Study on Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update (DNG00042)

September 14, 2023 updated by: Sanofi Pasteur, a Sanofi Company

A Cross-sectional Survey to Evaluate Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update

The primary objective of the study is to evaluate the effectiveness of additional risk minimization measures material by assessing the knowledge and understanding of healthcare professionals regarding the key safety messages provided in the material.

The secondary objective of the study is to evaluate if healthcare professionals know Dengvaxia product information, namely, age indication and contraindications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a cross-sectional Survey. Study data are collected through a questionnaire.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Defense, France
        • Real World Evidence Solutions IQVIA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthcare professionals who are current or past prescribers of Dengvaxia

Description

Inclusion criteria:

- Healthcare professionals who are current or past prescribers of Dengvaxia

Exclusion criteria:

  • Healthcare professionals who have never prescribed Dengvaxia
  • Healthcare professionals who may have a conflict of interest with the survey (i.e. Healthcare professionals employed by regulatory bodies, pharmaceutical industries)
  • Healthcare professionales who have participated in testing the questionnaire for comprehensibility, consistency and the appropriateness of medical terms

The above information is not intended to contain all considerations relevant to participation in the survey.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prescribers of Dengvaxia
Healthcare professionals who are current or past prescribers of Dengvaxia
Other: No intervention
Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare professionals' knowledge and understanding of key safety messages provided in risk minimization measures materials
Time Frame: Day 0
Knowledge and understanding of key safety messages are assessed through a questionnaire
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare professionals' knowledge of Dengvaxia product information
Time Frame: Day 0
Knowledge of Dengvaxia product information (age indication and contraindications) is assessed through a questionnaire
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2020

Primary Completion (Actual)

March 5, 2020

Study Completion (Actual)

March 5, 2020

Study Registration Dates

First Submitted

November 18, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • DNG00042
  • U1111-1233-9599 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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