Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103584
Status:
UNKNOWN
Last Update Posted:
2007-01-15
First Post:
2005-02-10
Brief Title:
Safety and Immunogenicity Study of LC16m8 a Modified Smallpox Vaccine in Healthy Previously Unvaccinated Volunteers
Sponsor:
VaxGen
Organization:
VaxGen
Study Overview
Official Title:
A Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of LC16m8 A Modified Vaccinia Vaccine in Healthy Volunteers
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase III study evaluating the safety and immunogenicity of LC16m8 a modified vaccinia vaccine After consent and thorough screening including safety labs EKG and medical history healthy previously unvaccinated volunteers between the ages of 18-34 will receive a single vaccination of either LC16m8 or the current US-licensed smallpox vaccine Dryvax Volunteers will be blindly randomized to a treatment group in a 41 ratio 4 LC16m8 to 1 Dryvax recipient Follow-up clinical evaluations laboratory testing EKGs and cardiac assessments will be done at regularly scheduled follow-up visits for 1 year after vaccination
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