Dengue FeverNCT01218906
Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Asia
An observational study of Dengue Fever and Fever, run by Sanofi at 11 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue Fever, Fever
- How many people
- 1,500 participants
- Where
- 11 sitesin 5 countries
- Study dates
- Aug 2010to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants aged 2 to 14 years in 5 countries in Asia: Malaysia, Indonesia, Thailand, the Philippines and Viet Nam.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Indonesia3 sites
Study site
Bali
Study site
Bandung, 40161
Study site
Jakarta, 10430
Malaysia3 sites
Study site
George Town
Study site
Kuala Lumpur
Study site
Putrajaya
Philippines3 sites
Study site
Cebu City, 6000
Study site
City of Muntinlupa
Study site
San Pablo
About this study
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.
- Conditions
- Dengue Fever, Fever
- Keywords
- Dengue Fever Fever Dengue Infection
- Medical subject headings
- Dengue, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort Population (Case ) | Participants will be examined for febrile illness to diagnose dengue and to identify common causes of fever. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur SA.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218906
- Sponsor's protocol ID
- CYD34
- Other IDs
- U1111-1112-8378
- Status last verified
- Jan 2018
- First submitted
- 8 Oct 2010
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Asia
- ClinicalTrials.gov ID
- NCT01218906
- Acronym / sponsor ID
- CYD34
- Conditions
- Dengue Fever, Fever
- Keywords
- Dengue Fever Fever Dengue Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort Population (Case ) | – | –Participants will be examined for febrile illness to diagnose dengue and to identify common causes of fever. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants aged 2 to 14 years in 5 countries in Asia: Malaysia, Indonesia, Thailand, the Philippines and Viet Nam.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Results publication: PubMed 23936565Capeding 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Sanofi Pasteur SA.
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue Fever and Fever, run by Sanofi at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Indonesia, Malaysia, Philippines, Thailand, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01218906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.