Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346073
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2006-06-28
Brief Title:
Safety and Immunogenicity of GSKs Tdap Vaccine Boostrix in Adults Aged 19 to 64 Years
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Study to Evaluate Immunogenicity and Safety of Boostrix Compared to Adacel When Administered as a Booster Vaccination in Adults Aged 19 to 64 Years of Age
Status:
COMPLETED
Status Verified Date:
2018-02
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:
GSK Biologicals dTpa vaccine has recently been approved by the US Food and Drug Administration FDA for booster vaccination of adolescents aged 10 to 18 years The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age
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