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NCT03500679 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Safety and Immunogenicity of the ExPEC4V Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Participants Aged 18 Years and Older
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT03500679 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 100 participants.
The verdict
NCT03500679, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety/reactogenicity of the ExPEC4V clinical trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the first vaccination (on Day 15).
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL ExPEC4V
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-05-09 |
| Est. Completion | 2019-06-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03500679
The ClinicalTrials.gov registry entry for NCT03500679 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 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 2 interventions - of which Placebo is the first listed.
NCT03500679 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03500679 about?
NCT03500679 is a clinical study titled "A Study to Evaluate Safety and Immunogenicity of the ExPEC4V Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Participants Aged 18 Years and Older". The purpose of this study is to evaluate the safety/reactogenicity of the ExPEC4V clinical trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the first vaccination (on Day...
What is the current status of trial NCT03500679?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2018-05-09. Estimated completion is 2019-06-11.
What interventions are being tested in trial NCT03500679?
The interventions under investigation include: Placebo (BIOLOGICAL), ExPEC4V (BIOLOGICAL).
Who is sponsoring clinical trial NCT03500679?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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