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NCT03819049 · ClinicalTrials.gov registry record · Phase 1
A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 836
- Enrollment target
NCT03819049 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 836 participants.
The verdict
NCT03819049, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 836 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term safety and immunogenicity of the optimal dose of ExPEC10V, selected from the primary analysis results of Cohort 1. Cohort 2 will include participants in stable health with a history of urinary tract infection (UTI) in the past 5 years and will be included in the study to support the plan for late stage development of ExPEC vaccine.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Prevnar 13
- BIOLOGICAL ExPEC10V
- BIOLOGICAL ExPEC4V
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 836 participants |
| Start Date | 2019-06-06 |
| Est. Completion | 2024-12-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03819049
The ClinicalTrials.gov registry entry for NCT03819049 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 836 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03819049 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03819049 about?
NCT03819049 is a clinical study titled "A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health". The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term safety and immunogenicity of ...
What is the current status of trial NCT03819049?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 836 participants. The study started on 2019-06-06. Estimated completion is 2024-12-18.
What interventions are being tested in trial NCT03819049?
The interventions under investigation include: Placebo (BIOLOGICAL), Prevnar 13 (BIOLOGICAL), ExPEC10V (BIOLOGICAL), ExPEC4V (BIOLOGICAL).
Who is sponsoring clinical trial NCT03819049?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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