Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing the Effectiveness of Sanofi Pasteur's Dengue Vaccine (Dengvaxia) Against Hospitalization and Symptomatic Infection in the State of Parana - Brazil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03960385
Recruitment Status : Completed
First Posted : May 23, 2019
Last Update Posted : September 11, 2020
Sponsor:
Collaborators:
Pan American Health Organization
State of Parana/Health Department of Parana
Ministry of Health of Brazil
Centro de Estudos Augusto Leopoldo Ayrosa Galvão
Information provided by (Responsible Party):
Albert B. Sabin Vaccine Institute

Tracking Information
First Submitted Date May 21, 2019
First Posted Date May 23, 2019
Last Update Posted Date September 11, 2020
Actual Study Start Date August 1, 2017
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 22, 2019)
Dengue symptomatic case [ Time Frame: Aug 2017 - March 2020 ]
Confirmed (by PCR) case of dengue fever
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 22, 2019)
Dengue hospitalization [ Time Frame: Aug 2017 - March 2020 ]
Hospitalization for severe dengue fever
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessing the Effectiveness of Sanofi Pasteur's Dengue Vaccine (Dengvaxia) Against Hospitalization and Symptomatic Infection in the State of Parana - Brazil
Official Title Assessing the Effectiveness of Sanofi Pasteur's Dengue Vaccine (Dengvaxia) Against Hospitalization and Symptomatic Infection in the State of Parana - Brazil
Brief Summary

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.
Detailed Description

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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 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.
Condition Dengue
Intervention Biological: CYD-TDV
Dengue vaccine
Other Name: Dengvaxia®
Study Groups/Cohorts
  • Hospitalized and controls
    Age-matched case of hospitalized dengue and non-dengue control
    Intervention: Biological: CYD-TDV
  • Outpatient and controls
    Age-matched dengue case and non-dengue control
    Intervention: Biological: CYD-TDV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 9, 2020)
1854
Original Estimated Enrollment
 (submitted: May 22, 2019)
2130
Actual Study Completion Date March 1, 2020
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 9 Years to 44 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT03960385
Other Study ID Numbers DNG10042
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Albert B. Sabin Vaccine Institute
Study Sponsor Albert B. Sabin Vaccine Institute
Collaborators
  • Pan American Health Organization
  • State of Parana/Health Department of Parana
  • Ministry of Health of Brazil
  • Centro de Estudos Augusto Leopoldo Ayrosa Galvão
Investigators
Study Director: Denise O Garrett, MD, MSc Albert B. Sabin Vaccine Institute
PRS Account Albert B. Sabin Vaccine Institute
Verification Date September 2020