NCT03541694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
622

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

March 26, 2019

Status Verified

July 1, 2018

Enrollment Period

2 months

First QC Date

April 23, 2018

Last Update Submit

March 25, 2019

Conditions

Yellow Fever

Keywords

Yellow feverStamaril®

Outcome Measures

Primary Outcomes (1)

  • Number of participants reporting suspected related adverse events

    Spontaneous reporting of suspected related adverse events

    Within 30 days after vaccination

Secondary Outcomes (1)

  • Number of participants reporting suspected serious related adverse events

    Within 30 days after vaccination

Interventions

Stamaril®BIOLOGICAL

Routine vaccination with Stamaril yellow fever vaccine

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Vaccination with Stamaril® vaccine in routine practice in Korea

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sanofi Pasteur Investigational Site 001

Seoul, 04564, South Korea

Location

MeSH Terms

Conditions

Yellow Fever

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Medical Director

    Sanofi Pasteur, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 30, 2018

Study Start

April 11, 2018

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

March 26, 2019

Record last verified: 2018-07

Locations

KR(1)