Assessing the Effectiveness of Sanofi Pasteur's Dengue Vaccine (Dengvaxia) Against Hospitalization and Symptomatic Infection in the State of Parana - Brazil

Completed

• Conditions: Dengue
• Interventions: Biological: CYD-TDV

• Registration Number: NCT03960385
• Lead Sponsor: Albert B. Sabin Vaccine Institute

Brief Summary

The study seeks to assess the effectiveness of Sanofi Pasteur´s dengue vaccine (Dengvaxia®) according to the age, dose and municipality of residence in five municipalities of Paraná State. Specific objectives include:

* To assess the effectiveness of Dengvaxia® in preventing dengue hospitalization and dengue symptomatic cases.

* To assess the effectiveness of Dengvaxia® in preventing dengue hospitalization and dengue symptomatic cases according in the following age groups 15 to 18 and 19 to 27 years of age in the municipalities of Maringá, Foz de Iguaçu, Londrina, Sarandi and Paranaguá.

* To assess the effectiveness of Dengvaxia® in preventing dengue hospitalization and dengue symptomatic cases in the following age groups 9 to 14 and 28 to 45 years of age in the municipality of Paranaguá.

Detailed Description

The effectiveness of Sanofi Pasteur´s dengue vaccine (Dengvaxia®) according to the age will be assessed in five municipalities of Paraná State - Maringá, Foz de Iguaçu, Londrina, Sarandi and Paranaguá. Any health service located in each of the five municipalities may report a suspected dengue case. However, in all five municipalities, there is a large public emergency service, the UPA. There are currently three UPA in Londrina, two in Maringá and Foz do Iguaҫu and one each in Paranaguá and Sarandi. These facilities are responsible for reporting the majority of suspected dengue cases. In Londrina and Maringá, the private health sector also provides emergency care. The implementation of the study protocol adds a collection of a blood sample for PCR to the existing protocol for addressing suspected dengue cases among individuals within the target vaccination age groups.

The study will count on the activities already carried out by teams of epidemiological surveillance of dengue intensifying the identification of the serotype through the laboratory method RT-PCR (Reverse Transcription Polymerase Chain Reaction) in real time. In addition, the investigators will identify hospitals and health units that attend dengue cases for sample collection, to perform real-time RT-PCR and initial processing of the blood samples collected from the controls.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-23
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1854

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospitalized and controls	CYD-TDV	Age-matched case of hospitalized dengue and non-dengue control
Outpatient and controls	CYD-TDV	Age-matched dengue case and non-dengue control

Primary Outcome Measures

Name	Time	Method
Dengue symptomatic case	Aug 2017 - March 2020	Confirmed (by PCR) case of dengue fever

Secondary Outcome Measures

Name	Time	Method
Dengue hospitalization	Aug 2017 - March 2020	Hospitalization for severe dengue fever

Trial Locations

Locations (1)

Augusto Leopoldo Ayrosa Galvão Study Center; 🇧🇷 São Paulo, Brazil