Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-03 @ 6:29 AM
Study NCT ID:
NCT02948933
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2016-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Event Monitoring for Dengvaxia®, CYD-TDV Dengue Vaccine
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Post-Authorization Safety Study: Cohort Event Monitoring for Dengvaxia®, CYD-TDV Dengue Vaccine
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: