Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146835
Status:
COMPLETED
Last Update Posted:
2014-01-13
First Post:
2005-09-06
Brief Title:
Post-marketing Safety Study of GSK Biologicals Pediarix Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Phase IV Prospective Study of the Safety of GSK Bios Pediarix Administered to a Cohort of Infants in a US Health Maintenance Organization HMO Post-Marketing PEDIARIX Safety Study
Status:
COMPLETED
Status Verified Date:
2014-01
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:
Pre-licensure studies of GSK Biologicals PEDIARIX vaccine have shown it to be generally safe and unlikely to result in vaccine-associated serious adverse events This post-licensure study is designed to evaluate relatively uncommonrare outcomes in a large population cohort
Detailed Description:
The outcomes to be assessed include the occurrence of all seizures with or without fever medically-attended fever seizures associated with fever allergic reactions outpatient visits and hospitalizations for any cause and all deaths
Data collection through utilization of automated databases at the study site with subset medical record review The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Data collection through utilization of automated databases at the study site with subset medical record review The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
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