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| Name | Class |
|---|---|
| Pan American Health Organization | OTHER |
| State of Parana/Health Department of Parana | UNKNOWN |
| Ministry of Health, Brazil | OTHER_GOV |
| Centro de Estudos Augusto Leopoldo Ayrosa Galvão |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospitalized and controls | Age-matched case of hospitalized dengue and non-dengue control |
| |
| Outpatient and controls | Age-matched dengue case and non-dengue control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYD-TDV | Biological | Dengue vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dengue symptomatic case | Confirmed (by PCR) case of dengue fever | Aug 2017 - March 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| Dengue hospitalization | Hospitalization for severe dengue fever | Aug 2017 - March 2020 |
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Inclusion criteria for cases:
Case exclusion criteria:
• Those who have been deprived of their liberty (jails, penitentiaries, drug addicts, etc.) within 15 days before the onset of signs and symptoms
Inclusion criteria for controls:
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The effectiveness of Sanofi Pasteur´s dengue vaccine (Dengvaxia®) according to age will be assessed in 5 municipalities of Paraná State - Maringá, Foz de Iguaçu, Londrina, Sarandi and Paranaguá. The municipalities were chosen because they are of medium size and have a history of dengue. The first 4 present a historical series of occurrence of dengue since the 1990s, while in Paranaguá the history of the disease is more recent. Any health service located in each of the five municipalities may report a suspected dengue case. In all five municipalities, there is a large public emergency service, the UPA, which is responsible for reporting the majority of suspected dengue cases. In Londrina and Maringá, the private health sector also provides emergency care.
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| Name | Affiliation | Role |
|---|---|---|
| Denise O Garrett, MD, MSc | Albert B. Sabin Vaccine Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusto Leopoldo Ayrosa Galvão Study Center | São Paulo | Brazil |
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| UNKNOWN |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
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| ID | Term |
|---|---|
| C000603176 | CYD-TDV vaccine |
| D053059 | Dengue Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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