Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-02 @ 4:11 AM
Study NCT ID:
NCT05242432
Status:
TERMINATED
Last Update Posted:
2025-05-23
First Post:
2022-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Adenovirus Serotype 26.Respiratory Syncytial Virus.Pre-Fusion F (Ad26.RSV.preF)-Based Vaccine for Prevention of Respiratory Syncytial Virus (RSV) Mediated- Lower Respiratory Tract Disease (LRTD) in Japanese Participants
Sponsor:
Janssen Pharmaceutical K.K.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Efficacy, Safety, Reactogenicity, and Immunogenicity of an Ad26.RSV.preF-based Vaccine in Japanese Adults Aged 60 Years and Older, and Safety, Reactogenicity, and Immunogenicity of the Vaccine in Japanese Adults Aged 20 to 59 Years at High-risk of RSV Disease
Status:
TERMINATED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated (Janssen made the strategic decision to discontinue the RSV3007 study. This decision is not based on any safety concerns.)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the efficacy of study vaccine in the prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-confirmed RSV mediated- lower Respiratory Tract Disease (LRTD) over one RSV season when compared to placebo in adults aged 60 years and above and to demonstrate the non-inferiority of the vaccine in high-risk adults aged 20 to 59 years versus in adults aged 60 years and older in terms of humoral immune response.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| VAC18193RSV3007 | OTHER | Janssen Pharmaceutical K.K., Japan | View |