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NCT06551181

A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older

Completed Phase 3 Last updated 11 February 2026
What this trial tests

Phase 3 trial testing RSVPreF3 OA investigational vaccine in Respiratory Syncytial Virus Infections in 2,621 participants. Completed in 15 September 2025.

Timeline
5 August 2024
Primary endpoint
24 April 2025
15 September 2025

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment2,621
Start date5 August 2024
Primary completion24 April 2025
Estimated completion15 September 2025
Sites40 locations across Finland, Japan, United Kingdom, Poland, South Korea, China, Spain

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

60 and older, any sex, with Respiratory Syncytial Virus Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the current study is to evaluate the immune response of the RSVPreF3 OA investigational vaccine in older adults (OA) at least (\>=) 60 years of age (YOA) in China compared to OA in the same age range to be enrolled from overseas countries that participated in the RSV OA=ADJ-006 (NCT04886596) study, since the vaccine efficacy against lower respiratory tract disease (LRTD) has been demonstrated following a single dose of the RSVPreF3 OA investigational vaccine in the global efficacy study RSV OA=ADJ-006. In addition, the safety (in all participants) , reactogenicity and occurrence of RSV-associated acute respiratory illness (ARI) (in study participants in China only) after administration of the vaccine are also assessed in the current study. No ARI surveillance will be conducted for the overseas participants.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A comparative study of incidence rate and severity of influenza virus and respiratory syncytial virus associated hospitalisation in older adults in Jiangsu Province, China: a retrospective analysis of a regional medical database.
    Zhang T, Guo L, Miao Y, Wang C, et al · · 2026 · PMID 41886634 · DOI 10.7189/jogh.16.04115
  2. Respiratory Syncytial Virus (RSV): A Comprehensive Overview From Basic Biology to Clinical Prevention and Control.
    Shi J, Huang X, Ye C, Lu Y, et al · · 2026 · PMID 41261734 · DOI 10.1002/med.70025

Verify or expand the search:

Other trials of RSVPreF3 OA investigational vaccine

Trials testing the same drug.

Other recruiting trials for Respiratory Syncytial Virus Infections

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06551181.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing