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
  Purpose

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.


Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Bridging Study to Assess the Safety of the Vaccine Adacel® in a Clinical Trial

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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).


Enrollment: 30
Study Start Date: December 2009
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
0.5 mL, Intramuscular
Other Name: Adacel®

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040052

Locations
Vietnam
Viet Tri, Phu Tho Province, Vietnam
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01040052     History of Changes
Other Study ID Numbers: TD532, U1111-1111-6093
Study First Received: December 21, 2009
Results First Received: March 1, 2011
Last Updated: January 10, 2014
Health Authority: Vietnam: Ministry of Health

Keywords provided by Sanofi:
Diphtheria
Tetanus
Pertussis
Adacel®

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014