Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263653
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2005-12-08
Brief Title:
Safety Reactogenicity Immunogenicity Study to Evaluate a Booster Dose of GSK Biologicals Hib-MenC Given With Priorix in Toddlers 13-14 m Primed With 3 Doses of Hib and MenC-CRM197
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Study to Evaluate the Safety Reactogenicity Immunogenicity of a Booster Dose of GSK Biologicals Hib-MenC Given With Priorix vs Hib-MenC or Priorix Only in Toddlers 13-14 m Primed With 3 Doses of Hib as Part of a DTPa -Containing Vaccine MenC-CRM197 Conjugate Vaccines
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:
The purpose of this study is to evaluate the safety reactogenicity and immunogenicity of a booster dose of the candidate Hib-MenC conjugate vaccine given concomitantly with measles mumps and rubella MMR vaccine versus Hib-MenC only and MMR only when given to healthy subjects aged 13 to 14 months who were primed with 3 doses of Hib as part of a DTPa -containing vaccine and MenC-CRM197
Detailed Description:
This multicenter study is open with respect to the treatment allocation but double-blind with respect to the Hib-MenC-TT lots 3 lots Hib-MenC-TT and Priorix when given separately serve as active controls Two blood samples are taken before and one month after vaccination Additional vaccines are offered at study end in order to complete the vaccine schedule recommended in Spain
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