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Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03541694
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( 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.

Condition or disease Intervention/treatment
Yellow Fever Biological: Stamaril®

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

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Study Type : Observational
Actual Enrollment : 622 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Passive Enhanced Safety Surveillance of the Live Attenuated Yellow Fever Virus Vaccine Stamaril® in Korea
Actual Study Start Date : April 11, 2018
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Drug Information available for: Stamaril


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


Primary Outcome Measures :
  1. Number of participants reporting suspected related adverse events [ Time Frame: Within 30 days after vaccination ]
    Spontaneous reporting of suspected related adverse events


Secondary Outcome Measures :
  1. Number of participants reporting suspected serious related adverse events [ Time Frame: Within 30 days after vaccination ]
    Spontaneous reporting of serious suspected related adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria
Vaccination with Stamaril® vaccine in routine practice in Korea

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541694


Locations
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Korea, Republic of
Sanofi Pasteur Investigational Site 001
Seoul, Korea, Republic of, 04564
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur, a Sanofi Company

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03541694     History of Changes
Other Study ID Numbers: STA10
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Yellow fever
Stamaril®
Additional relevant MeSH terms:
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Yellow Fever
Fever
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Vaccines
Immunologic Factors
Physiological Effects of Drugs