Dengue Clinical Trial
Official title:
Assessing the Effectiveness of Sanofi Pasteur's Dengue Vaccine (Dengvaxia) Against Hospitalization and Symptomatic Infection in the State of Parana - Brazil
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.
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 IguaŅ«u 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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