A Study to Assess the Safety of Adacel® Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01040052
Recruitment Status : Completed
First Posted : December 25, 2009
Results First Posted : March 29, 2011
Last Update Posted : May 16, 2016
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

December 21, 2009
December 25, 2009
March 1, 2011
March 29, 2011
May 16, 2016
December 2009
February 2010   (Final data collection date for primary outcome measure)
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine [ Time Frame: Days 0-7 Post-vaccination ]
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).
To describe the safety profile in terms of solicited injection site and systemic reactions and serious adverse events after booster administration of Adacel vaccine. [ Time Frame: 30 Days post-vaccination ]
Complete list of historical versions of study NCT01040052 on Archive Site
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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.

Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Diphtheria
  • Tetanus
  • Pertussis
Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
0.5 mL, Intramuscular
Other Name: Adacel®
Experimental: Study Group
Intervention: Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2010
February 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
U1111-1111-6093 ( Other Identifier: WHO )
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Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
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Study Director: Medical Director Sanofi Pasteur Inc.
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP