A Study to Assess the Safety of Adacel® Vaccine

Sanofi

Status and phase

Completed

Phase 3

Conditions

Diphtheria

Pertussis

Tetanus

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01040052

TD532

U1111-1111-6093 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.