A Study to Assess the Safety of Adacel® Vaccine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tetanus, Diphtheria, Pertussis

Intervention / Treatment
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* Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br> | Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)<br>* 0.5 mL, Intramuscular<br>* Other names: Adacel®;|

What is the study measuring?
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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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tetanus, Diphtheria, Pertussis, Adacel®