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

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. Identifier: NCT01293331
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : June 17, 2015
Information provided by (Responsible Party):

Brief Summary:

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 or disease
Dengue Fever Fever

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

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Study Type : Observational
Actual Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Latin America
Study Start Date : August 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Study Cohort (Case )
Participants will be examined for fever in dengue endemic regions

Primary Outcome Measures :
  1. Identification of acute febrile episodes in the cohort [ Time Frame: Up to 18 months after study entry ]
  2. Detection of confirmed or probable dengue infection in the cohort [ Time Frame: Up to 18 months after study entry ]

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01293331

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Campo Grande, Brazil, 79074460
Goiania, Brazil, 74675-020
Natal-RN, Brazil, 59025-600
Vitoria, Brazil, 29040-091
Acacias Meta, Colombia
Aguazul (Casanare), Colombia
Bogota, Colombia
Calarco (Quindio), Colombia
Girardot (Cundinamarca), Colombia
La Tebaida (Quindio), Colombia
Montenegro (Quindio), Colombia
Yopal (Casanare), Colombia
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
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Study Director: Regional Director Sanofi Pasteur SA.
Additional Information:
Publications of Results:
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Responsible Party: Sanofi Identifier: NCT01293331    
Other Study ID Numbers: CYD35
U1111-1112-8481 ( Other Identifier: WHO )
First Posted: February 10, 2011    Key Record Dates
Last Update Posted: June 17, 2015
Last Verified: June 2015
Keywords provided by Sanofi:
Dengue Fever Fever Seroprevalence
Additional relevant MeSH terms:
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Body Temperature Changes
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral