4. Percentage of Participants Reporting at Least One Unsolicited Adverse Event

    An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Unsolicited AEs include serious, non-serious AEs and potential immune-mediated diseases (pIMDs).

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

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

    An 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. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.

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

  6. Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2021
  2. Study start1 Oct 2021
  3. Primary completion24 Jan 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
770 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05059301
Sponsor's protocol ID
217131
Other IDs
2021-002225-18
Status last verified
Jan 2023
First submitted
17 Sep 2021
Last updated
15 Feb 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • 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.

    PubMed 38746060

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVPreF3 OA investigational vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 19 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Canada, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RSVPreF3 Specific Immunoglobin (Ig)G Antibody Concentrations Expressed as Group Geometric Mean Concentration (GMC) (time frame: At 30 days post-vaccination (Day 31)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05059301, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.

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