Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366366
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2006-08-18
Brief Title:
To Evaluate Immunogenicity Safety of GSK Bios DTPa-HBV-IPVHib Mixed Vaccine and DTPa-IPVHib HBV Vaccines
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Phase III Open Randomised Immunogenicity and Reactogenicity Study to Assess the Interchangeability Between GSK Bios DTPa-HBV-IPVHib and DTPa-IPVHib HBV at 3rd Dose of Primary Vac Course in Children Who Received HBV Vac at Birth and One Month of Age and DTPa-IPVHib Vac at 3-4 Mth of Age
Status:
COMPLETED
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:
This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals combined DTPa-HBV-IPVHib vaccine or DTPa-IPVHib vaccine In the two groups infants received the DTPa-IPVHib vaccine at 3 and 4 months of age as the first 2 doses of the primary vaccination course At 5 months of age they received either the DTPa-IPVHib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPVHib vaccine as a 3rd dose Infants in the two groups had previously received 2 doses of HBV vaccine at birth and at 1 month of age
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