Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea
Completed
- Conditions
- Yellow Fever
- Registration Number
- NCT03541694
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
This is a passive enhance safety surveillance (ESS) of Stamaril® vaccine in Korea. The objective is to collect suspected related adverse events following vaccination with Stamaril® in routine practice.
- Detailed Description
This ESS replaces the routing post-marketing surveillance required after product approval in Korea.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 622
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants reporting suspected related adverse events Within 30 days after vaccination Spontaneous reporting of suspected related adverse events
- Secondary Outcome Measures
Name Time Method Number of participants reporting suspected serious related adverse events Within 30 days after vaccination Spontaneous reporting of serious suspected related adverse events
Trial Locations
- Locations (1)
Sanofi Pasteur Investigational Site 001
🇰🇷Seoul, Korea, Republic of