Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea

NCT ID: NCT03541694

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

622 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-11

Study Completion Date

2018-05-30

Brief Summary

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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

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

Conditions

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Yellow Fever

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Stamaril®

Routine vaccination with Stamaril yellow fever vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Vaccination with Stamaril® vaccine in routine practice in Korea
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur, a Sanofi Company

Locations

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Sanofi Pasteur Investigational Site 001

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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STA10

Identifier Type: -

Identifier Source: org_study_id

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