Ignite Creation Date:
2024-05-06 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01803425
Status:
WITHDRAWN
Last Update Posted:
2013-09-09
First Post:
2013-02-28
Brief Title:
Post-marketing Safety Study of GlaxoSmithKline GSK Biologicals Synflorix Vaccine in Healthy Infants and Children in Sri Lanka
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Post-marketing Surveillance PMS of GlaxoSmithKline Biologicals 10-valent Pneumococcal Conjugate Vaccine Synflorix When Administered to Healthy Infants and Children According to the Prescribing Information in Sri Lanka
Status:
WITHDRAWN
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of clarity regarding the PMS study requirement from the RA and Ethics committee hence it was concluded GSK will submit local PSURs
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This PMS study aims to collect safety and reactogenicity data of Synflorix in healthy infants and children of the local population as per the licensing requirement of the Sri Lankan regulatory authority
Detailed Description:
The participating physicians investigators will be asked to enrol only those subjects to whom they administer Synflorix in the course of their normal clinical practice according to the locally approved Prescribing Information
Since there is lack of clarity regarding the PMS study requirement both from Regulatory agency and Ethics Committee it was decided that GSK will submit Local PSURs on a regular basis as desired by Local regulatory agency The same is communicated to Regulatory agency and if they want something more they are requested to revert back with specific requirements
Since there is lack of clarity regarding the PMS study requirement both from Regulatory agency and Ethics Committee it was decided that GSK will submit Local PSURs on a regular basis as desired by Local regulatory agency The same is communicated to Regulatory agency and if they want something more they are requested to revert back with specific requirements
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