Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042094
Status:
COMPLETED
Last Update Posted:
2011-06-30
First Post:
2002-07-23
Brief Title:
Study of Reactogenicity Safety Immunogenicity and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax
Sponsor:
DynPort Vaccine Company LLC A GDIT Company
Organization:
DynPort Vaccine Company LLC A GDIT Company
Study Overview
Official Title:
A Phase 1 Study of Reactogenicity Safety Immunogenicity and Pock Lesion Formation Take Rate of a Cell-Cultured Smallpox Vaccine CCSV Compared to a Calf Lymph Vaccine Dryvax
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
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 study will evaluate the safety and efficacy of both Dryvax and the new cell-cultured vaccine CCSV in a comparative fashion Across 3 cohorts 150 vaccinia-naive volunteers will be randomly assigned to receive either CCSV 100 volunteers or Dryvax 50 volunteers in a blinded fashion Subjects will be followed closely for up to 6 months and a subgroup of volunteers will be followed up to 3 years in order to evaluate the duration of immunity following vaccination Another cohort will enroll 100 vaccinia-experienced volunteers and randomly assign them to receive either CCSV 50 volunteers or Dryvax 50 volunteers and a sub group will be followed up to 3 years A fifth cohort will enroll 100 vaccinia-naive volunteers and randomly assign them to receive different dilutions of CCSV 11 15 125 and 150
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