Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 6:08 AM
Study NCT ID:
NCT01457560
Status:
COMPLETED
Last Update Posted:
2016-08-05
First Post:
2011-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Mixed With Hib Vaccine in Healthy Infants, Followed by a Dose of the Same Vaccine Administered Simultaneously With One Dose of Oral Polio Vaccine (OPV)
Status:
COMPLETED
Status Verified Date:
2016-08
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 will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: