Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea

Sanofi Pasteur, a Sanofi Company622 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

622

Conditions

Yellow Fever

Interventions

Stamaril®BIOLOGICAL

Routine vaccination with Stamaril yellow fever vaccine

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Vaccination with Stamaril® vaccine in routine practice in Korea

Locations (1)

Sanofi Pasteur Investigational Site 001

Seoul, South Korea

Outcomes

Primary Outcomes

Number of participants reporting suspected related adverse events

Spontaneous reporting of suspected related adverse events

Time frame: Within 30 days after vaccination

Secondary Outcomes

Number of participants reporting suspected serious related adverse events

Spontaneous reporting of serious suspected related adverse events

Time frame: Within 30 days after vaccination

Data from ClinicalTrials.gov

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