Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325143
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2006-02-08
Brief Title:
Safety of DTPa-IPVHib DTPa-HBV-IPVHib Followed by DTPa-IPVHib Vaccine in Infants Who Received Hepatitis B Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Assess Safety Reactogenicity of DTPa-IPVHib Vaccine Admnd at 3 4 Mths DTPa-HBV-IPVHib Vaccine Admnd at 5 Mths Followed by DTPa-IPVHib Vaccine at 18 Mths in Infants Who Received hepatitisB Vaccine at Birth at One Month of Age
Status:
COMPLETED
Status Verified Date:
2018-05
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:
To assess the safety and reactogenicity of the DTPa-HBV-IPVHib vaccine and DTPa-IPVHib vaccine This DTPa-IPVHib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals rotavirus vaccine or Placebo The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
Single group study Subjects in GSK Biologicals rotavirus study Rota-028 in Singapore will be enrolled in this study
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