Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children

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: NCT01391819
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : April 26, 2017
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The aim of this study is to establish an active surveillance in order to generate dengue disease burden estimates including incidence rates, prevalence data, clinical presentation and cost of illness in Forteleza (Brazil).

Condition or disease Intervention/treatment Phase
Dengue Other: Data collection Procedure: Blood sample collection Not Applicable

Detailed Description:

Prospective cohort study.

The study period initially planned to be two years, is extended by one year to cover one additional dengue season.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2117 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Epidemiological Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children
Actual Study Start Date : September 6, 2011
Actual Primary Completion Date : January 30, 2015
Actual Study Completion Date : January 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arm Intervention/treatment
Study cohort
Children age 5 to 13 years at the time of enrollment, selected from schools in Fortaleza.
Other: Data collection
Socio-demographic information, medical history, yellow fever vaccination history and dengue suspicion data collection.

Procedure: Blood sample collection
A blood sample will be collected at each of the three scheduled study visits and any time during the study that dengue is suspected. Samples collected at scheduled visits will be tested for anti-dengue antibodies. Samples collected at visits for dengue suspicion will be tested for dengue diagnosis.




Primary Outcome Measures :
  1. Incidence of All Laboratory-confirmed Symptomatic Dengue Infection [ Time Frame: At Year 1 (2012) ]
    Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through dengue virus identification through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.

  2. Incidence of All Laboratory-confirmed Symptomatic Dengue Infection [ Time Frame: At Year 2 (2013) ]
    Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through dengue virus identification through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.

  3. Incidence of All Laboratory-confirmed Symptomatic Dengue Infection [ Time Frame: At Year 3 (2014) ]
    Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through dengue virus identification through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.


Secondary Outcome Measures :
  1. Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment [ Time Frame: At Day 0 (At enrollment) ]
    This outcome measures the occurrence of past dengue infections among subjects who had laboratory results. Proportion was estimated from logistic generalized estimating equations models (GEE) taking the clustering effect of the school into account and was presented per subject enrolment age. Immune response against dengue was assessed via Enzyme-linked Immunosorbent Assay (ELISA).

  2. Proportion of Subjects With Primary Asymptomatic Dengue Infection [ Time Frame: From Day 0 to Year 3 ]
    Asymptomatic dengue primary infection was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits, without suspicion of dengue. Proportion of asymptomatic dengue primary infection was analyzed among subjects who had no past dengue infection reported before the beginning of the period.

  3. Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases [ Time Frame: From Year 0 to Year 3 ]
    A case of primary or secondary symptomatic dengue infection was defined as laboratory confirmed or probable symptomatic dengue case whose previous sample collected at scheduled Visits 1- 4 (Day 0- Year 3) to detect anti-dengue IgG antibodies was seronegative or seropositive, respectively. A probable dengue case was defined as a suspected symptomatic dengue case with the following laboratory findings: -anti-dengue IgM or anti-dengue IgG positivity in at least one sample (in either blood sample 1 or 2) AND no evidence of viremia (negative dengue virus identification through RT-qPCR) in blood sample 1 AND no evidence of anti-dengue Ig M or IgG seroconversion between blood sample 1 and blood sample 2.

  4. Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection [ Time Frame: At Year 1 (2012) ]
    Incidence of laboratory confirmed or probable symptomatic dengue infection was assessed by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.

  5. Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection [ Time Frame: At Year 2 (2013) ]
    Incidence of laboratory confirmed or probable symptomatic dengue infection was assessed by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.

  6. Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection [ Time Frame: At Year 3 (2014) ]
    Incidence of laboratory confirmed or probable symptomatic dengue infection was assessed by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.

  7. Number of Dengue Infection Cases by Virus Type (DENV) [ Time Frame: From Day 0 to Year 3 ]
    Among virus types causing dengue infection were DENV-4 in 2012 and 2013 and DENV-1 in 2014, as assessed by PCR.

  8. Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases [ Time Frame: At Year 1 (2012) ]
    Primary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative. Analysis was done by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category "number of subjects analysed" has been populated with the number of enrolled subjects seronegative for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum.

  9. Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases [ Time Frame: At Year 2 (2013) ]
    Primary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative. Analysis was done by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category "number of subjects analysed" has been populated with the number of enrolled subjects seronegative for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum.

  10. Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases [ Time Frame: At Year 3 (2014) ]
    Primary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative. Analysis was done by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category "number of subjects analysed" has been populated with the number of enrolled subjects seronegative for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum.

  11. Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases [ Time Frame: At Year 1 (2012) ]
    Secondary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seropositive. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category "number of subjects analysed" has been populated with the number of enrolled subjects seropositive for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum.

  12. Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases [ Time Frame: At Year 2 (2013) ]
    Secondary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seropositive. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category "number of subjects analysed" has been populated with the number of enrolled subjects seropositive for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum.

  13. Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases [ Time Frame: At Year 3 (2014) ]
    Secondary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seropositive. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category "number of subjects analysed" has been populated with the number of enrolled subjects seropositive for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum.

  14. Number of Working Days Missed of Primary Care Giver 1 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases [ Time Frame: From 21 up to 35 days post laboratory confirmed dengue onset ]
    The number of days off work from caregiver were recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection.

  15. Number of Working Days Missed of Primary Care Giver 2 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases [ Time Frame: From 21 up to 35 days post laboratory confirmed dengue onset ]
    The number of days off work from caregiver were recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection.

  16. Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism [ Time Frame: From 21 up to 35 days post laboratory confirmed dengue onset ]
    The number of laboratory confirmed dengue infections with primary caregivers missing from work was recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection.

  17. Number of School Days Missed by Subjects [ Time Frame: From 21 up to 35 days post laboratory confirmed dengue onset ]
    The number of school days missed by subjects due to dengue infection were recorded as part of the dengue active surveillance and indirect resource utilization associated with symptomatic dengue infection.

  18. Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism [ Time Frame: From 21 up to 35 days post laboratory confirmed dengue onset ]
    The number of laboratory confirmed dengue infection cases with subjects missing from school due to dengue infection were recorded as part of the dengue active surveillance and indirect resource utilization associated with symptomatic dengue infection.

  19. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Day 0 to Year 3 ]
    Serious adverse events (SAEs) were collected on the enrolled subjects. SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject.

  20. Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource [ Time Frame: From Day 0 to Year 3 ]
    Direct medical resource included hospitalization, stay in intensive care units (ICU), medications, diagnostic and therapeutic procedures

  21. Number of Hospitalization Days Due to Laboratory Confirmed Dengue Cases [ Time Frame: From Day 0 to Year 3 ]
    Length of hospitalization was part of the direct medical resource, associated with dengue infection.

  22. Number of Dengue Infection Episodes - Clinical Symptom Since Onset of Suspected Dengue Cases: Temperature [ Time Frame: From Day 0 to Year 3 ]
    Temperature, expressed in degrees Celsius (°C), was among symptoms of symptomatic dengue infection.

  23. Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases [ Time Frame: From Day 0 to Year 3 ]
    Temperature intervals assessed varied from hypothermia 33.5 to 36.4 degrees Celsius (°C), to normal temperature 36.5-35.9 °C and hyperthermia 37 - 39.9 °C, or were unknown.

  24. Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms [ Time Frame: From Day 0 to Year 3 ]
    Dengue related clinical symptoms included general symptoms, digestive symptoms, respiratory symptoms, hemorrhagic symptoms and any other signs among first symptoms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female between 5 and 13 years of age (including children at least 5 years of age and excluding children who reached their fourteenth birthday) at the time of enrollment.
  • Written informed consent (and assent when applicable).
  • Subjects who the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol (e.g. willingness to do a hospital visit in case of dengue suspicion, willingness to attend the study hospital return for follow-up visits, able to observe for signs of dengue, understand how to take a temperature, etc).
  • Subjects who plan to attend one of the study schools for two school years following enrollment.

Exclusion Criteria:

  • Subjects planning to move from the study area during the two school years following enrollment.
  • Child in care.
  • Enrollment in another study that would conflict with the current study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391819


Locations
Layout table for location information
Brazil
GSK Investigational Site
Fortaleza, Ceará, Brazil, 60430 160
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline

Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01391819     History of Changes
Other Study ID Numbers: 112994
First Posted: July 12, 2011    Key Record Dates
Results First Posted: April 26, 2017
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GlaxoSmithKline:
Brazil
Incidence
Dengue virus
Dengue
Dengue infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral