NCT00500032

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
PROCEDURE	blood draw	Blood draw from subjects previously vaccinated in 6108A1-500 trial

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2007-07-12
• Last updated: 2009-09-16

Locations

3 sites across 1 country: Australia