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

NCT03960385 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1854

Last updated 2020-09-11

No results posted yet for this study

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

Interventions

BIOLOGICAL

CYD-TDV

Dengue vaccine

Sponsors & Collaborators

  • Pan American Health Organization

    collaborator OTHER

  • State of Parana/Health Department of Parana

    collaborator UNKNOWN

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Centro de Estudos Augusto Leopoldo Ayrosa Galvão

    collaborator UNKNOWN

  • Albert B. Sabin Vaccine Institute

    lead OTHER

Principal Investigators

  • Denise O Garrett, MD, MSc · Albert B. Sabin Vaccine Institute

Eligibility

Min Age
9 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2020-03-01
Completion
2020-03-01
FDA Drug
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03960385 on ClinicalTrials.gov