Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169442
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2005-09-12
Brief Title:
Immune Memory of DTPw-HBVHib Vaccine Following Primary Vaccination Immuno Reacto of a Booster Dose Given in Infants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Immune Memory of GSKs DTPw-HBVHib Vaccine by Giving Plain PRP Polysaccharide at 10 Mths Immuno Reacto of a Booster Dose of DTPw-HBVHib or DTPw-HBV or DTPw-HBVHib at 15-18 Mths in Infants Previously Primed With DTPw-HBVHib
Status:
COMPLETED
Status Verified Date:
2017-05
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 immune memory following primary vaccination of DTPw-HBVHib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age
Detailed Description:
Subjects who received DTPw-HBVHib in the primary vaccination without HBV at birth will be randomised 13 ratio to receive either Plain PRP at 10 months of age followed by DTPw-HBV at 15-18 months of age or DTPw-HBVHib at 15-18 months of age
Subjects who received DTPw-HBV Hib in the primary vaccination without HBV at birth will receive DTPw-HBV Hib as a booster
Subjects who received DTPw-HBVHib in the primary vaccination with HBV at birth will receive DTPw-HBVHib vaccine as a booster
Subjects who received DTPw-HBV Hib in the primary vaccination without HBV at birth will receive DTPw-HBV Hib as a booster
Subjects who received DTPw-HBVHib in the primary vaccination with HBV at birth will receive DTPw-HBVHib vaccine as a booster
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