Study Evaluating Serum Collected From Healthy Adults For Development of Pneumococcal Opsonophagocytic Assay
NCT00508950
ABOUT THIS STUDY
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- Healthy adults 18-70 years of age
- Must have received 23vPS pneumococcal vaccine
- Bleeding diathesis
- Pregnancy
- Chronic disease which could be worsened by donating blood
- Receipt of blood, blood products or immune globulin within six months
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Descriptive Information | ||||
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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 | 152 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |