N/A
N=2,004
A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia
Dengue
Bottom Line
View on ClinicalTrials.gov: NCT02570152 ↗Enrolled (actual)
2,004
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Dengue (LCD) Overall, and by Age Group — 21.25; 22.69; 12.76; 9.16 Person-year rate ( Per 1000)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood sample collection (Procedure)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Dengue (LCD) Overall, and by Age Group |
21.25; 22.69; 12.76; 9.16; 14.21 | — |
| SECONDARY Incidence Rate of Acute Febrile Illness (AFI) Due to Non-Laboratory Confirmed Dengue (Non-LCD) Overall, and by Age Group |
104.31; 84.8; 43.76; 17.3; 47.3 | — |
| SECONDARY Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 1 Dengue Overall, and by Age Group. |
0; 3.59; 0; 1.53; 1.55 | — |
| SECONDARY Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 2 Dengue Overall, and by Age Group |
21.25; 17.94; 12.76; 6.61; 11.89 | — |
| SECONDARY Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 3 Dengue Overall, and by Age Group |
0; 1.2; 0; 1.02; 0.78 | — |
| SECONDARY Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 4 Dengue Overall, and by Age Group |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. |
51; 51; 51; 51; 51; 50 | — |
| SECONDARY Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD |
11; 11; 11; 11; 11; 11 | — |
| SECONDARY Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD |
159; 159; 159; 157; 158; 158 | — |
| SECONDARY Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD |
16; 16; 16; 15; 16; 16 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure |
— | — |
Summary
The purpose of this study is to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of South Asia.
Eligibility Criteria
Inclusion Criteria
- Subject and/or subject's parent(s)/legally acceptable representative(s) (LAR[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. (e.g., willingness to go to the hospital/clinic for visit[s] in case of AFI, able to observe the signs of dengue and to understand how to take and report body temperature, etc.).
- Signed/thumb-printed (and video recorded if required by law) informed consent (and assent if applicable) must be obtained from the subject/subject's parent(s)/LAR(s) at the hospital/clinic or during a home visit. If the subject/subject's parent(s)/LAR(s) are illiterate, the informed consent form (ICF) (or informed assent form [IAF] when applicable) will be countersigned by an impartial witness.
- Subject is part of a household with at least one child (aged less than 18 years) and in which informed consent (and assent if applicable) to study participation was obtained from at least one adult and one child.
- Male or female aged between and including 6 months and 50 years at the time of enrolment.
- Subject who plans, at the time of enrolment, to remain at same residence/study area during the two-year study period.
Exclusion Criteria
- Child in care.
- Participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator's judgement.
- Terminal illness based on investigator's judgement.
- Mental incapacity based on investigator's judgement.
Data sourced from ClinicalTrials.gov (NCT02570152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.