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

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.
 
ClinicalTrials.gov Identifier: NCT01218906
Recruitment Status : Completed
First Posted : October 11, 2010
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date October 8, 2010
First Posted Date October 11, 2010
Last Update Posted Date January 16, 2018
Study Start Date August 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 8, 2010)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01218906 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Asia
Official Title Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Asia
Brief Summary

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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Dengue Fever
  • Fever
Intervention Not Provided
Study Groups/Cohorts Cohort Population (Case )
Participants will be examined for febrile illness to diagnose dengue and to identify common causes of fever.
Publications * Capeding MR, Chua MN, Hadinegoro SR, Hussain II, Nallusamy R, Pitisuttithum P, Rusmil K, Thisyakorn U, Thomas SJ, Huu Tran N, Wirawan DN, Yoon IK, Bouckenooghe A, Hutagalung Y, Laot T, Wartel TA. Dengue and other common causes of acute febrile illness in Asia: an active surveillance study in children. PLoS Negl Trop Dis. 2013 Jul 25;7(7):e2331. doi: 10.1371/journal.pntd.0002331. Print 2013.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 8, 2010)
1500
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2012
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 14 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Indonesia,   Malaysia,   Philippines,   Thailand,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number NCT01218906
Other Study ID Numbers CYD34
U1111-1112-8378 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sanofi
Study Sponsor Sanofi
Collaborators Not Provided
Investigators
Study Director: Medical Director Sanofi Pasteur SA.
PRS Account Sanofi
Verification Date January 2018