Dengue Fever, Dengue Hemorrhagic Fever
Conditions
Keywords
Dengue Fever, Dengue Hemorrhagic Fever, Dengvaxia®
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Percentage of subjects hospitalized with dengue disease (regardless of severity and laboratory confirmation of diagnosis) after each dose of Dengvaxia®. | 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 | Up to 5 years post-vaccination |
Outcome results
None listed