A Study to Assess the Safety of Adacel® Vaccine
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.
To monitor the adverse effects of the vaccine ADACEL® from day 0 to day 30 after immunization.
|Diphtheria Tetanus Pertussis||Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||A Bridging Study to Assess the Safety of the Vaccine Adacel® in a Clinical Trial|
- 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).
|Study Start Date:||December 2009|
|Study Completion Date:||April 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
|Experimental: Study Group||
Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
0.5 mL, Intramuscular
Other Name: Adacel®
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040052
|Viet Tri, Phu Tho Province, Vietnam|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|