Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Asia

January 11, 2018 updated by: Sanofi

The purpose of this study is to detect acute febrile episodes and dengue infection in five Asian countries, to assess dengue seroprevalence, and to assess surveillance infrastructure at investigational sites in anticipation of a Phase 3 efficacy trial of a vaccine to prevent dengue infection.

The primary objectives are:

  • To identify acute febrile episodes among the cohort in order to detect the presence of dengue infection.
  • To develop operational infrastructure for potential Phase III dengue efficacy trial sites.
  • To describe the dengue seroprevalence among the cohort at baseline and at the end of the study.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Bali, Indonesia
      • Bandung, Indonesia, 40161
      • Jakarta, Indonesia, 10430
  • Malaysia
      • Kuala Lumpur, Malaysia
      • Penang, Malaysia
      • Putrajaya, Malaysia
  • Philippines
      • Cebu City, Philippines, 6000
      • Muntinlupa City, Philippines
      • San Pablo, Philippines
  • Thailand
      • Bangkok, Thailand, 10400
  • Vietnam
      • My Tho City, Vietnam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants aged 2 to 14 years in 5 countries in Asia: Malaysia, Indonesia, Thailand, the Philippines and Viet Nam.

Description

Inclusion Criteria :

  • Aged 2 to 14 years on the day of inclusion and resident of the site zone
  • Subject in good health, based on medical history and physical examination
  • Assent form has been signed and dated by the subject (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 subject and/or an independent witness if required by local regulations)
  • Subject able to attend all scheduled visits and to comply with all study procedures
  • For a female of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to enrollment.

Exclusion Criteria :

  • Known pregnancy at the Enrollment Visit
  • 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 subject'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.

Temporary Contraindications

A prospective subject should not be included in the study until the following condition and/or symptoms are resolved:

  • Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cohort Population (Case )
Participants will be examined for febrile illness to diagnose dengue and to identify common causes of fever.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information on the incidences of febrile episodes and confirmed and probable Dengue fever, and to determine other causes of febrile episodes in the cohort population
Time Frame: Up to 12 months after enrollment
Up to 12 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Medical Director, Sanofi Pasteur SA.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimate)

October 11, 2010

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYD34
  • U1111-1112-8378 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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