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

11 januari 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

1500

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Filippinerna
- - Cebu City, Filippinerna, 6000
  - Muntinlupa City, Filippinerna
  - San Pablo, Filippinerna
Indonesien
- - Bali, Indonesien
  - Bandung, Indonesien, 40161
  - Jakarta, Indonesien, 10430
Malaysia
- - Kuala Lumpur, Malaysia
  - Penang, Malaysia
  - Putrajaya, Malaysia
Thailand
- - Bangkok, Thailand, 10400
Vietnam
- - My Tho City, Vietnam

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

2 år till 14 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: Kohort
Tidsperspektiv: Blivande

Antal grupper/kohorter

Kohorter och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått	Tidsram
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 Tidsram: Up to 12 months after enrollment	Up to 12 months after enrollment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sanofi

Utredare

Studierektor: Medical Director, Sanofi Pasteur SA.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2010

Primärt slutförande (Faktisk)

1 november 2011

Avslutad studie (Faktisk)

1 mars 2012

Studieregistreringsdatum

Först inskickad

8 oktober 2010

Först inskickad som uppfyllde QC-kriterierna