Tetanus Clinical Trial
Official title:
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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