Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290329
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2006-02-10
Brief Title:
Safety of Purified Meningococcal Vaccine With Serogroups ACWY in 3000 Filipino Subjects Aged 2 Years
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Multicentric Surveillance Study to Monitor Safety of GSK Biologicals Purified Meningococcal Polysaccharide Vaccine of Serogroups ACWY in 3000 Filipino Subjects Aged Above 2 Years When Administered According to the Prescribing Information
Status:
COMPLETED
Status Verified Date:
2017-01
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:
GlaxoSmithKline Philippines has submitted a registration file for its Purified Meningococcal Polysaccharide of Serogroup ACWY Vaccine Mencevax ACWY This study is being conducted to collect clinical data in the local target population in order to assess the occurrence of rare adverse events after vaccination as per the requirement of Philippines Bureau of Food and Drugs Directive
Detailed Description:
All subjects will receive a single dose of GSK Biologicals Mencevax ACWY vaccine according to the prescribing information Subjects will be stratified into the following age groups
2 to 5 years 6 to 17 years 18 years The Protocol Posting has been updated in order to comply with the FDA Amendment Act September 2007
2 to 5 years 6 to 17 years 18 years The Protocol Posting has been updated in order to comply with the FDA Amendment Act September 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