A Study to Assess the Safety of Adacel® Vaccine
- Conditions
- TetanusDiphtheriaPertussis
- Interventions
- Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
- Registration Number
- NCT01040052
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study Group Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis) -
- Primary Outcome Measures
Name Time Method Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine 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).
- Secondary Outcome Measures
Name Time Method