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Clinical Trials/NCT03541694
NCT03541694
Completed
Not Applicable

Passive Enhanced Safety Surveillance of the Live Attenuated Yellow Fever Virus Vaccine Stamaril® in Korea

Sanofi Pasteur, a Sanofi Company1 site in 1 country622 target enrollmentApril 11, 2018
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ConditionsYellow Fever

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Yellow Fever
Sponsor
Sanofi Pasteur, a Sanofi Company
Enrollment
622
Locations
1
Primary Endpoint
Number of participants reporting suspected related adverse events
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 11, 2018
End Date
May 30, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of participants reporting suspected related adverse events

Time Frame: Within 30 days after vaccination

Spontaneous reporting of suspected related adverse events

Secondary Outcomes

  • Number of participants reporting suspected serious related adverse events(Within 30 days after vaccination)

Study Sites (1)

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