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.

Immunogenicity and Safety of Sanofi Pasteur's Tdap Combined Vaccine (ADACEL) as a Booster Dose, Versus Local DT Vaccine in Healthy Children or Versus Local Td Vaccine in Healthy Adolescents and Adults in China

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,440 (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 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

Detailed description

Study participants will receive a single booster dose of ADACEL (Tdap vaccine) or a single booster dose of local DT or local Td vaccine, depending on the age subgroup. Immunogenicity will be assessed before and 28 days post-vaccination; safety profile will be assessed in all subjects up to Day 35 post vaccination.

Conditions

• Diphtheria
• Tetanus
• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap (ADACEL)	0.5 mL, Intramuscular
BIOLOGICAL	DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed)	0.5 mL, Intramuscular
BIOLOGICAL	Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed)	0.5 mL, Intramuscular

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-02-01
• Completion: 2015-04-01
• First posted: 2013-11-25
• Last updated: 2015-05-19

Locations

1 site across 1 country: China