Ignite Creation Date:
2024-05-06 @ 12:20 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01551537
Status:
WITHDRAWN
Last Update Posted:
2013-09-09
First Post:
2012-03-08
Brief Title:
Post-marketing Surveillance of GSK Biologicals Cervarix When Administered to Healthy Females in Sri Lanka
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Post-marketing Surveillance PMS of GlaxoSmithKline GSK Biologicals Human Papillomavirus HPV -1618 Vaccine Cervarix When Administered to Healthy Females 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WITHDRAWN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 Cervarix in the local population as per the licensing requirement of the Sri Lankan regulatory authority
Detailed Description:
Subjects who received one or two doses of Cervarix prior to the start of this PMS study can also be enrolled in the study These subjects would receive either 2 doses or 1 dose respectively after being enrolled in the study
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