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

This study is currently recruiting participants.
Verified April 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00508950
First received: July 27, 2007
Last updated: April 11, 2014
Last verified: April 2014
  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: April 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
Vaccines
Pneumococcal Conjugate Vaccine
Adult

ClinicalTrials.gov processed this record on April 17, 2014