Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 10:00 PM
Study NCT ID:
NCT01375933
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2011-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers
Sponsor:
Nabi Biopharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Assess Comparability of a Single Phase 3 Lot and a Single Commercial Lot of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Healthy Adult Smokers
Status:
COMPLETED
Status Verified Date:
2012-05
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:
The purpose of this study is to assess the comparability of the phase 3 lot and a single commercial lot of NicVAX in healthy smokers.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: