Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258947
Status:
COMPLETED
Last Update Posted:
2012-02-01
First Post:
2005-11-24
Brief Title:
Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Take Evaluation and Safety of Smallpox Vaccine LISTER Strain in Naïve Healthy Adults
Status:
COMPLETED
Status Verified Date:
2012-01
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:
Primary Objective
To estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine
Secondary Objectives
To describe antibody response to vaccination and evaluate the take for each subject at various timepoints for each batch and pooled batches and to evaluate local signs symptoms and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine
To estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine
Secondary Objectives
To describe antibody response to vaccination and evaluate the take for each subject at various timepoints for each batch and pooled batches and to evaluate local signs symptoms and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine
Detailed Description:
None
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