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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
Phase 3 trial testing RSVPreF3 OA investigational vaccine in Respiratory Syncytial Virus Infections in 2,621 participants. Completed in 15 September 2025.
24 April 2025
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 2,621 |
| Start date | 5 August 2024 |
| Primary completion | 24 April 2025 |
| Estimated completion | 15 September 2025 |
| Sites | 40 locations across Finland, Japan, United Kingdom, Poland, South Korea, China, Spain |
Drugs / interventions tested
- RSVPreF3 OA investigational vaccine — full drug profile →
- Placebo
Conditions studied
- Respiratory Syncytial Virus Infections — all drugs for Respiratory Syncytial Virus Infections →
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):
-
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 -
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:
- PubMed search for NCT06551181
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of RSVPreF3 OA investigational vaccine
Trials testing the same drug.
- NCT06614725 — A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When · Phase 3 · completed
- NCT06374394 — A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and To · Phase 3 · completed
- NCT06389487 — A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 · Phase 3 · completed
- NCT05966090 — A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Hea · Phase 3 · completed
- NCT05879107 — Study to Assess the Immune Response, the Safety and the Reactogenicity of Respiratory Syncytial Virus (RSV) Prefusion Pr · Phase 3 · completed
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Currently open trials in the same condition.
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Other GlaxoSmithKline trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06551181 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 11 February 2026
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