Cohort Event Monitoring for Dengvaxia®, CYD-TDV Dengue Vaccine

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.

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Key information

Conditions

Dengue Fever Arbovirus Infections Dengue Dengue Hemorrhagic Fever Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Severe Dengue Vector Borne Diseases Virus Diseases

Age range

9 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Post-Authorization Safety Study: Cohort Event Monitoring for Dengvaxia®, CYD-TDV Dengue Vaccine

Important dates

Study start: 2016
Primary completion: 2022
Study completion: 2022
First posted: Oct 31, 2016
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed