Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353366
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2006-07-17
Brief Title:
To Evaluate Safety Reactogenicity of GSK Bios Human Rotavirus HRV Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Open Multicentric Post-marketing Surveillance Study to Evaluate Safety and Reactogenicity of GSK Bios Live Attenuated Oral Human Rotavirus HRV Vaccine Rotarix When Administered According to Prescribing Information in Filipino Subjects Aged at Least 6 Weeks of Age at the Time of First Vaccination
Status:
COMPLETED
Status Verified Date:
2021-02
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:
GSK has submitted a registration file for its live attenuated oral human rotavirus HRV vaccine in several countries In view of its registration in the Philippines the present study will collect data on the safety of the vaccine in the local target population as per the Bureau of Food and Drugs Directive
Detailed Description:
The protocol was amended to reflect a change in the prescribing information The age of the infants was changed from 6 - 14 weeks to at least 6 weeks at the time of the first vaccination This protocol posting has been amended in order to comply with FDA AA
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-004039-21 | EUDRACT_NUMBER | None | None |