A Study to Assess the Safety of Adacel® Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01040052
First received: December 21, 2009
Last updated: January 10, 2014
Last verified: January 2014

December 21, 2009
January 10, 2014
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01040052 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Vietnam
 
NCT01040052
TD532, U1111-1111-6093
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
January 2014

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