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

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ClinicalTrials.gov Identifier: NCT00508950
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : August 17, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Healthy Procedure: 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
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.
Study Start Date : August 2007
Primary Completion Date : June 2016
Study Completion Date : June 2016

Arm Intervention/treatment
All subjects
All subjects
Procedure: Large volume blood draw
Large volume blood draw

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

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

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 Posted: July 30, 2007    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016

Keywords provided by Pfizer:
Pneumococcal Conjugate Vaccine