Study of Febrile Illness for Dengue-Endemic Areas in Latin America

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01293331
First received: February 9, 2011
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to detect acute febrile episodes and dengue infection in five Latin American countries to assess dengue seroprevalence.

Primary objectives:

  • To identify acute febrile episodes among the cohort in order to detect the presence of dengue infection.
  • To describe the dengue seroprevalence among the cohort at baseline and at the end of the study.

Condition
Dengue Fever
Fever

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Latin America

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Identification of acute febrile episodes in the cohort [ Time Frame: Up to 18 months after study entry ] [ Designated as safety issue: No ]
  • Detection of confirmed or probable dengue infection in the cohort [ Time Frame: Up to 18 months after study entry ] [ Designated as safety issue: No ]

Enrollment: 3000
Study Start Date: August 2010
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Cohort (Case )
Participants will be examined for fever in dengue endemic regions

Detailed Description:

All participants will make two visits to a study site, an enrollment visit and a termination visit. Additional visits will be made if febrile episodes occur: an acute visit and a convalescent visit. Participants or their parents/guardians will be contacted weekly to monitor the occurrence of febrile episodes and ensure appropriate assessment and care.

No vaccine will be provided or administered in this study

  Eligibility

Ages Eligible for Study:   9 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Participants aged 9 to 16 years in 4 countries in Latin America: Brazil, Mexico, Colombia and Puerto Rico

Criteria

Inclusion Criteria :

  • Aged 9 to 16 years on the day of inclusion and resident of the site zone
  • Participant in good health, based on medical history and physical examination
  • Assent form has been signed and dated by the participant (if required by local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by the participant and/or an independent witness if required by local regulations)
  • Participant able to attend all scheduled visits and to comply with all study procedures

Exclusion Criteria :

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding enrollment
  • Planned participation in another clinical trial during the present study period
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
  • Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with study procedures
  • Receipt of blood or blood-derived products in the past 3 months
  • Receipt of any vaccine in the 4 weeks preceding the day of enrollment except for pandemic influenza vaccination, which may be received at least 2 weeks before enrollment
  • Planned receipt of any vaccine in the 4 weeks following enrollment
  • Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293331

Locations
Brazil
Campo Grande, Brazil, 79074460
Goiania, Brazil, 74675-020
Natal-RN, Brazil, 59025-600
Vitoria, Brazil, 29040-091
Colombia
Acacias Meta, Colombia
Aguazul (Casanare), Colombia
Bogota, Colombia
Calarco (Quindio), Colombia
Girardot (Cundinamarca), Colombia
La Tebaida (Quindio), Colombia
Montenegro (Quindio), Colombia
Yopal (Casanare), Colombia
Mexico
Minatitlan, Veracruz Mexico, Mexico, 96760
Veracruz, Veracruz Mexico, Mexico, 91900
Municipio de Cd. Mante Tamaulipas, Mexico
Quintana Roo., Mexico
Puerto Rico
Guayama, Puerto Rico, 00784
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Regional Director Sanofi Pasteur SA.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01293331     History of Changes
Other Study ID Numbers: CYD35, U1111-1112-8481
Study First Received: February 9, 2011
Last Updated: August 2, 2012
Health Authority: United States: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Mexico: Ministry of Health
Brazil: Ministry of Health

Keywords provided by Sanofi:
Dengue Fever Fever Seroprevalence

Additional relevant MeSH terms:
Dengue
Fever
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014