Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT01294605
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2011-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Double-blind, Randomized, Phase III Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of Three Consecutive Doses of dTpa, or of dTpa-IPV Followed by Two Doses of Td Vaccine , and Compared to Three Consecutive Doses of Td Vaccine Administered to Healthy Adults in a 0,1,6-month Schedule
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 purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: