Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03541694

Enrollment

622

Registered

2018-05-30

Start date

2018-04-11

Completion date

2018-05-30

Last updated

2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Yellow Fever

Keywords

Yellow fever, Stamaril®

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.

Detailed description

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

Interventions

BIOLOGICALStamaril®

Routine vaccination with Stamaril yellow fever vaccine

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

Vaccination with Stamaril® vaccine in routine practice in Korea

Design outcomes

Primary

Measure	Time frame	Description
Number of participants reporting suspected related adverse events	Within 30 days after vaccination	Spontaneous reporting of suspected related adverse events

Secondary

Measure	Time frame	Description
Number of participants reporting suspected serious related adverse events	Within 30 days after vaccination	Spontaneous reporting of serious suspected related adverse events

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026