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NCT02388165 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
A Phase 2 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3,450
- Enrollment target
NCT02388165: Clinical Trial Phase 2 study, sponsored by Pfizer.
NCT02388165 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 3,450 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (2494% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02388165, a Phase 2 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3,450 participants
- Enrollment target
Study Summary
The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective spinal surgery.
Primary Outcome
BSI: clinical infection involved a recognized pathogen (S. aureus) cultured from 1 or more blood cultures or a commensal organism cultured from 2 or more blood cultures whether primary or secondary to infection at another site. SSI: infection at a surgical incision. Types of SSI in this outcome measure: Deep incisional SSI: infection involved deep soft tissues of incision (example \[e.g.\] fascial and muscle layers), Organ/space SSI: infection involved any part of body excluding skin incision, f
Interventions
- OTHER Placebo
- BIOLOGICAL Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,450 participants |
| Start Date | 2015-07-02 |
| Est. Completion | 2019-06-27 |
| Phase | Phase 2 |
Why NCT02388165 stopped before completion
NCT02388165 is an interventional study that assigns participants to a tested intervention. Its 3,450 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (2494% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02388165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02388165 about?
NCT02388165 is a clinical study titled "Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation". The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective spinal surgery.
What is the current status of trial NCT02388165?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3,450 participants. The study started on 2015-07-02. Estimated completion is 2019-06-27.
What interventions are being tested in trial NCT02388165?
The interventions under investigation include: Placebo (OTHER), Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02388165?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02388165's enrollment target sits among peer trials
3,450 6th of 2000 higher than 1,995 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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