Ignite Creation Date:
2025-12-18 @ 7:56 AM
Ignite Modification Date:
2025-12-18 @ 7:56 AM
Study NCT ID:
NCT00757770
Status:
None
Last Update Posted:
2016-09-07 00:00:00
First Post:
2008-09-22 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine
Sponsor:
None
Organization:
Study Overview
Official Title:
Study to Assess the Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine in Terms of Immunogenicity and Safety When Given to Healthy Infants at 2 and 4 Months of Age
Status:
None
Status Verified Date:
2016-09
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:
The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.
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?: