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

Blood Collection In Healthy Adult Volunteers To Obtain Serum For Use In Serum Bactericidal Activity Assay Development

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: November 17, 2006
Last updated: February 6, 2015
Last verified: February 2015

This is a study to collect blood from volunteers to assist in assay development.

Condition Intervention Phase
Healthy Subjects
Procedure: Blood Collection
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Blood Collection in Healthy Adult Volunteers to Obtain Serum for Use in Serum Bactericidal Activity Assay Development

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • "No outcome measures". Blood collected for assay development. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: August 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Procedure: Blood Collection
Blood Collection


Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy Volunteers aged 18-64

Exclusion Criteria:

  • Bleeding disorder
  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: NCT00401232

United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21201
United States, New Jersey
Pfizer Investigational Site
Hackensack, New Jersey, United States, 07601
United States, New York
Pfizer Investigational Site
Pearl River, New York, United States, 10965
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT00401232     History of Changes
Other Study ID Numbers: 6108A1-800, B1971032
Study First Received: November 17, 2006
Last Updated: February 6, 2015
Health Authority: United States: Institutional Review Board processed this record on March 03, 2015