Passive Enhanced Safety Surveillance of Stamaril® Vaccine... | NCT03541694

Studies
Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea

NCT03541694

Sponsor

Sanofi Pasteur, a Sanofi Company

Status

Completed

Last Update Posted

Mar 26, 2019Actual

Enrollment

622Actual

Phase

Not provided

Conditions

Yellow Fever

Interventions

Stamaril®

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 11, 2018Actual

Primary Completion Date

May 30, 2018Actual

Completion Date

May 30, 2018Actual

First Submitted Date

Apr 23, 2018

First Submission Date that Met QC Criteria

May 17, 2018

First Posted Date

May 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2019

Last Update Posted Date

Mar 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

622Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stamaril®	Biological	Routine vaccination with Stamaril yellow fever vaccine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Vaccination with Stamaril® vaccine in routine practice in Korea

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Participants who have been vaccinated against yellow fever with Stamaril® vaccine in Korean yellow fever vaccination centers during the enhanced surveillance period.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Director	Sanofi Pasteur, a Sanofi Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi Pasteur Investigational Site 001		Seoul		04564	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D015004	Yellow Fever

Ancestor Terms

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections

Browse Leaves

Not provided

Browse Branches

Not provided