NCT01294605

Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acellular Pertussis
• Tetanus
• Diphtheria

Interventions

Type	Name	Description
BIOLOGICAL	Boostrix™ (dTpa)	Intramuscular, 3 doses
BIOLOGICAL	GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)	Intramuscular, single dose
BIOLOGICAL	Ditanrix™ Adult, TedivaxTM (Td)	Intramuscular, 2 doses
BIOLOGICAL	Ditanrix™ Adult, TedivaxTM (Td)	Intramuscular, 3 doses

Timeline

• Start date: 2003-04-01
• Primary completion: 2004-09-01
• Completion: 2004-09-01
• First posted: 2011-02-11
• Last updated: 2016-09-15

Locations

13 sites across 3 countries: Belgium, Netherlands, Spain