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Respiratory Syncytial Virus InfectionsPhase 3NCT07220109

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

A Phase 3 study testing RSVPreF3 OA vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 15 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory syncytial virus (RSV) disease, in comparison with the immune response generated in older adults 60 YOA and above from the 219815 (RSV OA=ADJ-021… Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
RSVPreF3 OA vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
750 participants
Where
15 sitesChina
Study dates
29 Oct 2025to 31 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 to 59 years
  • All sexes
  • No healthy volunteers
  • 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.
  • Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.
  • A male or female participant 18-59 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:
  • A stable condition is defined as a disease not requiring significant change (based on the investigator's opinion) in therapy or worsening during the 3 months before enrollment.
  • -Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of long-term medication: oChronic obstructive pulmonary disease (COPD)
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  • Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade 2-4 oAsthma
  • Patient on Maintenance and Reliever Therapy (MART) OR with at least one rescue treatment per week (excluding exercise asthma) oCystic fibrosis oOther chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis oChronic heart failure:
  • A minimum of class II symptoms according to New York Heart Association classification of heart failure oPre-existing CAD (CAD not otherwise specified)
  • Physician diagnosis of CAD based on electrocardiogram, exercise stress test, nuclear stress test, cardiac computed tomography scan or cardiac angiogram (more than the presence of hypercholesterolemia) oCardiac arrhythmia
  • Patient diagnosed with a cardiac arrythmia that require medical support either pharmacologically or with a medical device -Diabetes mellitus: types 1 or 2 with active treatment for the past 6 months
  • -Other diseases at increased risk for RSV disease oChronic kidney disease
  • G2-G3 disease (Glomerular Filtration Rate between 30 and 90 mL/min/1.73 m2) oChronic moderate to severe liver disease
  • 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.

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.
  • 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. Study participants may decide to assign a caregiver to help them complete the study procedures.
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  • 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.
  • 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 Contact, 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 EOS.
  • Up to 3 months prior to the study intervention administration:
  • oFor corticosteroids, this will mean prednisone >=20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed oAdministration 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, 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 exclusion criteria
  • 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 conduct that prohibits participation until study end.
  • Participation of any study personnel or their immediate dependents, family, or household members.
  • 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

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • GSK Investigational Site

    Beijing, Beijing Municipality, 100049

  • GSK Investigational Site

    Chengdu, Sichuan, 611130

  • GSK Investigational Site

    Chengdu, 610072

  • GSK Investigational Site

    Chongqing, 400030

  • GSK Investigational Site

    Chongqing, 401336

  • GSK Investigational Site

    Guangzhou, 510180

  • GSK Investigational Site

    Guangzhou, 510220

  • GSK Investigational Site

    Jiujiang

  • GSK Investigational Site

    Kunming, 650032

  • GSK Investigational Site

    Nanjing, Jiangsu, 211112

  • GSK Investigational Site

    Nanning, 530000

  • GSK Investigational Site

    Shanghai, 200000

  • GSK Investigational Site

    Shanghai, 200040

  • GSK Investigational Site

    Xiangtan, Hunan, 411228

  • GSK Investigational Site

    Zhuhai, 519099

Other trials in China

About this study

Official title: A Phase 3, Randomized, Controlled, Observer Blind, Immuno-bridging Study to Evaluate Immunogenicity, Reactogenicity, Safety of a Single Dose of GSK's RSVPreF3 OA Investigational Vaccine in Chinese Adults 18-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory syncytial virus (RSV) disease, in comparison with the immune response generated in older adults 60 YOA and above from the 219815 (RSV OA=ADJ-021; NCT06551181) study following a single dose of the RSVPreF3 OA vaccine. In addition, the safety and reactogenicity of the vaccine will also be assessed.

Being tested
RSVPreF3 OA vaccine, Placebo
Keywords
Respiratory syncytial virus (RSV), Immunogenicity, Safety, Reactogenicity, Older adults at increased risk (OA AIR)
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 vaccineBiological

    1 dose of RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

  • PlaceboBiological

    1 dose of saline solution administered intramuscularly in the deltoid region of the non-dominant arm.

Study groups in NCT07220109
Study groupRoleWhat they receive
RSV AIR groupExperimentalParticipants at increased risk (AIR) of RSV disease will receive a single dose of investigational RSVPreF3 OA investigational vaccine on Visit 1 (Day 1).
Receives: Biological: RSVPreF3 OA vaccine
Placebo AIR groupPlacebo comparatorParticipants AIR of RSV disease will receive a single dose of Placebo on Visit 1 (Day 1).
Receives: Biological: Placebo

What is being measured

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

  1. RSV-A neutralizing titers expressed as group Geometric Mean Titers (GMTs)

    The serum neutralizing titers are expressed in Estimated Dilution (ED60). The group GMT ratio will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) over RSV AIR (from the current study).

    Measured: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)

  2. RSV-A neutralizing titers expressed as group Seroresponse rate (SRR)

    The SRR is defined as the proportion of participants having a 4-fold increase in neutralizing titers. The group SRR difference will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) minus RSV AIR (from the current study).

    Measured: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)

  3. RSV-B neutralizing titers expressed as group GMTs

    The serum neutralizing titers are expressed in ED60. The group GMT ratio will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) over RSV AIR (from the current study).

    Measured: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)

  4. RSV-B neutralizing titers expressed as group SRR

    The group SRR difference will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) minus RSV AIR (from the current study).

    Measured: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)

Secondary outcomes (12)

  1. RSV-A and RSV-B neutralizing titers expressed as group GMTs

    The serum neutralizing titers are expressed in ED60. The group GMT ratio will be evaluated for RSV-OA Chinese group (from RSV OA-ADJ-021 study) over RSV AIR (from the current study).

    Measured: At Day 31 and at Month 6 (i.e., 1 month and 6 months after RSVPreF3 OA investigational vaccine administration)

  2. RSV-A and RSV-B neutralizing titers expressed as group SRR

    The group SRR difference will be evaluated for RSV-OA Chinese group (from RSV OA-ADJ-021 study) minus RSV AIR (from the current study).

    Measured: At Day 31 and at Month 6 (i.e., 1 month and 6 months after RSVPreF3 OA investigational vaccine administration)

  3. Number of participants with RT-PCR-confirmed RSV A and/or B-associated acute respiratory illness (ARI) and lower respiratory tract disease (LRTD), assessed for all groups of the current study

    An ARI is defined as the presence of at least 2 respiratory symptoms/signs for at least 24 hours; or at least 1 respiratory symptom/sign and 1 systemic symptom/sign for at least 24 hours. An RT-PCR-confirmed RSV-ARI is an event meeting the case definition of ARI with at least one RSV-positive swab detected by RT-PCR. A LRTD is defined as the presence of at least 2 lower respiratory symptoms/signs for at least 24 hours including at least 1 lower respiratory sign; or at least 3 lower respiratory symptoms for at least 24 hours. An RT-PCR-confirmed RSV-LRTD is an event meeting the case definition of LRTD with at least one RSV-positive swab detected by RT-PCR.

    Measured: Day 1 to Month 6 of the current study

  4. Duration of RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD episodes, assessed for all the groups of the current study

    Measured: Day 1 to Month 6 of the current study

  5. Number of participants reporting symptoms/signs of RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD, assessed for all the groups of the current study

    Measured: Day 1 to Month 6 of the current study

  6. Number of participants with RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD by severity, assessed for all the groups of the current study

    Measured: Day 1 to Month 6 of the current study

  7. Number of participants with RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD by frailty status, assessed for all the groups of the current study

    Measured: Day 1 to Month 6 of the current study

  8. Number of participants with each solicited administration site event assessed for all the groups of the current study

    Solicited administration site event are pain, erythema and swelling.

    Measured: Day 1 to Day 7 of the current study

  9. Number of participants with each solicited systemic event assessed for all the groups of the current study

    Solicited systemic events are fever, myalgia (muscle pain), arthralgia (joint pain), headache and fatigue (tiredness). Fever is defined as a temperature of more than or equal to (>=) 38.0 degrees Celsius (°C).

    Measured: Day 1 to Day 7 of the current study

  10. Number of participants with unsolicited adverse events (AEs) assessed for all the groups of the current study

    An unsolicited AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention 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.

    Measured: Day 1 to Day 30 of the current study

  11. Number of participants with serious adverse events (SAEs) assessed for all the groups of the current study

    An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes, is a suspected transmission of any infectious agent via an authorized medicinal product. or any other situation considered as such by the investigator.

    Measured: Day 1 up to study end (Month 6) of the current study

  12. Number of participants with potential immune-mediated disease (pIMDs) assessed for all the groups of the current study

    PIMDs are a subset of adverse events 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: Day 1 up to study end (Month 6) of the current study

Timeline

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

  1. First posted23 Oct 2025
  2. Study start29 Oct 2025
  3. Primary completion20 Jul 2026
  4. Study completion31 Dec 2026 (estimated)

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
750 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07220109
Sponsor's protocol ID
223372
Status last verified
Nov 2026
First submitted
21 Oct 2025
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
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 to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVPreF3 OA vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 15 sites in China.

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 18 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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?

RSV-A neutralizing titers expressed as group Geometric Mean Titers (GMTs) (time frame: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)). 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 NCT07220109.

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 5 Nov 2026.

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