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

NCT03960385 | Completed DMC FDA Drug

• 1 other identifier: DNG10042
• Study Type: observational
• Target: 1,854
• Locations: 1 country
• Sites: 1

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.

Conditions

Dengue

Keywords

Dengue; Dengvaxia; Parana; Sanofi Pasteur; Vaccine Effectiveness; Maringa; Foz de Iguacu; Paranagua; Brazil

Outcome Measures

Primary Outcomes (1)

• Dengue symptomatic case

  Confirmed (by PCR) case of dengue fever

  Aug 2017 - March 2020

Secondary Outcomes (1)

• Dengue hospitalization

  Aug 2017 - March 2020

Study Arms (2)

Hospitalized and controls

Age-matched case of hospitalized dengue and non-dengue control

Biological: CYD-TDV

Outpatient and controls

Age-matched dengue case and non-dengue control

Biological: CYD-TDV

Interventions

CYD-TDV BIOLOGICAL

Dengue vaccine

Also known as: Dengvaxia®

Hospitalized and controls; Outpatient and controls

Eligibility Criteria

• Age: 9 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Those who have been deprived of their liberty (jails, penitentiaries, drug addicts, etc.) within 15 days before the onset of signs and symptoms
• 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

Sponsors & Collaborators

• Albert B. Sabin Vaccine Institute: lead
• Pan American Health Organization: collaborator
• State of Parana/Health Department of Parana: collaborator
• Ministry of Health, Brazil: collaborator
• Centro de Estudos Augusto Leopoldo Ayrosa Galvão: collaborator

Study Sites (1)

Augusto Leopoldo Ayrosa Galvão Study Center

São Paulo, Brazil

Location

MeSH Terms

Conditions

Dengue

Interventions

CYD-TDV vaccine; Dengue Vaccines

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Denise O Garrett, MD, MSc

  Albert B. Sabin Vaccine Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: August 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)