drugset / Trial / NCT01933776

Study of the Tdap Combined Vaccine (ADACEL™) as a Booster Dose in Healthy Adults and Children in China

NCT01933776

Phase 1 Completed 40 enrolled Sanofi Pasteur, a Sanofi Company
Non-randomizedParallel-groupOpen-labelPrevention

Summary

The aim of the study is to assess the safety profile of ADACEL vaccine in a small number of participants in China. Primary objective: * To describe the safety in terms of occurrence of serious adverse reactions and grade 3 adverse reactions after administration of Sanofi Pasteur's Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children. Secondary objective: * To describe the full reactogenicity profile after administration of sanofi pasteur's Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children.

Timeline

Start
2013-08
Primary completion
2013-11
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject tetanus toxoid Vaccine 0.5 ml Intramuscular