Study Evaluating Serum Collected From Healthy Adults For Development of Pneumococcal Opsonophagocytic Assay

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Procedure: Large volume blood draw

• Registration Number: NCT00508950
• Lead Sponsor: Pfizer

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 Timeline

• Study First Submitted: 2007-07-27
• Study First Submitted QC: 2007-07-27
• Study First Posted: 2007-07-30
• Study Start: 2007-08
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	Large volume blood draw	All subjects

Primary Outcome Measures

Name	Time	Method
To identify potential serum donors and obtain unit volumes of blood from these donors for use in pneumococcal opsonophagocytic assay development.	8 years

Trial Locations

Locations (1)

Frontage Clinical Services Inc.; 🇺🇸 Secaucus, New Jersey, United States