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NCT05327816 · ClinicalTrials.gov registry record · Phase 1
A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older
A Phase 1 study, sponsored by Janssen Vaccines & Prevention B.V..
- Terminated
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
NCT05327816: Clinical Trial Phase 1 study, sponsored by Janssen Vaccines & Prevention B.V..
NCT05327816 is a Phase 1 study that was terminated before completion, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 132 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05327816, a Phase 1 study, was terminated before completion, sponsored by Janssen Vaccines & Prevention B.V..
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate safety and immunogenicity of various respiratory syncytial virus (RSV) pre-Fusion (preF)-based vaccine components followed by expanded safety evaluation and durability/revaccination evaluation of the selected RSV preF-based vaccine formulation in participants aged greater than or equal to (\>=) 60 years in stable health.
Primary Outcome
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspec
Interventions
- DRUG Placebo
- BIOLOGICAL RSV preF-based Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2022-04-13 |
| Est. Completion | 2023-02-14 |
| Phase | Phase 1 |
Why NCT05327816 stopped before completion
NCT05327816 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05327816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05327816 about?
NCT05327816 is a clinical study titled "A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older". The purpose of the study is to evaluate safety and immunogenicity of various respiratory syncytial virus (RSV) pre-Fusion (preF)-based vaccine components followed by expanded safety evaluation and durability/revaccination evaluation of the selected RSV preF-based vaccine formulation in participants ...
What is the current status of trial NCT05327816?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2022-04-13. Estimated completion is 2023-02-14.
What interventions are being tested in trial NCT05327816?
The interventions under investigation include: Placebo (DRUG), RSV preF-based Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05327816?
This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05327816's enrollment target sits among peer trials
132 432nd of 2000 higher than 1,562 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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