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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: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT03819049 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 836 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1293% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants with solicited local AEs for 14 days after vaccination on Day 1 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local (inject
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 |
What the finished NCT03819049 record still lists
NCT03819049 is an interventional study that assigns participants to a tested intervention. The registered 836 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 (1293% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03819049 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03819049's enrollment target sits among peer trials
836 12th of 2000 higher than 1,989 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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