A Study to Assess the Safety of Adacel® Vaccine

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.

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.

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.