Clinical trial NCT01040052: A Study to Assess the Safety of Adacel® Vaccine
Official title: A Bridging Study to Assess the Safety of the Vaccine Adacel® in a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Keywords: Diphtheria
Tetanus
Pertussis
Adacel®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-12-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
timeFrame: Days 0-7 Post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Viet Tri
country: Vietnam
state: Phu Tho Province
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: