AzTrials
AzTrials

Respiratory Syncytial Virus InfectionsPhase 3NCT06389487

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above

A Phase 3 study testing RSVPreF3 OA investigational vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 52 sites in 6 countries.

Completed

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

Official record
Search all trials

Trial summary

The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for RSV disease, compared to older adults (OA) 60 YOA and above. Read more about this study

Who is it for?
Ages 18 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
1,459 participants
Where
52 sitesin 6 countries
Study dates
29 Apr 2024to 18 Mar 2025
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants and/or participant's parent(s)/ Legally acceptable representative (LAR) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attend study site visits, ability to access and utilize a phone or other electronic communications).
  • Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.
  • Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than the legal age prior to performance of any study-specific procedure.
  • Specific inclusion criteria for all participants in Cohort 1 and Cohort 3 (RSV-A-AIR Group) • A male or female participant 18-49 YOA at the time of the study intervention administration.
  • Participants should be diagnosed with at least 1 of the following medical conditions if considered medically stable by the investigator:
  • Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of long term medication:
Show all 27Show fewer
  • o Chronic obstructive pulmonary disease (COPD)
  • o Asthma
  • o Cystic fibrosis
  • o Other chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis
  • o Chronic heart failure:
  • o Pre-existing Coronary Artery Disease (CAD) (CAD not otherwise specified)
  • Cardiac arrhythmia
  • Diabetes mellitus: types 1 or 2 with active treatment for the past 6 months
  • Other diseases at increased risk for RSV disease:
  • Chronic kidney disease
  • Chronic moderate to severe liver disease
  • Neurologic or neuromuscular conditions
  • Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as premenarche, hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause.
  • Female participants of childbearing potential may be enrolled in the study, if the participant:
  • has practiced adequate contraception from 1 month prior to study intervention administration, and
  • has a negative pregnancy test on the day of study prior to intervention administration, and
  • has agreed to continue adequate contraception for at least 1 month after completion of the study intervention administration.
  • Specific inclusion criteria for all participants in Cohort 2 (RSV-OA Group):
  • A male or female participant >=60 YOA at the time of the study intervention administration.
  • Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered medically stable by the investigator.
  • 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.

Who cannot join

  • Medical conditions
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), 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.
  • Unstable chronic illness.
  • Any history of dementia or any medical condition that moderately or severely impairs cognition.
  • Recurrent or uncontrolled 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 the diary cards, attend study site visits). Study participants may decide to assign a caregiver to help them complete the study procedures.
Show all 29Show fewer
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease).
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
  • Prior/Concomitant therapy
  • Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 3, Month 6).
  • 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 dose of study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration.
  • Previous vaccination with any RSV vaccine, including investigational RSV vaccines.
  • Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the End-of-study (EOS).
  • Up to 3 months prior to the study intervention administration:
  • For corticosteroids, this will mean prednisone >=20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed
  • Administration of immunoglobulins and/or any blood products or plasma derivatives
  • Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., Tumor Necrosis Factor (TNF)-inhibitors), monoclonal antibodies, antitumoral medication.
  • 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:
  • Other exclusions for all participants:
  • 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.
  • Bedridden participants.
  • Planned move during the study period that will prohibit participating in the study until study end.
  • Participation of any study personnel or their immediate dependents, family, or household members.
  • Other exclusions for Cohort 1 and Cohort 3:
  • Pregnant or lactating female participant.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions within 1 month after study intervention administration.

Trial locations and contacts

52 sites in 6 countries.

52 sites in 6 countries

United States16 sites

  • GSK Investigational Site

    Charlottesville, Virginia, 22911

  • GSK Investigational Site

    DeSoto, Texas, 75115

  • GSK Investigational Site

    Glendale, Arizona, 85308

  • GSK Investigational Site

    Hialeah, Florida, 33012

  • GSK Investigational Site

    Knoxville, Tennessee, 37909

  • GSK Investigational Site

    Lexington, Kentucky, 40509

  • GSK Investigational Site

    North Hollywood, California, 91606-3287

  • GSK Investigational Site

    North Miami, Florida, 33173

  • GSK Investigational Site

    Oakland, California, 94610

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73111

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    Phoenix, Arizona, 85284

  • GSK Investigational Site

    Rochester, New York, 14609

  • GSK Investigational Site

    Silver Spring, Maryland, 20904

  • GSK Investigational Site

    Walnut Creek, California, 94598

  • GSK Investigational Site

    Wenatchee, Washington, 98801

Other trials in United States

Canada12 sites

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3C 1X3

  • GSK Investigational Site

    Guelph, Ontario, N1G 0B4

  • GSK Investigational Site

    London-Ontario, Ontario, N5W 6A2

  • GSK Investigational Site

    New Westminster, British Columbia, V3L 3W4

  • GSK Investigational Site

    Québec, Quebec, G1N 4V3

  • GSK Investigational Site

    Québec, Quebec, G1V 4G2

  • GSK Investigational Site

    Québec, Quebec, G1V 4W2

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • GSK Investigational Site

    Sherbrooke, Quebec, J1J 2G2

  • GSK Investigational Site

    Toronto, Ontario, M4G 3E8

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Victoria, British Columbia, V8V 4A1

Other trials in Canada

Germany9 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 13347

  • GSK Investigational Site

    Essen, 45355

  • GSK Investigational Site

    Mainz, 55116

  • GSK Investigational Site

    Wallerfing, 94574

  • GSK Investigational Site

    Weinheim, Baden-Wurttemberg, 69469

  • GSK Investigational Site

    Witten, 58455

  • GSK Investigational Site

    Würzburg, 97070

Other trials in Germany

Australia7 sites

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450

  • GSK Investigational Site

    Fortitude Valley, Queensland, 4006

  • GSK Investigational Site

    Melbourne, Victoria, 3051

  • GSK Investigational Site

    St Albans, Victoria, 3021

  • GSK Investigational Site

    Sydney, New South Wales, 2010

  • GSK Investigational Site

    Sydney, New South Wales, 2065

  • GSK Investigational Site

    Tarragindi, Queensland, 4121

Other trials in Australia

Japan4 sites

  • GSK Investigational Site

    Ibaraki, 300-0062

  • GSK Investigational Site

    Kanagawa, 211-0041

  • GSK Investigational Site

    Tokyo, 155-0031

  • GSK Investigational Site

    Tokyo, 180-0022

Other trials in Japan

South Africa4 sites

  • GSK Investigational Site

    Cape Town, 7530

  • GSK Investigational Site

    Cape Town, 7700

  • GSK Investigational Site

    Johannesburg, 2113

  • GSK Investigational Site

    Reiger Park, 1459

Other trials in South Africa

About this study

Official title: A Phase 3b, Open-label Study to Evaluate the Non-inferiority of the Immune Response and to Evaluate the Safety of the RSVPreF3 OA Investigational Vaccine in Adults 18-49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults >=60 Years of Age

The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for RSV disease, compared to older adults (OA) 60 YOA and above.

Being tested
RSVPreF3 OA investigational vaccine
Keywords
Respiratory Syncytial Virus (RSV), Immunogenicity, Safety, Non-inferiority, Humoral immune response, At increased risk (AIR), Older Adults
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

    1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1.

Study groups in NCT06389487
Study groupRoleWhat they receive
Part A: RSV-A-AIR GroupExperimentalAdult (A) participants, 18-49 YOA, at increased risk (AIR) for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.
Receives: Biological: RSVPreF3 OA investigational vaccine
Part A: RSV-OA GroupActive comparatorOlder adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
Receives: Biological: RSVPreF3 OA investigational vaccine
Part B: RSV-A-AIR GroupExperimentalAdult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Receives: Biological: RSVPreF3 OA investigational vaccine

What is being measured

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

  1. Part A: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)

    RSV-A neutralizing titers are given as group GMTs and are expressed as Estimated dilution 60 (ED60)

    Measured: At Day 31

  2. Part A: Percentage of Participants With Seroresponse Rate (SRR) in RSV-A Neutralizing Titers

    SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration) ≥4. RSV-A neutralizing titers are expressed as ED60.

    Measured: Day 31 compared with baseline (Day 1)

  3. Part A: RSV-B Neutralizing Titers Expressed as Group GMTs

    RSV-B neutralizing titers are given as group GMTs and are expressed as ED60.

    Measured: At Day 31

  4. Part A: Percentage of Participants With SRR in RSV-B Neutralizing Titers

    SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1-month post-study intervention administration over pre-study intervention administration) ≥ 4. RSV-B neutralizing titers are expressed as ED60.

    Measured: Day 31 compared with baseline (Day 1)

Secondary outcomes (7)

  1. Part A and B: Number of Participants Reporting Any Solicited Administration Site Events

    Assessed solicited administration site events were pain, redness (erythema) and swelling at administration site. Any = occurrence of the symptom regardless of intensity grade.

    Measured: Day 1 (post dose) to Day 4

  2. Part A and B: Number of Participants Reporting Any Solicited Systemic Events

    Assessed solicited systemic events were fever (pyrexia), headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness). Fever was defined as temperature ≥38.0 degrees Celsius (°C), regardless of the location of measurement. The route for measuring temperature could be oral or axillary. Any = occurrence of the symptom regardless of intensity grade.

    Measured: Day 1 (post dose) to Day 4

  3. Part A and B: Number of Participants Reporting Unsolicited Adverse Events (AEs)

    An unsolicited AE wass an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs included both serious and non-serious AEs.

    Measured: Day 1 (post dose) to Day 30

  4. Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs

    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, is considered or defined as an important medical event, or abnormal pregnancy outcomes. Any SAE = occurrence of the SAE regardless of the intensity grade or relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.

    Measured: Throughout the study period (Day 1 to Month 6)

  5. Part A and B: Number of Participants Reporting Any Adverse Events of Special Interest (AESIs)

    AESIs assessed were potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF). pIMDs were a subset of AESIs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. AEs of AF were considered as AESI.

    Measured: Throughout the study period (Day 1 to Month 6)

  6. Part A: RSV-A Neutralizing Titers Expressed as GMTs

    RSV-A neutralizing titers are given as GMTs and are expressed as ED60.

    Measured: At Day 1 (pre-dose), at Month 1 and Month 6

  7. Part A: RSV-B Neutralizing Titers Expressed as GMTs

    RSV-B neutralizing titers are given as GMTs and are expressed as ED60.

    Measured: At Day 1 (pre-dose), at Month 1 and Month 6

Timeline

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

  1. First posted29 Apr 2024
  2. Study start29 Apr 2024
  3. Primary completion29 Jul 2024
  4. Study completion18 Mar 2025

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,459 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06389487
Sponsor's protocol ID
222253
Other IDs
2023-510190-34-00, 2023
Status last verified
Sep 2025
First submitted
24 Apr 2024
Last updated
25 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer tohttps://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf

Publications

  • Mitha E, Ferguson M, Wilhase AC, De Looze F, Vachon ML, Stacey H, Rasalam R, Nozaki M, Smith WB, Schwarz TF, Hailemariam HA, Deraedt Q, Gerard C, Vanden Abeele C, Damaso S, Descamps D, Hill J, Dasyam D, Van Gucht J, Hulstrom V. Immunogenicity and Safety of the AS01E-adjuvanted Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine in Adults Aged 18-49 Years at Increased Risk of RSV Disease Compared with Adults Aged >/=60 Years. Clin Infect Dis. 2026 May 20;82(5):e1093-e1103. doi: 10.1093/cid/ciag058.

    PubMed 41757519

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 52 sites in 6 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 27 inclusion and 29 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 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Canada, Germany, Australia, Japan and 1 more country. 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 25 Sep 2025). 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?

Part A: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs) (time frame: At Day 31). The study lists 4 primary outcomes in all. 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 NCT06389487, 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 25 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in