NCT01933776

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 4 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Diphtheria
• Tetanus
• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap	0.5 mL, Intramuscular (IM)
BIOLOGICAL	Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap	0.5 mL, Intramuscular (IM)

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-11-01
• Completion: 2014-01-01
• First posted: 2013-09-02
• Last updated: 2016-03-07
• Results posted: 2014-04-21

Locations

1 site across 1 country: China