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Trial record 1 of 1 for:    NCT00508950
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Study Evaluating Serum Collected From Healthy Adults For Development of Pneumococcal Opsonophagocytic Assay

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ClinicalTrials.gov Identifier: NCT00508950
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 27, 2007
First Posted Date  ICMJE July 30, 2007
Last Update Posted Date August 17, 2016
Study Start Date  ICMJE August 2007
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2012)
To identify potential serum donors and obtain unit volumes of blood from these donors for use in pneumococcal opsonophagocytic assay development. [ Time Frame: 8 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 27, 2007)
To identify potential donors of serum for use in pneumococcal opsonophagocytic-assay development and to obtain unit volumes of blood from these donors for use in pneumococcal opsonophagocytic-assay development.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Serum Collected From Healthy Adults For Development of Pneumococcal Opsonophagocytic Assay
Official Title  ICMJE Blood Collection In Healthy Adult Volunteers To Obtain Serum For Use In Pneumococcal Opsonophagocytic Assay Development.
Brief Summary The study will identify healthy adults who have been vaccinated against pneumococcus, and collect blood for the purpose of developing laboratory assays.
Detailed Description Collect serum with antibody levels capable of killing pneumococcal bacteria from healthy prevaccinated adults to develop OPA assays for the 13 serotypes in 13-valent pneumococcal conjugate vaccine.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Condition  ICMJE Healthy
Intervention  ICMJE Procedure: Large volume blood draw
Large volume blood draw
Study Arms  ICMJE All subjects
All subjects
Intervention: Procedure: Large volume blood draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2016)
152
Original Enrollment  ICMJE
 (submitted: July 27, 2007)
108
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adults 18-70 years of age
  • Must have received 23vPS pneumococcal vaccine

Exclusion Criteria:

  • Bleeding diathesis
  • Pregnancy
  • Chronic disease which could be worsened by donating blood
  • Receipt of blood, blood products or immune globulin within six months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00508950
Other Study ID Numbers  ICMJE 6115A1-1000
B1851075 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP