Passive Enhanced Safety Surveillance of Stamaril® Vaccine 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.

Completed

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Key information

Conditions

Yellow Fever Arbovirus Infections Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanofi Pasteur Investigational Site 001

Seoul, 04564, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Vaccination with Stamaril® vaccine in routine practice in Korea

Treatment and study plan

Stamaril®

Biological

Routine vaccination with Stamaril yellow fever vaccine

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

Time frame: Within 30 days after vaccination

Spontaneous reporting of serious suspected related adverse events

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: May 30, 2018
Registry last updated: Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed