Evaluation of a Single Vaccination of One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) and a Single Dose Level of a 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) in Healthy Adults Aged 65 to <86 Years
Public ClinicalTrials.gov record NCT01643941. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2 Placebo-controlled, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 3 Ascending Dose Levels Of A 4-antigen Staphylococcus Aureus Vaccine (sa4ag) And A Single Dose Level Of A 3-antigen Staphylococcus Aureus Vaccine (sa3ag) In Healthy Adults Aged 65 To <86 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 1 and Phase 2 study of a single vaccination with one of three dose levels of a 4-antigen investigational vaccine against Staphylococcus aureus (SA4Ag) and a single dose level of a 3-antigen Staphylococcus aureus vaccine (SA3Ag). 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 65 to \<86 years. In addition, the study aims to assess the effect of the Staphylococcus aureus vaccine on the presence of the Staphylococcus aureus within the nose, throat and perineal skin of healthy adults aged 65 to \<86 years.
Study identification
- NCT ID
- NCT01643941
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 284 participants
Conditions and interventions
Conditions
Interventions
- SA4Ag vaccine low dose Biological
- Blood draw Procedure
- Colonization swab sample Procedure
- SA4Ag vaccine mid dose Biological
- SA4Ag vaccine high dose Biological
- SA3Ag vaccine Biological
- Blood sample Procedure
- Placebo Biological
- Colonization swab samples Procedure
Biological · Procedure
Eligibility (public fields only)
- Age range
- 65 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2012 (Type not available)
- Primary completion
- May 2013 (Actual)
- Completion
- Mar 2014 (Actual)
- Last update posted
- Mar 4, 2019
2012 – 2014
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Broward Research Group | Hollywood | Florida | 33024 | — |
| Miami Research Associates | South Miami | Florida | 33143 | — |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | — |
| PMG Research of Raleigh, LLC | Cary | North Carolina | 27518 | — |
| Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies | Cincinnati | Ohio | 45206 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Benchmark Research | Austin | Texas | 78705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01643941, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 4, 2019 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01643941 live on ClinicalTrials.gov.