Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1233-9599 | Other Identifier | UTN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The study is a cross-sectional Survey. Study data are collected through a questionnaire.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prescribers of Dengvaxia | Healthcare professionals who are current or past prescribers of Dengvaxia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare professionals' knowledge of Dengvaxia product information | Knowledge of Dengvaxia product information (age indication and contraindications) is assessed through a questionnaire | Day 0 |
Not provided
Inclusion criteria:
- Healthcare professionals who are current or past prescribers of Dengvaxia
Exclusion criteria:
The above information is not intended to contain all considerations relevant to participation in the survey.
Not provided
Not provided
Not provided
Not provided
Healthcare professionals who are current or past prescribers of Dengvaxia
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Real World Evidence Solutions IQVIA | La Defense | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35505623 | Result | 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. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |