Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158808
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2005-09-08
Brief Title:
Immune Memory Foll Pry Vaccination With DTPw-HBVHib Vaccine Formulation Immuno Reacto of Booster Dose at 15-18 Mths
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Assess the Immunogenicity d Reactogenicity of a Booster Dose of a Formulation of GSK Biologicals DTPw-HBVHib Vaccine at 15-18 Mths of Age in Infants Previously Primed With the Same Vaccine
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 anti-PRP antibody response one month after vaccination in the groups receiving a fourth consecutive dose of two formulations of DTPw-HBVHib vaccine
Detailed Description:
All subjects were previously primed with one of the two formulations of the combined DTPw-HBVHib vaccine At the age of 10 months 50 of each group received a plain PRP challenge to assess the immune memory to PRP In this booster study in the second year of life all subjects who received DTPw-HBVHib and plain PRP will receive DTPw-HBV as a booster vaccination All other subjects will receive as booster the same vaccine they received in the primary vaccination 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