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Completed

NCT Number: NCT03960385

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.

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Key information

Age range

9 year–44 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Augusto Leopoldo Ayrosa Galvão Study Center

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for cases:

  • Individuals living in the municipalities of Sarandi, Paranaguá, Londrina, Maringá or Foz de Iguaçu in the three stages of vaccination
  • Individuals with ages ranging from 9 to 44 years for the municipality of Paranaguá and 15 to 27 years for the municipalities of Sarandi, Londrina, Maringá and Foz de Iguaçu
  • All participants who are 18 years of age or older sign the informed consent form
  • All minors under the age of 18 who sign the consent form and have the consent form signed by a guardian for the minor
  • Case with virological isolation of one of the dengue viruses

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:

  • Individuals without symptoms for dengue in the 15 days prior to the onset of symptoms of the case
  • IgM negative for dengue
  • Individuals living in the municipalities of Paranaguá, Londrina, Maringá, Sarandi or Foz de Iguaçu in the three stages of vaccination
  • Belongs to the same age group as case
  • Participants aged between 9 and 44 years for the municipality of Paranaguá
  • Participants 15 to 27 years for the municipalities of Maringá, Foz de Iguaçu, Londrina and Sarandi
  • Resides in the same neighborhood as the case, study at the same institution as the case or work in the same company as the case for at least 15 days before the onset of the case symptoms
  • Participants that are 18 years of age or older and who sign the informed consent form
  • All minors under the age of 18 who sign the consent form and have the consent form signed by a guardian for the minor

Treatment and study plan

CYD-TDV

Biological

Dengue vaccine

Other names: Dengvaxia®

Primary outcomes

  1. Dengue symptomatic case

    Time frame: Aug 2017 - March 2020

    Confirmed (by PCR) case of dengue fever

Secondary outcomes

  1. Dengue hospitalization

    Time frame: Aug 2017 - March 2020

    Hospitalization for severe dengue fever

Sponsors and collaborators

Lead sponsor

Albert B. Sabin Vaccine Institute

Other

Collaborators

  • Centro de Estudos Augusto Leopoldo Ayrosa Galvão
  • Ministry of Health, Brazil
  • Pan American Health Organization
  • State of Parana/Health Department of Parana

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 23, 2019
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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