Brief Title
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Condition
Diphtheria
Intervention
Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
Study Arms / Comparison Groups
Study Group
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
30
Start Date
December 2009
Completion Date
April 2010
Primary Completion Date
February 2010
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.
Gender
All
Ages
18 Years - 45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
Vietnam
Location Countries
Vietnam
Administrative Informations
NCT ID
NCT01040052
Organization ID
TD532
Secondary IDs
U1111-1111-6093
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur Inc.
Verification Date
April 2016