Dengue Fever Clinical Trial
Official title:
Post-Authorization Safety Study: Cohort Event Monitoring for Dengvaxia®, CYD-TDV Dengue Vaccine
Verified date | January 2023 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this study is to evaluate the safety profile of Dengvaxia® when used in the real-world immunization setting Primary Objective: - To measure the incidence of selected adverse events (AEs) and serious AEs (SAEs) occurring over a period of six (6) months after each Dengvaxia® dose administration; - To quantify the association between Dengvaxia® and each of the selected AEs and SAEs for which a risk window after vaccination can be defined, using estimates of relative risk - To monitor the occurrence and frequency of hospitalized dengue disease as well as any other SAEs leading to hospitalization or death, including new and previously unrecognized SAEs, following Dengvaxia® administration on a longer term (up to 5 years after the first Dengvaxia® dose administration. Secondary objectives: - To identify risk factors for hospitalized dengue disease (severe or not) among subjects vaccinated with Dengvaxia®; - To describe the frequency of hospitalized dengue disease and/or other SAEs or selected AEs according to the number of Dengvaxia® doses and/or interval between doses.
Status | Active, not recruiting |
Enrollment | 30000 |
Est. completion date | July 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years and older |
Eligibility | Inclusion Criteria: - Subjects who received the first dose of Dengvaxia® across all age groups, even if vaccination was given outside of local specific label indications or recommendations - Informed consent form (ICF) or Assent form (AF) has been signed and dated by the subject (based on local regulations), and/or ICF has been signed and dated by the parent(s) or another legal acceptable representative (and by an independent witness if required by local regulations) - Subjects for whom a telephone contact or an e-mail address is available. Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Mexico | Investigational Site 2008-001 | Cuernavaca | |
Mexico | Investigational Site 2011-001 | Guerrero | |
Mexico | Investigational Site 2007-001 | Mérida | |
Mexico | Investigational Site 2001-001 | Mexico | |
Mexico | Investigational Site 2002-001 | Monterrey | |
Mexico | Investigational Site 2003-001 | Puerto Vallarta | |
Mexico | Investigational Site 2004-001 | Veracruz | |
Mexico | Investigational Site 2006-001 | Villahermosa | |
Mexico | Investigational Site 2010-001 | Zapopan |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
Brazil, Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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® | 6 months post-vaccination | ||
Primary | Percentage of subjects hospitalized with dengue disease (regardless of severity and laboratory confirmation of diagnosis) after each dose of Dengvaxia®. | 6 months post-vaccination | ||
Primary | 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 | Up to 5 years post-vaccination |
Status | Clinical Trial | Phase | |
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