Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500032
Status:
COMPLETED
Last Update Posted:
2009-09-16
First Post:
2007-07-11
Brief Title:
Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers Who Completed Study 6108A1-500
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None