Study Evaluating Serum Collected From Healthy Adults For Development of Pneumococcal Opsonophagocytic Assay
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00508950
First received: July 27, 2007
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
The study will identify healthy adults who have been vaccinated against pneumococcus, and collect blood for the purpose of developing laboratory assays.
| Condition | Intervention |
|---|---|
|
Healthy |
Procedure: Large volume blood draw |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Blood Collection in Healthy Adult Volunteers to Obtain Serum for Use in Opsonophagocytic-Assay Development |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 108 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
All subjects
All subjects
|
Procedure: Large volume blood draw
Large volume blood draw
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508950
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, New Jersey | |
| Pfizer Investigational Site | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00508950 History of Changes |
| Other Study ID Numbers: | 6115A1-1000, B1851075 |
| Study First Received: | July 27, 2007 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Pfizer:
|
Vaccines Pneumococcal Conjugate Vaccine Adult |
ClinicalTrials.gov processed this record on May 16, 2013