- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03541694
Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea
March 25, 2019 updated by: Sanofi Pasteur, a Sanofi Company
Passive Enhanced Safety Surveillance of the Live Attenuated Yellow Fever Virus Vaccine Stamaril® in Korea
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.
Study Overview
Detailed Description
This ESS replaces the routing post-marketing surveillance required after product approval in Korea.
Study Type
Observational
Enrollment (Actual)
622
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 04564
- Sanofi Pasteur Investigational Site 001
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants who have been vaccinated against yellow fever with Stamaril® vaccine in Korean yellow fever vaccination centers during the enhanced surveillance period.
Description
Vaccination with Stamaril® vaccine in routine practice in Korea
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants reporting suspected related adverse events
Time Frame: Within 30 days after vaccination
|
Spontaneous reporting of suspected related adverse events
|
Within 30 days after vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants reporting suspected serious related adverse events
Time Frame: Within 30 days after vaccination
|
Spontaneous reporting of serious suspected related adverse events
|
Within 30 days after vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2018
Primary Completion (Actual)
May 30, 2018
Study Completion (Actual)
May 30, 2018
Study Registration Dates
First Submitted
April 23, 2018
First Submitted That Met QC Criteria
May 17, 2018
First Posted (Actual)
May 30, 2018
Study Record Updates
Last Update Posted (Actual)
March 26, 2019
Last Update Submitted That Met QC Criteria
March 25, 2019
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STA10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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