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NCT03541694 Clinical Trial

Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea

Yellow Fever Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03541694
Other study ID # STA10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 11, 2018
Est. completion date May 30, 2018

Study information
Verified date July 2018
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

This ESS replaces the routing post-marketing surveillance required after product approval in Korea.

Recruitment information / eligibility
Status Completed
Enrollment 622
Est. completion date May 30, 2018
Est. primary completion date May 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Vaccination with Stamaril® vaccine in routine practice in Korea

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Stamaril®
Routine vaccination with Stamaril yellow fever vaccine

Locations
Country Name City State
Korea, Republic of Sanofi Pasteur Investigational Site 001 Seoul

Sponsors (1)
Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants reporting suspected related adverse events Spontaneous reporting of suspected related adverse events Within 30 days after vaccination
Secondary Number of participants reporting suspected serious related adverse events Spontaneous reporting of serious suspected related adverse events Within 30 days after vaccination
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