Augusto Leopoldo Ayrosa Galvão Study Center
São Paulo, Brazil
NCT Number: NCT03960385
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.
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Notify Me9 year–44 year
All sexes
Observational
São Paulo, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for cases:
Case exclusion criteria:
Inclusion criteria
for controls:
Dengue vaccine
Other names: Dengvaxia®
Time frame: Aug 2017 - March 2020
Confirmed (by PCR) case of dengue fever
Time frame: Aug 2017 - March 2020
Hospitalization for severe dengue fever
Albert B. Sabin Vaccine Institute
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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