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NCT01011335 · ClinicalTrials.gov registry record · Phase 1
Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial
A Phase 1 study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 176
- Enrollment target
NCT01011335: Completed Phase 1 study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
NCT01011335 is a Phase 1 study that has completed, run by Henry M. Jackson Foundation for the Advancement of Military Medicine. The registered enrollment target is 176 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (193% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01011335, a Phase 1 study, has completed, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 176 participants
- Enrollment target
Study Summary
This study involves the use of investigational vaccines. A vaccine is a medicine that causes the body to make antibodies. Antibodies help destroy foreign substances that enter the body. The purpose of this study is to find the right dose of a new vaccine that is safe and produces a good immune response (how well your body recognizes and defends itself against harmful foreign substances). There are two Staphylococcus aureus toxoids (components or antigens) under investigation in this study; one of them is a protein known as rAT and the other is a protein known as rLukS-PV. They are being developed to see if they are effective at preventing infections caused by the bacteria Staphylococcus aureus.
Primary Outcome
Adverse events, local reactogenicity, and systemic reactogenicity were assessed through clinical examination by study providers, clinical lab results, as well as review of subject-completed diary
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Monovalent rAT
- BIOLOGICAL Monovalent rLukS-PV
- BIOLOGICAL Bivalent rLukS-PV / rAT
- BIOLOGICAL Placebo with adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
What the finished NCT01011335 record still lists
NCT01011335 is an interventional study that assigns participants to a tested intervention. The registered 176 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 (193% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01011335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01011335 about?
NCT01011335 is a clinical study titled "Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial". This study involves the use of investigational vaccines. A vaccine is a medicine that causes the body to make antibodies. Antibodies help destroy foreign substances that enter the body. The purpose of this study is to find the right dose of a new vaccine that is safe and produces a good immune respo...
What is the current status of trial NCT01011335?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 176 participants. The study started on 2009-11. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01011335?
The interventions under investigation include: Placebo (BIOLOGICAL), Monovalent rAT (BIOLOGICAL), Monovalent rLukS-PV (BIOLOGICAL), Bivalent rLukS-PV / rAT (BIOLOGICAL), Placebo with adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT01011335?
This trial is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01011335's enrollment target sits among peer trials
176 316th of 2000 higher than 1,682 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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