A Study to Assess the Safety of Adacel® Vaccine
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|ClinicalTrials.gov Identifier: NCT01040052|
Recruitment Status : Completed
First Posted : December 25, 2009
Results First Posted : March 29, 2011
Last Update Posted : May 16, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Diphtheria Tetanus Pertussis||Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Bridging Study to Assess the Safety of the Vaccine Adacel® in a Clinical Trial|
|Study Start Date :||December 2009|
|Primary Completion Date :||February 2010|
|Study Completion Date :||April 2010|
|Experimental: Study Group||
Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
0.5 mL, Intramuscular
Other Name: Adacel®
- 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 learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040052
|Viet Tri, Phu Tho Province, Vietnam|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|