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NCT01364571 · ClinicalTrials.gov registry record · Phase 1
Evaluation of a Single Vaccination With One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 456
- Enrollment target
NCT01364571 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 456 participants.
The verdict
NCT01364571, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 456 participants
- Enrollment target
Study Summary
This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The main goal of the study is to determine how safe and well tolerated the vaccine is as well as to describe the immune response elicited by the vaccine in healthy adults aged 18 to \<65 years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence of the Staphylococcus aureus on the skin and within the nose, throat and perineum of healthy adults aged 18 to \<65 years.
Interventions
- PROCEDURE Blood draw
- PROCEDURE Blood sample
- BIOLOGICAL SA4Ag vaccine low dose
- PROCEDURE Colonization swab sample
- BIOLOGICAL SA4Ag vaccine mid dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 456 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01364571
The ClinicalTrials.gov registry entry for NCT01364571 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 456 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Blood draw is the first listed.
NCT01364571 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01364571 about?
NCT01364571 is a clinical study titled "Evaluation of a Single Vaccination With One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years". This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The main goal of the study is to determine how safe and well tolerated the vaccine is as well as to describe the immune resp...
What is the current status of trial NCT01364571?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 456 participants. The study started on 2011-08. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01364571?
The interventions under investigation include: Blood draw (PROCEDURE), Blood sample (PROCEDURE), SA4Ag vaccine low dose (BIOLOGICAL), Colonization swab sample (PROCEDURE), SA4Ag vaccine mid dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT01364571?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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