Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Pfizer
Information provided by (Responsible Party):
Pfizer Identifier:
First received: July 27, 2007
Last updated: February 6, 2015
Last verified: February 2015

The study will identify healthy adults who have been vaccinated against pneumococcus, and collect blood for the purpose of developing laboratory assays.

Condition Intervention
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 Pneumococcal 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: August 2007
Estimated Study Completion Date: December 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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00508950

Contact: Pfizer Call Center 1-800-718-1021

United States, New Jersey
Advanced Biomedical Research, Inc. Recruiting
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT00508950     History of Changes
Other Study ID Numbers: 6115A1-1000, B1851075
Study First Received: July 27, 2007
Last Updated: February 6, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
Pneumococcal Conjugate Vaccine
Adult processed this record on March 03, 2015