Blood Collection In Healthy Adult Volunteers To Obtain Serum For Use In Serum Bactericidal Activity Assay Development
This study is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00401232
First received: November 17, 2006
Last updated: June 14, 2013
Last verified: June 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 17, 2006 | ||||
| Last Updated Date | June 14, 2013 | ||||
| Start Date ICMJE | August 2006 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
"No outcome measures". Blood collected for assay development. [ Time Frame: 1 hour ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
To evaluate whether blood sera is suitable for assay development | ||||
| Change History | Complete list of historical versions of study NCT00401232 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Blood Collection In Healthy Adult Volunteers To Obtain Serum For Use In Serum Bactericidal Activity Assay Development | ||||
| Official Title ICMJE | Blood Collection in Healthy Adult Volunteers to Obtain Serum for Use in Serum Bactericidal Activity Assay Development | ||||
| Brief Summary | This is a study to collect blood from volunteers to assist in assay development. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Healthy Subjects | ||||
| Intervention ICMJE | Procedure: Blood Collection
Blood Collection |
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| Study Arm (s) | Arm 1
Intervention: Procedure: Blood Collection |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 900 | ||||
| Estimated Completion Date | December 2015 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 64 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00401232 | ||||
| Other Study ID Numbers ICMJE | 6108A1-800, B1971032 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||
| Verification Date | June 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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