Dengue Virus InfectionDNG00042NCT04170140
Study on Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update
An observational study of Dengue Virus Infection, run by Sanofi Pasteur, a Sanofi Company at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dengue Virus Infection
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2020to 5 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthcare professionals who are current or past prescribers of Dengvaxia
Who may be able to join
- Healthcare professionals who are current or past prescribers of Dengvaxia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The study is a cross-sectional Survey. Study data are collected through a questionnaire.
- Conditions
- Dengue Virus Infection
- Being tested
- No intervention
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Prescribers of Dengvaxia | Healthcare professionals who are current or past prescribers of Dengvaxia Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Secondary outcomes (1)
Healthcare professionals' knowledge of Dengvaxia product information
Knowledge of Dengvaxia product information (age indication and contraindications) is assessed through a questionnaire
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start7 Jan 2020
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dengue Virus InfectionStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170140
- Sponsor's protocol ID
- DNG00042
- Other IDs
- U1111-1233-9599
- Acronym
- DNG00042
- Status last verified
- Apr 2022
- First submitted
- 18 Nov 2019
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 35505623
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Survey to Evaluate Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update
- ClinicalTrials.gov ID
- NCT04170140
- Acronym / sponsor ID
- DNG00042 / DNG00042
- Conditions
- Dengue Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The study is a cross-sectional Survey. Study data are collected through a questionnaire.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prescribers of Dengvaxia | – | Other: No interventionHealthcare professionals who are current or past prescribers of Dengvaxia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthcare professionals who are current or past prescribers of Dengvaxia
Key inclusion criteria (1 listed)
- Healthcare professionals who are current or past prescribers of Dengvaxia
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionQuestionnaire | Other | Prescribers of Dengvaxia |
Primary outcome
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
1 secondary outcome
Healthcare professionals' knowledge of Dengvaxia product information
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Results publication: PubMed 35505623Almas 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi Pasteur, a Sanofi Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue Virus Infection, run by Sanofi Pasteur, a Sanofi Company at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare professionals' knowledge and understanding of key safety messages provided in risk minimization measures materials (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04170140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.