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

NCT ID: NCT02948933

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-14
• Study Completion Date: 2022-12-22

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.

Conditions

Dengue Fever; Dengue Hemorrhagic Fever

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Ltd.

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

U1111-1143-8608

Identifier Type: REGISTRY

Identifier Source: secondary_id

EUPAS28947

Identifier Type: REGISTRY

Identifier Source: secondary_id

DNG15

Identifier Type: -

Identifier Source: org_study_id