An observational study in Dengue Fever and Dengue Hemorrhagic Fever, sponsored by Sanofi Pasteur, a Sanofi Company. Completed. Open to participants aged 9 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Observational
The aim of this study is to evaluate the safety profile of Dengvaxia® when used in the real-world immunization setting
Primary Objective:
Secondary objectives:
This is a prospective multi-national non-interventional study that includes two components of Cohort Event Monitoring (i) Short-term safety surveillance with a follow-up of 6 months after each Dengvaxia® dose administration and (ii) a long-term safety surveillance with a follow-up of five years after the first dose.
No vaccine will be provided as part of this study.
Study population will be identified in a convenient sample of sites as representative as possible of vaccination centers in each country. Subjects who received their first dose of Dengvaxia® at participating sites during the recruitment period and who meet the eligibility criteria will be asked to participate. After enrollment, vaccinees will be contacted periodically by telephone, e-mail, or Short Message Service (SMS) during follow-up for the identification of outcomes and Dengvaxia® vaccination status.
284 studies on the registry are indexed under Dengue; 44 are open to participants now.
This study's enrollment of 30,000 is above the median of 600 across 79 observational studies indexed under Dengue.
Browse Dengue studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
First submitted after Sanofi Pasteur became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
Study population will be identified in a convenient sample of sites as representative as possible of vaccination centers in each country. Subjects who received their first dose of Dengvaxia® across all age groups at participating sites during the recruitment period and who meet the eligibility criteria will be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Percentage of subjects with selected adverse events leading to a medical consultation, emergency room visit or hospitalization occurring during the short term surveillance period of 6 months after each dose of Dengvaxia®
Time frame: 6 months post-vaccination
Percentage of subjects hospitalized with dengue disease (regardless of severity and laboratory confirmation of diagnosis) after each dose of Dengvaxia®.
Time frame: 6 months post-vaccination
Percentage of subjects with any other serious adverse events (SAEs) occurring during the short term surveillance, and SAEs leading to hospitalization or death occurring during the long term surveillance
Time frame: Up to 5 years post-vaccination
No study locations are listed for this record.
Plan to share: 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
Ran from Dec 2016 to primary completion in Dec 2022, 72 months.
Of 36 observational studies under Dengue, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 71. This study's 72 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company →