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Trial record 1 of 1 for:    NCT01298479
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Sayana-Uniject Volumetric Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01298479
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : December 7, 2018
Information provided by (Responsible Party):

Tracking Information
First Submitted Date December 16, 2010
First Posted Date February 17, 2011
Last Update Posted Date December 7, 2018
Study Start Date May 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 16, 2011)
Weight of drug suspension delivered (estimated by change in mass of the Uniject(TM) delivery system). [ Time Frame: Visit 1 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Sayana-Uniject Volumetric Delivery
Official Title Quantitative Determination of the Volume of Suspension Delivered Via the Uniject Delivery System Following Simulated Subcutaneous Injection by Healthcare Professionals Into a Synthetic Subcutaneous Injection Training Device
Brief Summary The purpose of this study is to determine the volumetric delivery of the Uniject.
Detailed Description Observe subjects deliver the drug None used
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population nurses
Condition Volume Delivery
Intervention Other: Uniject
single use container
Study Groups/Cohorts Group 1
All subjects
Intervention: Other: Uniject
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 16, 2011)
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Nurses

Exclusion Criteria:

  • Non-nurses
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
Administrative Information
NCT Number NCT01298479
Other Study ID Numbers A6791034
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Study Director: Pfizer Call Center Pfizer
PRS Account Pfizer
Verification Date December 2018