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NCT02415387 · ClinicalTrials.gov registry record · Early Phase 1
Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer
A Early Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 172
- Enrollment target
NCT02415387: Completed Early Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.
NCT02415387 is a Early Phase 1 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 172 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (225% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02415387, a Early Phase 1 study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 172 participants
- Enrollment target
Study Summary
This randomized clinical trial uses an inactive typhoid vaccine to briefly stimulate an immune response in patients with stage I-IIIA breast cancer who received primary cancer treatment and studies whether patients' fitness levels affect how their bodies handle a challenge to their immune system. A vaccine is a substance or group of substances meant to cause the immune system to respond to a tumor or to microorganisms such as bacteria or viruses. Immune responses may cause excess inflammation in the body and behavioral changes, such as depression, fatigue, pain, and problems with thinking and reasoning. Studying immune responses in patients with breast cancer who have undergone primary cancer treatment may help doctors learn whether physical fitness can protect the body from effects of immune system stress and whether it may be able to reduce health problems in patients with breast cancer.
Primary Outcome
AUC change refers to the 'net incremental' area, which is the area under the curve above the baseline value. Data points used in AUC change calculation include baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine. This can be calculated geometrically by applying the trapezoid rule. When a value falls below the baseline, only the area above the baseline level is included.
Interventions
- OTHER Placebo
- BIOLOGICAL typhoid vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2014-01-01 |
| Est. Completion | 2021-04-27 |
| Phase | Early Phase 1 |
What the finished NCT02415387 record still lists
NCT02415387 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (225% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02415387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02415387 about?
NCT02415387 is a clinical study titled "Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer". This randomized clinical trial uses an inactive typhoid vaccine to briefly stimulate an immune response in patients with stage I-IIIA breast cancer who received primary cancer treatment and studies whether patients' fitness levels affect how their bodies handle a challenge to their immune system. A ...
What is the current status of trial NCT02415387?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 172 participants. The study started on 2014-01-01. Estimated completion is 2021-04-27.
What interventions are being tested in trial NCT02415387?
The interventions under investigation include: Placebo (OTHER), typhoid vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02415387?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02415387's enrollment target sits among peer trials
172 77th of 2000 higher than 1,924 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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