Clinical trial NCT02948933: Cohort Event Monitoring for Dengvaxia®, CYD-TDV Dengue Vaccine
Official title: Post-Authorization Safety Study: Cohort Event Monitoring for Dengvaxia®, CYD-TDV Dengue Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dengue Fever
Dengue Hemorrhagic Fever
Keywords: Dengue Fever
Dengue Hemorrhagic Fever
Dengvaxia®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-10-31
Enrollment: 30000
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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®
timeFrame: 6 months post-vaccination
measure: Percentage of subjects hospitalized with dengue disease (regardless of severity and laboratory confirmation of diagnosis) after each dose of Dengvaxia®.
timeFrame: 6 months post-vaccination
measure: 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
timeFrame: Up to 5 years post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi Pasteur Ltd.
name: Medical Director
role: STUDY_DIRECTOR
References: