Assessing the Effectiveness of Sanofi Pasteur's Dengue Vaccine (Dengvaxia) Against Hospitalization and Symptomatic Infection in the State of Parana - Brazil
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|ClinicalTrials.gov Identifier: NCT03960385|
Recruitment Status : Completed
First Posted : May 23, 2019
Last Update Posted : September 11, 2020
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.
|Condition or disease||Intervention/treatment|
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 Type :||Observational|
|Actual Enrollment :||1854 participants|
|Official Title:||Assessing the Effectiveness of Sanofi Pasteur's Dengue Vaccine (Dengvaxia) Against Hospitalization and Symptomatic Infection in the State of Parana - Brazil|
|Actual Study Start Date :||August 1, 2017|
|Actual Primary Completion Date :||March 1, 2020|
|Actual Study Completion Date :||March 1, 2020|
Hospitalized and controls
Age-matched case of hospitalized dengue and non-dengue control
Other Name: Dengvaxia®
Outpatient and controls
Age-matched dengue case and non-dengue control
Other Name: Dengvaxia®
- Dengue symptomatic case [ Time Frame: Aug 2017 - March 2020 ]Confirmed (by PCR) case of dengue fever
- Dengue hospitalization [ Time Frame: Aug 2017 - March 2020 ]Hospitalization for severe dengue fever
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960385
|Augusto Leopoldo Ayrosa Galvão Study Center|
|São Paulo, Brazil|
|Study Director:||Denise O Garrett, MD, MSc||Albert B. Sabin Vaccine Institute|