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NCT02546960 · ClinicalTrials.gov registry record · Phase 2
A Study in Healthy Adults to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 848
- Enrollment target
NCT02546960: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT02546960 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 848 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (538% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02546960, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 848 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability of different doses of JNJ-63871860 (ExPEC4V) in participants greater than or equal to (\>=)18 years of age and to evaluate the dose-dependent immunogenicity of ExPEC as measured by enzyme-linked immunosorbent assay (ELISA).
Primary Outcome
Solicited AEs are precisely defined events that participants are specifically asked about and which are noted by participants through the electronic Subject Diary. Solicited Local AEs: Participants will be instructed on how to note occurrences of pain/tenderness, erythema, and induration/swelling at the injection site daily for 8 days postvaccination (day of vaccination and the subsequent 7 days) in the electronic Subject Diary. Participants will be instructed on how to measure (using the ruler
Interventions
- BIOLOGICAL ExPEC4V (4 : 4 : 4 : 4)
- BIOLOGICAL ExPEC4V (4 : 4 : 4 : 8)
- BIOLOGICAL ExPEC4V (8 : 8 : 8 : 8)
- BIOLOGICAL ExPEC4V (8 : 8 : 8 : 16)
- BIOLOGICAL ExPEC4V (16 : 16 : 16 : 16)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 848 participants |
| Start Date | 2015-11-12 |
| Est. Completion | 2019-06-21 |
| Phase | Phase 2 |
What the finished NCT02546960 record still lists
NCT02546960 is an interventional study that assigns participants to a tested intervention. The registered 848 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (538% higher).
The record links to 0 conditions, and to 5 interventions - of which ExPEC4V (4 : 4 : 4 : 4) is the first listed.
NCT02546960 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02546960 about?
NCT02546960 is a clinical study titled "A Study in Healthy Adults to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860". The purpose of this study is to evaluate the safety, tolerability of different doses of JNJ-63871860 (ExPEC4V) in participants greater than or equal to (\>=)18 years of age and to evaluate the dose-dependent immunogenicity of ExPEC as measured by enzyme-linked immunosorbent assay (ELISA).
What is the current status of trial NCT02546960?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 848 participants. The study started on 2015-11-12. Estimated completion is 2019-06-21.
What interventions are being tested in trial NCT02546960?
The interventions under investigation include: ExPEC4V (4 : 4 : 4 : 4) (BIOLOGICAL), ExPEC4V (4 : 4 : 4 : 8) (BIOLOGICAL), ExPEC4V (8 : 8 : 8 : 8) (BIOLOGICAL), ExPEC4V (8 : 8 : 8 : 16) (BIOLOGICAL), ExPEC4V (16 : 16 : 16 : 16) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02546960?
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 NCT02546960's enrollment target sits among peer trials
848 36th of 2000 higher than 1,965 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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