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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).
Prospective cohort study.
The study period initially planned to be two years, is extended by one year to cover one additional dengue season.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study cohort | Other | Children age 5 to 13 years at the time of enrollment, selected from schools in Fortaleza. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Socio-demographic information, medical history, yellow fever vaccination history and dengue suspicion data collection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All Laboratory-confirmed Symptomatic Dengue Infection | 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. | At Year 1 (2012) |
| Incidence of All Laboratory-confirmed Symptomatic Dengue Infection | 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. | At Year 2 (2013) |
| Incidence of All Laboratory-confirmed Symptomatic Dengue Infection | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fortaleza | Ceará | 60430 160 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32342838 | Derived | C B Coelho I, Haguinet F, B Colares JK, C B Coelho Z, M C Araujo F, Dias Schwarcz W, Duarte AC, Borges B, Minguet C, Guignard A. Dengue Infection in Children in Fortaleza, Brazil: A 3-Year School-Based Prospective Cohort Study. Am J Trop Med Hyg. 2020 Jul;103(1):100-111. doi: 10.4269/ajtmh.19-0521. Epub 2020 Apr 23. |
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Out of 2117 subjects enrolled in the study, one subject was excluded due to protocol violation. Subjects attended 3 to 4 visits, during a 2 to 3 Year period: subjects enrolled in 2011-2012 who consented for participation of one additional year had 4 scheduled visits over 3 years, and those enrolled in 2013 had 3 scheduled visits over 2 years.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dengue Group | Subjects, male and female, aged 5-13 years at the time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dengue Group | Subjects, male and female, aged 5-13 years at the time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of All Laboratory-confirmed Symptomatic Dengue Infection | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | 95% Confidence Interval | Cases in 1000 person-years | At Year 1 (2012) |
|
Serious Adverse Events were collected on the enrolled subjects throughout the study period (from Day 0 to Year 3).
Adverse Events were not collected as blood sampling was the only invasive procedure performed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dengue Group | Subjects, male and female, aged 5-13 years at the time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| Blood sample collection | Procedure | 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. |
|
| At Year 3 (2014) |
| At Day 0 (At enrollment) |
| Proportion of Subjects With Primary Asymptomatic Dengue Infection | 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. | From Day 0 to Year 3 |
| Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases | 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. | From Year 0 to Year 3 |
| Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection | 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. | At Year 1 (2012) |
| Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection | 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. | At Year 2 (2013) |
| Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection | 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. | At Year 3 (2014) |
| Number of Dengue Infection Cases by Virus Type (DENV) | Among virus types causing dengue infection were DENV-4 in 2012 and 2013 and DENV-1 in 2014, as assessed by PCR. | From Day 0 to Year 3 |
| Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases | 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. | At Year 1 (2012) |
| Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases | 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. | At Year 2 (2013) |
| Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases | 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. | At Year 3 (2014) |
| Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases | 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. | At Year 1 (2012) |
| Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases | 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. | At Year 2 (2013) |
| Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases | 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. | At Year 3 (2014) |
| Number of Working Days Missed of Primary Care Giver 1 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases | The number of days off work from caregiver were recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection. | From 21 up to 35 days post laboratory confirmed dengue onset |
| Number of Working Days Missed of Primary Care Giver 2 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases | The number of days off work from caregiver were recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection. | From 21 up to 35 days post laboratory confirmed dengue onset |
| Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism | 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. | From 21 up to 35 days post laboratory confirmed dengue onset |
| Number of School Days Missed by Subjects | 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. | From 21 up to 35 days post laboratory confirmed dengue onset |
| Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism | 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. | From 21 up to 35 days post laboratory confirmed dengue onset |
| Number of Subjects With Serious Adverse Events (SAEs) | 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. | From Day 0 to Year 3 |
| Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource | Direct medical resource included hospitalization, stay in intensive care units (ICU), medications, diagnostic and therapeutic procedures | From Day 0 to Year 3 |
| Number of Hospitalization Days Due to Laboratory Confirmed Dengue Cases | Length of hospitalization was part of the direct medical resource, associated with dengue infection. | From Day 0 to Year 3 |
| Number of Dengue Infection Episodes - Clinical Symptom Since Onset of Suspected Dengue Cases: Temperature | Temperature, expressed in degrees Celsius (°C), was among symptoms of symptomatic dengue infection. | From Day 0 to Year 3 |
| Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases | 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. | From Day 0 to Year 3 |
| Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Dengue related clinical symptoms included general symptoms, digestive symptoms, respiratory symptoms, hemorrhagic symptoms and any other signs among first symptoms. | From Day 0 to Year 3 |
| Death |
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| Other |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Dengue 5-9Y Group | Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation. |
| OG001 | Dengue 10-17Y Group | Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation. |
|
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| Primary | Incidence of All Laboratory-confirmed Symptomatic Dengue Infection | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | 95% Confidence Interval | Cases in 1000 person-years | At Year 2 (2013) |
|
|
|
| Primary | Incidence of All Laboratory-confirmed Symptomatic Dengue Infection | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | 95% Confidence Interval | Cases in 1000 person-years | At Year 3 (2014) |
|
|
|
| Secondary | Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) 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). | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | 95% Confidence Interval | Proportion of subjects | At Day 0 (At enrollment) |
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| Secondary | Proportion of Subjects With Primary Asymptomatic Dengue Infection | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | 95% Confidence Interval | proportion of subjects | From Day 0 to Year 3 |
|
|
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| Secondary | Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Count of Participants | Participants | From Year 0 to Year 3 |
|
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| Secondary | Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | 95% Confidence Interval | Cases in 1000 person-years | At Year 1 (2012) |
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| Secondary | Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | 95% Confidence Interval | Cases in 1000 person-years | At Year 2 (2013) |
|
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| Secondary | Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | 95% Confidence Interval | Cases in 1000 person-years | At Year 3 (2014) |
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| Secondary | Number of Dengue Infection Cases by Virus Type (DENV) | Among virus types causing dengue infection were DENV-4 in 2012 and 2013 and DENV-1 in 2014, as assessed by PCR. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | Dengue infection cases | From Day 0 to Year 3 |
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| Secondary | Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | Dengue infection cases | At Year 1 (2012) |
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|
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| Secondary | Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | Dengue infection cases | At Year 2 (2013) |
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|
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| Secondary | Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | Dengue infection cases | At Year 3 (2014) |
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| Secondary | Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | Dengue infection cases | At Year 1 (2012) |
|
|
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| Secondary | Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | Dengue infection cases | At Year 2 (2013) |
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|
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| Secondary | Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | Dengue infection cases | At Year 3 (2014) |
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| Secondary | Number of Working Days Missed of Primary Care Giver 1 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases | The number of days off work from caregiver were recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Mean | Standard Deviation | Days | From 21 up to 35 days post laboratory confirmed dengue onset |
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| Secondary | Number of Working Days Missed of Primary Care Giver 2 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases | The number of days off work from caregiver were recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Mean | Standard Deviation | Days | From 21 up to 35 days post laboratory confirmed dengue onset |
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|
|
| Secondary | Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | Dengue infection cases | From 21 up to 35 days post laboratory confirmed dengue onset |
|
|
|
| Secondary | Number of School Days Missed by Subjects | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Mean | Standard Deviation | Days | From 21 up to 35 days post laboratory confirmed dengue onset |
|
|
|
| Secondary | Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | Dengue infection cases | From 21 up to 35 days post laboratory confirmed dengue onset |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | 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. | The analysis was performed on the Total cohort, which included all subjects enrolled in the study. | Posted | Count of Participants | Participants | From Day 0 to Year 3 |
|
|
|
| Secondary | Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource | Direct medical resource included hospitalization, stay in intensive care units (ICU), medications, diagnostic and therapeutic procedures | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | Dengue infection cases | From Day 0 to Year 3 |
|
|
|
| Secondary | Number of Hospitalization Days Due to Laboratory Confirmed Dengue Cases | Length of hospitalization was part of the direct medical resource, associated with dengue infection. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Mean | Standard Deviation | Days | From Day 0 to Year 3 |
|
|
|
| Secondary | Number of Dengue Infection Episodes - Clinical Symptom Since Onset of Suspected Dengue Cases: Temperature | Temperature, expressed in degrees Celsius (°C), was among symptoms of symptomatic dengue infection. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Mean | Standard Deviation | °C | From Day 0 to Year 3 |
|
|
|
| Secondary | Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases | 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. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | dengue infection cases | From Day 0 to Year 3 |
|
|
|
| Secondary | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Dengue related clinical symptoms included general symptoms, digestive symptoms, respiratory symptoms, hemorrhagic symptoms and any other signs among first symptoms. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol. | Posted | Number | dengue infection cases | From Day 0 to Year 3 |
|
|
|
| 0 |
| 0 |
| 0 |
| 2,117 |
| 0 |
| 0 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
|
| IgG, 7 years old at enrollment |
|
|
| IgG, 8 years old at enrollment |
|
|
| IgG, 9 years old at enrollment |
|
|
| IgG, 10 years old at enrollment |
|
|
| IgG, 11 years old at enrollment |
|
|
| IgG, 12 years old at enrollment |
|
|
| IgG, 13 years old at enrollment |
|
|
| IgG, Total |
|
|
|
| Asymptomatic dengue, 2014 |
|
|
| Total |
|
|
|
| Secondary, laboratory confirmed cases |
|
|
| Secondary, probable cases |
|
|
| Unknown, laboratory confirmed cases |
|
|
| Unknown, probable cases |
|
|
| Total, laboratory confirmed cases |
|
|
| Total, probable cases |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Primary care giver 1, Not applicable |
|
| Primary care giver 2, Positive |
|
| Primary care giver 2, Negative |
|
| Primary care giver 2, Missing confirmed |
|
| Primary care giver 2, Not applicable |
|
| Title | Measurements |
|---|---|
|
| Not applicable |
|
| Title | Measurements |
|---|---|
|
| Hospitalized in a study hospital, positive |
|
| Hospitalized in a study hospital, negative |
|
| Hospitalized in a study hospital, unknown |
|
| Title | Measurements |
|---|---|
|
| 35 - 35.4 °C |
|
| 35.5 - 35.9 °C |
|
| 36 - 36.4 °C |
|
| 36.5 - 36.9 °C |
|
| 37 - 37.4 °C |
|
| 37.5 - 37.9 °C |
|
| 38 - 38.4 °C |
|
| 38.5 - 38.9 °C |
|
| 39 - 39.4 °C |
|
| 39.5 - 39.9 °C |
|
| Unknown |
|
| Title | Measurements |
|---|---|
|
| Joint pain |
|
| Chills |
|
| Rash |
|
| Itching |
|
| At least one digestive sign among first symptoms |
|
| Abdominal pain |
|
| Nausea or vomiting |
|
| Diarrhea |
|
| At least one respiratory sign among first symptoms |
|
| Cough |
|
| Nasal congestion |
|
| Sore throat |
|
| Dyspnea |
|
| At least one hemorrhagic sign among first symptoms |
|
| Petechia |
|
| Purpura/ecchymosis |
|
| Hematemesis [vomiting of blood] |
|
| Melena/hematochezia [blood in stool] |
|
| Gingival bleeding |
|
| Epistaxis |
|
| Urinary tract bleeding |
|
| Unusual vaginal bleeding |
|
| At least one other signs among first symptoms |
|
| Pallor or cool skin |
|
| Conjunctivis |
|
| Lethargy or restlessness |
|
| Dizziness |
|
| Thoracic pain |
|
| Other |
|