drugset / Trial / NCT01993173

Sanofi Pasteur's Tdap Combined Vaccine as a Booster Versus Local DT Vaccine in Children or Versus Local Td Vaccine in Adolescents and Adults in China.

NCT01993173

Phase 3 Completed 1440 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupSingle-blindPrevention

Summary

The aim of the study is to assess the immunogenicity and safety profile of ADACEL compared to local adsorbed diphtheria and tetanus combined vaccine (local DT or local Td vaccine in participants in China. Primary objective: * To describe diphtheria and tetanus seroprotection rates and pertussis booster response rates induced by each of the study vaccines: ADACEL vaccine (in all study age groups), local DT vaccine (in children), and local Td vaccine (in adolescents and adults). Secondary Objectives: * To further describe in each group the immunogenicity of the study vaccines at baseline and 1 month after vaccination. * To describe the safety of the study vaccines

Timeline

Start
2013-11
Primary completion
2014-02
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Adacel Vaccine 0.5 ml Intramuscular
Comparator DT vaccine Vaccine 0.5 ml Intramuscular
Comparator Td vaccine Vaccine 0.5 ml Intramuscular