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

Status

Completed

Conditions

Intervention / Treatment

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

      • 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.

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

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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