MedTrace Logo

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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1440

Last updated 2015-05-19

No results posted yet for this study

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

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis

Interventions

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-02-28
Completion
2015-04-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01993173 on ClinicalTrials.gov