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Clinical Trial 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.


Clinical Trial Description

Participants will be enrolled sequentially into the study groups to receive one dose of ADACEL at Day 0 (Visit 1) and will be followed-up for 28-35 days. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01933776
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date August 2013
Completion date January 2014

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