Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263679
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2005-12-08
Brief Title:
Assessment of GSK Biologicals Tdap Candidate Vaccine Administered as a Booster 6th Dose in Terms of Immunogenicity and Safety to Children and Adolescents Previously Vaccinated With Five Doses of an Acellular Pertussis-containing Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase III Double-blinded Randomized Multicenter Clinical Study to Assess the Safety and Immunogenicity of GSK Biologicals Tdap 03 mg Candidate Vaccine When Given as a Booster Dose to Healthy School Children and Adolescents 9-13 Years of Age Previously Vaccinated With a 5th Consecutive Dose of Acellular Pertussis-containing Vaccine in Studies APV-118 or APV-120
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 aims of this study are to evaluate the safety and immunogenicity of a booster dose of GSK Biologicals candidate Tdap vaccine containing 03 mg Al when administered to healthy school children and adolescents 9-13 years of age previously vaccinated with five consecutive doses of Pa-containing vaccine The inclusion of hepatitis A vaccine Havrix as a control vaccine enables this study to be conducted in a double-blinded in terms of immunogenicity and safety assessments
Detailed Description:
None
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