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

NCT07220109 | Recruiting Phase 3 DMC

• 1 other identifier: 223372
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 13

Brief 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; NCT06551181) study following a single dose of the RSVPreF3 OA vaccine. In addition, the safety and reactogenicity of the vaccine will also be assessed.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory syncytial virus (RSV); Immunogenicity; Safety; Reactogenicity; Older adults at increased risk (OA AIR)

Outcome Measures

Primary Outcomes (4)

• 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).

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

• 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).

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

• 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).

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

• 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).

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

Secondary Outcomes (12)

• RSV-A and RSV-B neutralizing titers expressed as group GMTs

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

• RSV-A and RSV-B neutralizing titers expressed as group SRR

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

• 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

  Day 1 to Month 6 of the current study

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

  Day 1 to Month 6 of the current study

• 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

  Day 1 to Month 6 of the current study

Study Arms (2)

RSV AIR group

EXPERIMENTAL

Participants at increased risk (AIR) of RSV disease will receive a single dose of investigational RSVPreF3 OA investigational vaccine on Visit 1 (Day 1).

Biological: RSVPreF3 OA vaccine

Placebo AIR group

PLACEBO COMPARATOR

Participants AIR of RSV disease will receive a single dose of Placebo on Visit 1 (Day 1).

Biological: Placebo

Interventions

RSVPreF3 OA vaccine BIOLOGICAL

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

RSV AIR group

Placebo BIOLOGICAL

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

Placebo AIR group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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:

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.
• 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.
• 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:

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

Beijing, Beijing Municipality, 100049, China

RECRUITING

GSK Investigational Site

Xiangtan, Hunan, 411228, China

RECRUITING

GSK Investigational Site

Nanjing, Jiangsu, 211112, China

RECRUITING

GSK Investigational Site

Chengdu, Sichuan, 611130, China

RECRUITING

GSK Investigational Site

Chengdu, 610072, China

RECRUITING

GSK Investigational Site

Chongqing, 400030, China

RECRUITING

GSK Investigational Site

Guangzhou, 510180, China

RECRUITING

GSK Investigational Site

Guangzhou, 510220, China

RECRUITING

GSK Investigational Site

Jiujiang, China

RECRUITING

GSK Investigational Site

Nanning, 530000, China

RECRUITING

GSK Investigational Site

Shanghai, 200000, China

RECRUITING

GSK Investigational Site

Shanghai, 200040, China

RECRUITING

GSK Investigational Site

Zhuhai, 519099, China

RECRUITING

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer blind study: participants the site and sponsor personnel involved in the clinical evaluation of the participants are blinded while the treatment is administered by unblinded study personnel who will not participate in data collection evaluation or review of any study endpoint.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: October 23, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): July 16, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.

Locations

CN (13)