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Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00500032
First received: July 11, 2007
Last updated: September 15, 2009
Last verified: September 2009

July 11, 2007
September 15, 2009
March 2007
August 2008   (final data collection date for primary outcome measure)
Primary objective is to obtain blood volumes (approximately 200 to 470 mL per bleed) from volunteer donors who previously completed study 6108A1-500, for use in serological assay development. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Primary objective is to obtain blood volumes (approximately 200 to 470 mL per bleed) from volunteer donors
  • who previously completed study 6108A1-500, for use in serological assay development.
Complete list of historical versions of study NCT00500032 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers
Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers Who Completed Study 6108A1-500

Subjects who have completed study 6108A1-500, in which our experimental meningoccal B vaccine or placebo was administered, will be approached for inclusion into this study which is purely for blood draw. The sera will be used for assay development.

The purpose of this protocol is to analyze the collection of blood volumes (approximately 200 to 470 mL per bleed) from volunteer donors who previously completed study 6108A1-500. As such, the inclusion and exclusion criteria are consistent with the Australian Red Cross guidelines for blood donation.

The 6108A1-500 study is an ongoing, double-blind, ascending-dose, randomized, placebo-controlled trial to assess the safety and tolerability of ascending doses of rLP2086 with aluminum phosphate (AlPO4) adjuvant, in healthy adults aged 18 to 25 years. Upon completion of participation in the 6108A1-500 study, subjects will be approached to participate in this blood sampling study. The sites participating in this blood sampling study are the same sites participating in the 6108A1-500 study.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Healthy
Procedure: blood draw
Blood draw from subjects previously vaccinated in 6108A1-500 trial
Experimental: Arm 1
Active Comparator for all subjects enrolled in 6108A1-500
Intervention: Procedure: blood draw
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
August 2008
August 2008   (final data collection date for primary outcome measure)

Main Inclusion Criteria:

  1. Completed study 6108A1-500.
  2. Hemoglobin level ≥12.0 and ≤16.5 g/dL for female subjects and ≥13.0 and ≤18.5 g/dL for male subjects.
  3. Body weight ≥45 and ≤120 kg.
  4. Systolic blood pressure >90 and <180 mm Hg.
  5. Diastolic blood pressure >60 and <100 mm Hg.
  6. Able to be contacted by telephone.
  7. For all female subjects: have a negative urine pregnancy test unless the subject is surgically sterile.

Main Exclusion Criteria:

  1. Bleeding diathesis or condition associated with prolonged bleeding time.
  2. Prior antibiotic use (within 14 days).
  3. Any clinically significant chronic disease that, in the investigator's judgment may be worsened by blood draw.
Both
18 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00500032
6108A1-1000
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Australia: medinfo@wyeth.com
Wyeth is now a wholly owned subsidiary of Pfizer
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP