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Immunogenicity and Safety of Adacel Polio Vaccine

NCT00797511 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2012-11-26

Study results available
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Summary

The present study is designed to meet the requirements of the Taiwanese Health Authorities for registration of ADACEL POLIO in Taiwan.

Subjects will receive one dose of the study vaccine at 6 to 8 years of age. Blood samples will be taken for antibody titration. The expected total duration of follow-up for each subject will be 28 days.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis
  • Poliomyelitis

Interventions

BIOLOGICAL

TdcP-IPV vaccine

0.5 mL, Intramuscular

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-04-30
Completion
2009-07-31

Countries

  • Taiwan

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Entities

Companies

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 NCT00797511 on ClinicalTrials.gov