Healthy Clinical Trial
Official title:
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
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