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

NCT04170140 | Completed

• 2 other identifiers: DNG00042U1111-1233-9599
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dengue Virus Infection

Outcome Measures

Primary Outcomes (1)

• Healthcare professionals' knowledge and understanding of key safety messages provided in risk minimization measures materials

  Knowledge and understanding of key safety messages are assessed through a questionnaire

  Day 0

Secondary Outcomes (1)

• Healthcare professionals' knowledge of Dengvaxia product information

  Day 0

Study Arms (1)

Prescribers of Dengvaxia

Healthcare professionals who are current or past prescribers of Dengvaxia

Other: No intervention

Interventions

No intervention OTHER

Questionnaire

Prescribers of Dengvaxia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthcare professionals who are current or past prescribers of Dengvaxia

You may qualify if:

• \- Healthcare professionals who are current or past prescribers of Dengvaxia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Real World Evidence Solutions IQVIA

La Defense, France

Location

Related Publications (1)

• Almas MF, Toussi M, Valero E, Moureau A, Marcelon L. A cross-sectional survey to evaluate prescribers' knowledge and understanding of safety messages following Dengvaxia(R) product information update. Pharmacoepidemiol Drug Saf. 2022 Jul;31(7):758-768. doi: 10.1002/pds.5447. Epub 2022 May 13.

  PMID: 35505623 RESULT

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: January 7, 2020
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: September 18, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)