Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00316524
Status:
COMPLETED
Last Update Posted:
2019-03-06
First Post:
2006-04-19
Brief Title:
A Randomized Double-blind Placebo-controlled Study on Immunogenicity and Safety of MVA-BN IMVAMUNE Smallpox Vaccine in Healthy Subjects
Sponsor:
Bavarian Nordic
Organization:
Bavarian Nordic
Study Overview
Official Title:
A Partially Randomized Partially Double-blind Placebo-controlled Phase II Non-inferiority Study to Evaluate Immunogenicity and Safety of One and Two Doses of MVA-BN IMVAMUNE Smallpox Vaccine in 18-55 Year Old Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2019-02
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 primary objective of this study is to evaluate the immune response after a single vaccination of pre-immune subjects compared to two vaccinations in naive subjects
In addition the study further investigates the cardiac safety profile of MVA-BN in a healthy population compared to placebo
In addition the study further investigates the cardiac safety profile of MVA-BN in a healthy population compared to placebo
Detailed Description:
The study consists of 4 groups which receive either MVA-BN once MVA-BN two times MVA-BN followed by placebo or two administrations of placebo
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT No 2005-001781-14 | None | None | None |
| DMID 05-0128 | None | None | None |