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CompletedNCT01218906Updated Jan 16, 2018

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

An observational study in Dengue Fever and Fever, sponsored by Sanofi. Completed at 11 sites in 5 countries. Open to participants aged 2 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-16.

Sponsored by Sanofi · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
2 Years to 14 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Dengue Fever
  • Fever

Keywords

  • Dengue Fever Fever Dengue Infection
03

In context

Dengue

279 studies on the registry are indexed under Dengue; 45 are open to participants now.

This study's enrollment of 1,500 is above the median of 595 across 78 observational studies indexed under Dengue.

Browse Dengue studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (actual)

Groups and cohorts

  • Cohort Population (Case )

    Participants will be examined for febrile illness to diagnose dengue and to identify common causes of fever.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

11 sites
  • Bali, Indonesia
  • Bandung, 40161, Indonesia
  • Jakarta, 10430, Indonesia
  • Kuala Lumpur, Malaysia
  • Penang, Malaysia
  • Putrajaya, Malaysia
  • Cebu City, 6000, Philippines
  • Muntinlupa City, Philippines
  • San Pablo, Philippines
  • Bangkok, 10400, Thailand
  • My Tho City, Vietnam
08

References and documents

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. PubMed 23936565 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01218906
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Oct 11, 2010
Start date
Aug 2010
Primary completion
Nov 2011
Completion
Mar 2012
Last update
Jan 16, 2018

Study contacts

Medical Director
study director · Sanofi Pasteur SA.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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