A Study to Assess the Safety of Adacel® Vaccine

April 12, 2016 updated by: Sanofi Pasteur, a Sanofi Company

A Bridging Study to Assess the Safety of the Vaccine Adacel® in a Clinical Trial

The objective of this study is to describe the safety of Adacel® vaccination in adults subjects in Vietnam. This study is conducted in accordance with Vietnamese regulation in support to Adacel® registration.

Primary objective:

To monitor the adverse effects of the vaccine ADACEL® from day 0 to day 30 after immunization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will receive a single dose of Adacel® vaccine and will be followed closely during 30 minutes post-vaccination period; a home visit will be made daily during 7 days following vaccination in order to monitor safety.

An additional visit will be conducted 30 days post-vaccination to collect safety information.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Phu Tho Province
      • Viet Tri, Phu Tho Province, Vietnam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • Male or female (not pregnant) from 18-45 years of age.
  • Healthy, with no current illnesses.
  • Have not been immunized against diphtheria, pertussis and tetanus in the past 5 years.
  • Women of childbearing age will agree to use birth control during the study.
  • In good health, as verified by the following criteria: Heart rate, blood pressure, temperature and health history.
  • Able to understand and comply with requirements of the study.
  • A voluntary consent form is required before participating in the study.

Exclusion Criteria :

  • History of allergy to any ingredient in the vaccine.
  • A positive pregnancy test (for women of childbearing age) or women who are breastfeeding.
  • Compromised immune system due to treatment of a progressive disease.
  • Currently on oral or injected steroids, inhaled high-dosage steroids or other immunodeficiency or toxic drugs.
  • History of taking Immunoglobulin or other products during the 3 months prior to participating in the study.
  • Received other vaccines during the 4 months prior to participating in the study.
  • Has an acute or chronic condition that affects safety (including but not limited to: chronic liver disease, some kidney pathologies, progressive or unstabilized nerve disorders, diabetes and organ transplants).
  • Experienced a severe adverse event after receiving ADACEL® vaccine.
  • History of acute illness with temperatures over 37.5ºC during the week before receiving the vaccine.
  • Human immunodeficiency virus (HIV) infection.
  • History of alcohol or drug addiction during the past 5 years.
  • Plans to travel outside of the study area between shots and visits.
  • History of Guillain-Barré syndrome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
0.5 mL, Intramuscular
Other Names:
  • Adacel®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Time Frame: Days 0-7 Post-vaccination
Solicited injection site reactions: Pain, itchiness, erythema (redness), and swelling. Solicited systemic reactions: Headache, body ache and muscle weakness, tiredness, chill, nausea, vomiting, rash, itchiness, anorexia, sore and swollen joints, diarrhea, lymph node swelling, and fever (temperature).
Days 0-7 Post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

December 24, 2009

First Posted (Estimate)

December 25, 2009

Study Record Updates

Last Update Posted (Estimate)

May 16, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD532
  • U1111-1111-6093 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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