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

NCT02948933 | Completed

• 3 other identifiers: DNG15U1111-1143-8608EUPAS28947
• Study Type: observational
• Target: 30,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dengue Fever; Dengue Hemorrhagic Fever

Keywords

Dengue Fever; Dengue Hemorrhagic Fever; Dengvaxia®

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Related Links

• Related Info

MeSH Terms

Conditions

Dengue; Severe Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Medical Director

  Sanofi Pasteur Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: October 31, 2016
• Study Start: December 14, 2016
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share