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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00508950
First Posted: July 30, 2007
Last Update Posted: August 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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
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 ]

Enrollment: 152
Study Start Date: August 2007
Study Completion Date: June 2016
Primary Completion Date: June 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508950


Locations
United States, New Jersey
Frontage Clinical Services Inc.
Secaucus, New Jersey, United States, 07094
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00508950     History of Changes
Other Study ID Numbers: 6115A1-1000
B1851075 ( Other Identifier: Alias Study Number )
First Submitted: July 27, 2007
First Posted: July 30, 2007
Last Update Posted: August 17, 2016
Last Verified: August 2016

Keywords provided by Pfizer:
Vaccines
Pneumococcal Conjugate Vaccine
Adult