Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109330
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2005-04-27
Brief Title:
A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase III Observer-blinded Randomised Multi-centre Clinical Study of the Safety Immunogenicity and Consistency of Three Manufacturing Lots of GSK Biologicals Candidate Tdap Vaccine as Compared to a US-licensed Td Vaccine When Given as a Booster Dose to Healthy Adolescents 10-18 Years of Age
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:
This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents 10-18 years of age
Detailed Description:
A combined Tdap Tetanus Diphteria Acellular Pertussis Vaccine Used as a Booster compared to Licensed Td Tetanus and Diphteria vaccine
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