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Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents

NCT01689324 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2014-02-21

Study results available
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Summary

This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose in adolescents in Japan.

Primary Objective:

* To assess the immunogenicity of Tdap (SP306) when administered as a single dose in Japanese adolescents

Secondary Objective:

* To assess the safety of Tdap vaccine when administered as a single dose in Japanese adolescents.

Conditions

  • Pertussis
  • Tetanus
  • Diphtheria

Interventions

BIOLOGICAL

(ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur K.K

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-11-30
Completion
2013-05-31

Countries

  • Japan

Study Locations

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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 NCT01689324 on ClinicalTrials.gov