Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320463
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2006-02-21
Brief Title:
Compare Immunogenicity Safety of 2 Formulations of GSK Biologicals DTPa-HBV-IPVHib Vaccine Given in Healthy Infants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Compare Immunogenicity Reactogenicity of 2 Formulations of GSK Biologicals DTPa-HBV-IPVHib Vaccine New vs Current Given in Healthy Infants The DTPa-HBV-IPV Vaccine New Formulation Will Also be Assessed in a 3rd Group of Subjects
Status:
COMPLETED
Status Verified Date:
2016-10
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:
In this study infants will be randomly allocated into three groups
one group of subjects will receive DTPa-HBV-IPVHib vaccine new formulation
the second group of subjects will receive DTPa-HBV-IPVHib vaccine current formulation
the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPVHib vaccine new or current formulation The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine
one group of subjects will receive DTPa-HBV-IPVHib vaccine new formulation
the second group of subjects will receive DTPa-HBV-IPVHib vaccine current formulation
the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPVHib vaccine new or current formulation The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine
Detailed Description:
A study to compare the immunogenicity safety of 2 formulations of GlaxoSmithKline GSK Biologicals DTPa-HBV-IPVHib vaccine given in healthy infants at 34 5 months age The immunogenicity safety of DTPa-HBV-IPV vaccine will also be evaluated in a 3rd group of subjects Subjects in the group that will receive DTPa-HBV-IPVHib vaccine current formulation will be the control group for the group that will receive DTPa-HBV-IPVHib vaccine new formulation
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