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.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adacel | Vaccine | 0.5 ml | Intramuscular |
| Comparator | DT vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Td vaccine | Vaccine | 0.5 ml | Intramuscular |