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

NCT01933776 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-03-07

Study results available
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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.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis

Interventions

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)

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-11-30
Completion
2014-01-31

Countries

  • China

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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 NCT01933776 on ClinicalTrials.gov