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

NCT ID: NCT04170140

Last Updated: 2023-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-07

Study Completion Date

2020-03-05

Brief Summary

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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.

Detailed Description

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

Conditions

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Dengue Virus Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Prescribers of Dengvaxia

Healthcare professionals who are current or past prescribers of Dengvaxia

No intervention

Intervention Type OTHER

Questionnaire

Interventions

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No intervention

Questionnaire

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi Pasteur, a Sanofi Company

Locations

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Real World Evidence Solutions IQVIA

La Defense, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 35505623 (View on PubMed)

Other Identifiers

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U1111-1233-9599

Identifier Type: OTHER

Identifier Source: secondary_id

DNG00042

Identifier Type: -

Identifier Source: org_study_id

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