Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381615
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2006-09-27
Brief Title:
Prevention Randomized Open Label Active Control Parallel Assignment SafetyEfficacy Study
Sponsor:
Novartis Vaccines
Organization:
Novartis
Study Overview
Official Title:
A Phase 2 Open Label Multi-Center Controlled Randomized Study of the Safety Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant VaccineOMV When Administered to Healthy Infants at 2 4 6 andor 12 Months of Age
Status:
COMPLETED
Status Verified Date:
2015-09
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:
This study was aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants
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