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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: Completed Phase 1 study, sponsored by Pfizer.

NCT01364571 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 456 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (660% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 456 participants
Start Date 2011-08
Est. Completion 2013-01
Phase Phase 1
Pfizer

1,845 total trials

What the finished NCT01364571 record still lists

NCT01364571 is an interventional study that assigns participants to a tested intervention. The registered 456 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 (660% higher).

The record links to 0 conditions, and to 5 interventions - of which Blood draw is the first listed.

NCT01364571 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01364571's enrollment target sits among peer trials

456 54th of 2000 higher than 1,947 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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Source: ClinicalTrials.gov NCT01364571, the US trial registry maintained by the National Library of Medicine. NCT01364571 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.