Ignite Creation Date:
2024-05-05 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00779779
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2008-10-23
Brief Title:
Evaluation of Reactogenicity and Safety of GSK Biologicals Rotarix Human Rotavirus Vaccine in Infants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Reactogenicity and Safety of Two Doses of GSK Biologicals Oral Live Attenuated Human Rotavirus Vaccine Rotarix When Administered in Sri Lankan Infants Aged at Least 6 Weeks at the Time of First Vaccination
Status:
COMPLETED
Status Verified Date:
2011-02
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:
This Post Marketing Surveillance PMS will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks first dose to not more than 24 weeks second dose
Detailed Description:
None
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