drugset / Trial / NCT01294605

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

NCT01294605

Phase 4 Completed 460 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2003-04
Primary completion
2004-09
Completion
2004-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Boostrix Vaccine Intramuscular
Subject Boostrix-IPV Vaccine Intramuscular
Comparator Ditanrix™ Adult Vaccine Intramuscular
Comparator TedivaxTM Vaccine Intramuscular

Indications